Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
Study NCT ID:
NCT04510857
Status:
COMPLETED
Last Update Posted:
2025-10-15
First Post:
2020-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Motivating Occupational Virtual Experiences In Therapy for Kids
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adams@bainet.com', 'phone': '4348253435', 'title': 'Richard Adams', 'organization': 'Barron Associates, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pre Jebsen Taylor Hand Function Test (JTHFT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '433.9', 'spread': '225.1', 'groupId': 'OG000'}, {'value': '294.7', 'spread': '217.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-intervention at Baseline', 'description': 'The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post Jebsen Taylor Hand Function Test (JTHFT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '416.6', 'spread': '228.9', 'groupId': 'OG000'}, {'value': '268.3', 'spread': '212.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Intervention at 10 weeks', 'description': 'The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pre Pediatric Motor Activity Log (Amount)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.68', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-intervention at Baseline', 'description': "The Pediatric Motor Activity Log (Amount) is a parent-reported assessment tool designed to evaluate the frequency of use of a child's affected (weaker) upper limb during 22 specific daily activities, such as reaching, grasping, or manipulating objects. For each activity, parents rate how often the child uses their affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child never uses the weaker arm for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as frequently as the stronger arm for that activity. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PMAL data were missing for one UCT subject.'}, {'type': 'SECONDARY', 'title': 'Post Pediatric Motor Activity Log (Amount)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.80', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Intervention at 10 weeks', 'description': "The Pediatric Motor Activity Log (Amount) is a parent-reported assessment tool designed to evaluate the frequency of use of a child's affected (weaker) upper limb during 22 specific daily activities, such as reaching, grasping, or manipulating objects. For each activity, parents rate how often the child uses their affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child never uses the weaker arm for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as frequently as the stronger arm for that activity. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PMAL data were missing for one UCT subject.'}, {'type': 'SECONDARY', 'title': 'Pre Pediatric Motor Activity Log (How Well)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.68', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '0.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-intervention at Baseline', 'description': "The Preschool Pediatric Motor Activity Log (PMAL-How Well) is a parent-reported assessment tool designed to evaluate the quality of use of a child's affected upper limb (weaker arm) during 22 specific daily activities. For each activity, the parent rates the quality of their child's performance using the affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child does not use the weaker arm at all for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as effectively as the stronger arm, with normal or near-normal quality of movement. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PMAL data were missing for one UCT subject.'}, {'type': 'SECONDARY', 'title': 'Post Pediatric Motor Activity Log (How Well)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.25', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '2.98', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Intervention at 10 weeks', 'description': "The Preschool Pediatric Motor Activity Log (PMAL-How Well) is a parent-reported assessment tool designed to evaluate the quality of use of a child's affected upper limb (weaker arm) during 22 specific daily activities. For each activity, the parent rates the quality of their child's performance using the affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child does not use the weaker arm at all for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as effectively as the stronger arm, with normal or near-normal quality of movement. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PMAL data were missing for one UCT subject.'}, {'type': 'SECONDARY', 'title': 'Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '25.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-intervention at Baseline', 'description': "The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function.", 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post Intervention Wolf Motor Function Test Time (WMFT-TIME)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '24.9', 'spread': '40.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Intervention at 10 weeks', 'description': "The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function.", 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.95', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-intervention at Baseline', 'description': "The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement.\n\nThe WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WMFT FA data were missing for one UCT subject.'}, {'type': 'SECONDARY', 'title': 'Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '3.63', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Intervention at 10 weeks', 'description': "The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement.\n\nThe WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WMFT FA data were missing for one UCT subject.'}, {'type': 'SECONDARY', 'title': 'Pre Quality of Upper Extremity Skills Test (QUEST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-intervention at Baseline', 'description': 'Quality of Upper Extremity Skills Test (QUEST) is a standardized assessment tool designed to evaluate upper extremity (UE) function in children with neuromotor disabilities, such as cerebral palsy. This study used only the dissociated movements and grasp function components of the QUEST instrument. Observational criteria were used to assign a value of 0, 1, or 2 for each of 44 items. Individual component scores were summed to create a total score with a range from 0 to 88. A higher value corresponds to a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'QUEST data were missing for 2 HEP subjects and 1 UCT subject.'}, {'type': 'SECONDARY', 'title': 'Post Quality of Upper Extremity Skills Test (QUEST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'OG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.3', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '77.4', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post Intervention at 10 weeks', 'description': 'Quality of Upper Extremity Skills Test (QUEST) is a standardized assessment tool designed to evaluate upper extremity (UE) function in children with neuromotor disabilities, such as cerebral palsy. This study used only the dissociated movements and grasp function components of the QUEST instrument. Observational criteria were used to assign a value of 0, 1, or 2 for each of 44 items. Individual component scores were summed to create a total score with a range from 0 to 88. A higher value corresponds to a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'QUEST data were missing for 2 HEP subjects and 1 UCT subject.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'FG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Only children were considered enrolled in the study. A parent or legal guardian provided permission and the child verbal assented.\n\nOf the subjects enrolled, 2 failed screening tests (described in the protocol) and 2 others dropped out prior to randomization due to medical or personal reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.\n\nMOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.'}, {'id': 'BG001', 'title': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.\n\nUCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '12'}, {'value': '6.5', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '12'}, {'value': '8.5', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis is for subjects enrolled and randomized to a treatment group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-14', 'size': 795695, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-20T17:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigator administrating assessments will be blinded to subject group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention group performs home exercise program using the computer-aided MOVE-IT system for upper extremity therapy.\n\nControl group participants will be followed as they continue to receive their previously prescribed therapy services.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2020-08-09', 'resultsFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-29', 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre Jebsen Taylor Hand Function Test (JTHFT)', 'timeFrame': 'Pre-intervention at Baseline', 'description': 'The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.'}, {'measure': 'Post Jebsen Taylor Hand Function Test (JTHFT)', 'timeFrame': 'Post Intervention at 10 weeks', 'description': 'The JTHFT assesses hand function through timed movements such as simulated page turning, eating, stacking objects, and lifting objects of different size and mass. The JTHFT total score is simply the sum of all timed movements (in seconds). A lower score represents a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Pre Pediatric Motor Activity Log (Amount)', 'timeFrame': 'Pre-intervention at Baseline', 'description': "The Pediatric Motor Activity Log (Amount) is a parent-reported assessment tool designed to evaluate the frequency of use of a child's affected (weaker) upper limb during 22 specific daily activities, such as reaching, grasping, or manipulating objects. For each activity, parents rate how often the child uses their affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child never uses the weaker arm for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as frequently as the stronger arm for that activity. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome."}, {'measure': 'Post Pediatric Motor Activity Log (Amount)', 'timeFrame': 'Post Intervention at 10 weeks', 'description': "The Pediatric Motor Activity Log (Amount) is a parent-reported assessment tool designed to evaluate the frequency of use of a child's affected (weaker) upper limb during 22 specific daily activities, such as reaching, grasping, or manipulating objects. For each activity, parents rate how often the child uses their affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child never uses the weaker arm for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as frequently as the stronger arm for that activity. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome."}, {'measure': 'Pre Pediatric Motor Activity Log (How Well)', 'timeFrame': 'Pre-intervention at Baseline', 'description': "The Preschool Pediatric Motor Activity Log (PMAL-How Well) is a parent-reported assessment tool designed to evaluate the quality of use of a child's affected upper limb (weaker arm) during 22 specific daily activities. For each activity, the parent rates the quality of their child's performance using the affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child does not use the weaker arm at all for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as effectively as the stronger arm, with normal or near-normal quality of movement. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome."}, {'measure': 'Post Pediatric Motor Activity Log (How Well)', 'timeFrame': 'Post Intervention at 10 weeks', 'description': "The Preschool Pediatric Motor Activity Log (PMAL-How Well) is a parent-reported assessment tool designed to evaluate the quality of use of a child's affected upper limb (weaker arm) during 22 specific daily activities. For each activity, the parent rates the quality of their child's performance using the affected arm on a 6-point Likert scale, ranging from 0 to 5. A score of 0 indicates that the child does not use the weaker arm at all for the activity (or the activity is not performed), while a score of 5 indicates that the weaker arm is used as effectively as the stronger arm, with normal or near-normal quality of movement. The reported score is the average of the individual scores for the 22 activities. A higher score represents a better outcome."}, {'measure': 'Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)', 'timeFrame': 'Pre-intervention at Baseline', 'description': "The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function."}, {'measure': 'Post Intervention Wolf Motor Function Test Time (WMFT-TIME)', 'timeFrame': 'Post Intervention at 10 weeks', 'description': "The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function."}, {'measure': 'Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)', 'timeFrame': 'Pre-intervention at Baseline', 'description': "The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement.\n\nThe WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function."}, {'measure': 'Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)', 'timeFrame': 'Post Intervention at 10 weeks', 'description': "The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement.\n\nThe WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function."}, {'measure': 'Pre Quality of Upper Extremity Skills Test (QUEST)', 'timeFrame': 'Pre-intervention at Baseline', 'description': 'Quality of Upper Extremity Skills Test (QUEST) is a standardized assessment tool designed to evaluate upper extremity (UE) function in children with neuromotor disabilities, such as cerebral palsy. This study used only the dissociated movements and grasp function components of the QUEST instrument. Observational criteria were used to assign a value of 0, 1, or 2 for each of 44 items. Individual component scores were summed to create a total score with a range from 0 to 88. A higher value corresponds to a better outcome.'}, {'measure': 'Post Quality of Upper Extremity Skills Test (QUEST)', 'timeFrame': 'Post Intervention at 10 weeks', 'description': 'Quality of Upper Extremity Skills Test (QUEST) is a standardized assessment tool designed to evaluate upper extremity (UE) function in children with neuromotor disabilities, such as cerebral palsy. This study used only the dissociated movements and grasp function components of the QUEST instrument. Observational criteria were used to assign a value of 0, 1, or 2 for each of 44 items. Individual component scores were summed to create a total score with a range from 0 to 88. A higher value corresponds to a better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cerebral palsy', 'Occupational therapy', 'Virtual reality', 'Therapy games', 'Pediatric hemiplegia', 'Teletherapy'], 'conditions': ['Virtual Reality', 'Occupational Therapy']}, 'descriptionModule': {'briefSummary': 'A rater-blinded randomized controlled trial (RCT) will be conducted to compare the efficacy of MOVE-IT use in a remotely supervised home exercise program (HEP) to usual care for recovery of upper extremity (UE) function in children with hemiplegia.', 'detailedDescription': 'A rater-blinded randomized controlled trial (RCT) will be conducted to compare the efficacy of MOVE-IT use in a remotely supervised home exercise program (HEP) to usual care for recovery of upper extremity (UE) function in children with hemiplegia, and to acquire evidence of usability and acceptance of the MOVE-IT system by children and parents. The University of Virginia (UVA) will serve as coordinating center and single IRB for the two-site RCT that includes UVA and Duke University.\n\nThe primary Phase II investigational objective is to show a differential effect on the pre- to post-intervention change in UE motor function between an interventional group receiving the MOVE-IT HEP and a usual care treatment (UCT) group, as assessed by the Jebsen Tailor Hand Function Test (JTHFT), a time-based measure of functional hand motor skills, and other gold-standard clinical instruments for UE function including the Quality of Upper Extremity Skills Test (QUEST), with qualitative assessment of discrete movements, and the Wolf Motor Function Test (WMFT), which includes both quantitative and qualitative assessment of functional movements.\n\nThe pre-to-post intervention change in the composite JTHFT score will be the primary endpoint for the Phase II efficacy study. Secondary analysis will include pre-to-post intervention changes in the composite QUEST and WMFT scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of hemiplegia resulting from cerebral palsy, stroke, or other form of brain injury;\n* Medically stable;\n* Participant has antigravity strength in the affected UE at the elbow to at least 45 degrees of active flexion;\n* Participant has antigravity shoulder strength in the affected UE to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active internal/external rotation when in an upright and seated position;\n* Participant has ability to perform a basic color-matching test and identify characters on a vision chart;\n* Participant must be available to attend study visits during an approximately 3-week participation period;\n* Willingness and ability to comply with scheduled visits and study procedures.\n\nExclusion Criteria:\n\n* History of uncontrolled seizures;\n* Has received another form of intensive UE therapy, such as CIMT, within the prior 6 months;\n* Unwillingness or inability to understand or follow verbal directions;\n* Diagnosis of moderate to severe cortical-visual impairment that in the judgement of the Principal Investigator could adversely impact the subject's participation;\n* Psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation;\n* Determination that participation would result in over exertion, or significant discomfort or pain;\n* Determination that participation would result in significant agitation or elevated stress;\n* Visual field deficit in either eye that impairs the ability to view the computer monitor."}, 'identificationModule': {'nctId': 'NCT04510857', 'acronym': 'MOVE-IT', 'briefTitle': 'Motivating Occupational Virtual Experiences In Therapy for Kids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Barron Associates, Inc.'}, 'officialTitle': 'Motivating Occupational Virtual Experiences In Therapy for Kids (MOVE-IT)', 'orgStudyIdInfo': {'id': 'MOVE-IT'}, 'secondaryIdInfos': [{'id': '5R44HD092169-03', 'link': 'https://reporter.nih.gov/quickSearch/5R44HD092169-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MOVE-IT Home Exercise Program (HEP)', 'description': 'Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period.', 'interventionNames': ['Device: MOVE-IT Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care Treatment (UCT) Control', 'description': 'Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants.', 'interventionNames': ['Behavioral: UCT Control']}], 'interventions': [{'name': 'MOVE-IT Intervention', 'type': 'DEVICE', 'description': 'The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand.', 'armGroupLabels': ['MOVE-IT Home Exercise Program (HEP)']}, {'name': 'UCT Control', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services.', 'armGroupLabels': ['Usual Care Treatment (UCT) Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia (UVA)', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barron Associates, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Virginia', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}