Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-01-13 @ 9:30 AM
Study NCT ID:
NCT01740128
Status:
COMPLETED
Last Update Posted:
2018-02-26
First Post:
2012-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multimodal Exercises to Improve Leg Function After Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D010264', 'term': 'Paraplegia'}, {'id': 'D020335', 'term': 'Paraparesis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010291', 'term': 'Paresis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'noam.harel@va.gov', 'phone': '718-584-9000', 'title': 'Noam Y. Harel, MD, PhD', 'phoneExt': '1742', 'organization': 'James J. Peters VAMC'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Smaller than expected enrollment, high dropout rate.'}}, 'adverseEventsModule': {'timeFrame': 'Approx. 6 months or until completion of study participation.', 'description': 'No serious adverse events. Several minor skin abrasions.', 'eventGroups': [{'id': 'EG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.', 'otherNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.75', 'groupId': 'OG000'}, {'value': '-2.01', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.', 'unitOfMeasure': 'Amplitude percentage of Mmax', 'reportingStatus': 'POSTED', 'populationDescription': 'Only two participants in the study had consistent MEPs at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in ISNCSCI Lower Extremity Motor Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '4.81', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '4.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in lower extremity motor score derived from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Range of scores 0-50, higher is better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject in multimodal group failed to appear for post-intervention testing for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Incomplete analysis due to dropouts before post-testing'}, {'type': 'SECONDARY', 'title': 'Change in Leg Spasticity on Modified Ashworth Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.'}, {'type': 'SECONDARY', 'title': 'Change in Gait Speed on 10-meter Walk Test.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '.04', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.132', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.', 'unitOfMeasure': 'meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Insufficient number of participants able to walk at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.', 'reportingStatus': 'POSTED', 'populationDescription': 'Insufficient number of participants able to walk at baseline. Measure not recorded by Investigating team.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in steps taken during 10-second step test.', 'unitOfMeasure': 'steps', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Low number of participants able to perform seated steps at baseline.'}, {'type': 'SECONDARY', 'title': 'Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '-0.93', 'spread': '3.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.93', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '8.42', 'spread': '4.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Seated posturography performed using the "Limits of Stability" module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure.', 'unitOfMeasure': 'Percentage of perfect path to target', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Incomplete analysis due to dropouts before post-testing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Soleus H-reflex Facilitation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.63', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '-5.20', 'spread': '3.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.', 'unitOfMeasure': 'percentage of control reflex size', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Incomplete analysis due to dropouts before post-testing, and due to lack of soleus H-reflex in several subjects.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimodal Training', 'description': 'Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'OG001', 'title': 'Treadmill Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.14', 'spread': '11.44', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multimodal Then Treadmill Training', 'description': 'Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'FG001', 'title': 'Treadmill Then Multimodal Training', 'description': 'Participants will undergo body weight supported treadmill training using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Insufficient protocol compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Multimodal Then Treadmill Training', 'description': 'Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'BG001', 'title': 'Treadmill Then Multimodal Training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.\n\nMultimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.\n\nRobotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', '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': '1', 'groupId': 'BG001'}, {'value': '1', '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': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-26', 'studyFirstSubmitDate': '2012-11-30', 'resultsFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-26', 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in ISNCSCI Lower Extremity Motor Score.', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in lower extremity motor score derived from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Range of scores 0-50, higher is better.'}, {'measure': 'Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.'}, {'measure': 'Change in Leg Spasticity on Modified Ashworth Scale', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.'}, {'measure': 'Change in Gait Speed on 10-meter Walk Test.', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.'}, {'measure': 'Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale.', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.'}, {'measure': 'Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in steps taken during 10-second step test.'}, {'measure': 'Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.'}, {'measure': 'Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.', 'timeFrame': 'Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Seated posturography performed using the "Limits of Stability" module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure.'}, {'measure': 'Change From Baseline in Soleus H-reflex Facilitation.', 'timeFrame': 'Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.'}, {'measure': 'Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)', 'timeFrame': 'Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)', 'description': 'Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['spinal cord injuries', 'paraplegia', 'postural balance', 'locomotor activity', 'exercise therapy', 'electromyography', 'transcranial magnetic stimulation, single pulse'], 'conditions': ['Spinal Cord Injuries', 'Paraplegia', 'Paraparesis']}, 'referencesModule': {'references': [{'pmid': '23809527', 'type': 'BACKGROUND', 'citation': 'Harel NY, Asselin PK, Fineberg DB, Pisano TJ, Bauman WA, Spungen AM. Adaptation of computerized posturography to assess seated balance in persons with spinal cord injury. J Spinal Cord Med. 2013 Mar;36(2):127-33. doi: 10.1179/2045772312Y.0000000053.'}, {'pmid': '25771437', 'type': 'BACKGROUND', 'citation': 'Harel NY, Martinez SA, Knezevic S, Asselin PK, Spungen AM. Acute changes in soleus H-reflex facilitation and central motor conduction after targeted physical exercises. J Electromyogr Kinesiol. 2015 Jun;25(3):438-43. doi: 10.1016/j.jelekin.2015.02.009. Epub 2015 Mar 2.'}]}, 'descriptionModule': {'briefSummary': "Many people with spinal cord injury (SCI) retain at least some movement below their injury, but their muscles often have a 'mind of their own'. Typical exercise programs focus on keeping muscles strong and flexible, but don't usually focus on helping patients control their muscles. The investigators' exercise research study will compare two different programs with the specific goal of improving conscious control of patients' muscles below the injury. This study focuses on those with 'chronic' SCI - the injury occurred at least one year prior to enrolling.\n\nThis is a single center study taking place in the Bronx, NY.\n\nThe first phase of the study will be observational - the investigators will analyze which nerve connections might remain partially intact through the injury (even if the nerves aren't consciously controlled). Participants with all severity of SCI may participate in this first phase.\n\nThe second phase of the study will involve people who retain at least slight ability to move their legs and the ability to move the arms against gravity. Each person will undergo two different exercise rehabilitation strategies: weight-supported treadmill training; and balance training combined with skilled arm or hand exercises.\n\nThe investigators will compare the effects of these exercise programs on a variety of outcomes, including gait speed, balance, strength, and muscle activation in response to brain stimulation.\n\nThe investigators hypothesize that participants with chronic SCI undergoing combined balance/arm/hand training will show improved outcomes when compared to traditional gait or balance training."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females age 21-65 years;\n* SCI duration \\> 12 months;\n* SCI level C2-T12;\n* All SCI severity eligible for baseline testing;\n* For exercise protocol, must have severity of Grade C or D on American Spinal Injury Association (ASIA) Impairment Scale, or volitional strength of at least 1/5 in two or more key lower extremity muscles, as well as at least 3/5 in both shoulder and elbow muscles;\n* Able to tolerate upright position with support;\n* Morphologically capable of fitting a weight-support harness and robotic treadmill system;\n* Ability to give informed consent.\n\nExclusion Criteria:\n\n* Unsuitable cognitive capacity as judged by the study physician;\n* Diagnosis of neurological injury other than SCI, such as stroke, traumatic brain injury, or other neurological condition that the study physician considers to be exclusionary;\n* Multiple spinal cord lesions;\n* History of frequent autonomic dysreflexia;\n* History of seizures;\n* Use of medications that significantly lower seizure threshold, such as anti-psychotics, tricyclic antidepressants, amphetamines, and bupropion;\n* History of implanted brain/spine/nerve stimulators, aneurysm clips, or cardiac pacemaker/defibrillator;\n* Deep vein thrombosis in lower extremities of less than 6 months duration;\n* Pregnancy;\n* (Interventional phase only): Lack of detectable tibialis anterior motor evoked potential (MEP) at baseline even with active facilitation;\n* (Interventional phase only): Pressure ulcers greater than stage 1 severity on the foot, ankle, knee and/or pelvic girdle;\n* (Interventional phase only): Bone mineral density of the hip (proximal femur) T-score \\<3.5 standard deviations from age- and gender-matched normative data;\n* (Interventional phase only): Any spasticity, contractures, or heterotopic ossification that result in inadequate range of motion of the shoulder, elbow, wrist, fingers, hip, knee, or ankle joints in the judgment of the study physician;\n* (Interventional phase only): Inability to cooperate with instructions or unwilling to commit to daily training sessions for 3-4 days per week over 12-16 weeks;\n* (Interventional phase only): A diagnosis of coronary artery disease that precludes moderate to intense exercise.'}, 'identificationModule': {'nctId': 'NCT01740128', 'briefTitle': 'Multimodal Exercises to Improve Leg Function After Spinal Cord Injury', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'A Hebbian Approach to Regaining Control of Spared Circuits in Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'B0881-W'}, 'secondaryIdInfos': [{'id': '5IK2RX000881-03', 'link': 'https://reporter.nih.gov/quickSearch/5IK2RX000881-03', 'type': 'NIH'}, {'id': '01407', 'type': 'OTHER', 'domain': 'Bronx VA Medical Center'}, {'id': 'SPU-11-077', 'type': 'OTHER', 'domain': 'Bronx VA Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal then Treadmill training', 'description': 'Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.', 'interventionNames': ['Device: Robotic body weight supported treadmill training', 'Other: Harness-supported multimodal balance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treadmill then Multimodal training', 'description': 'Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.', 'interventionNames': ['Device: Robotic body weight supported treadmill training', 'Other: Harness-supported multimodal balance training']}], 'interventions': [{'name': 'Robotic body weight supported treadmill training', 'type': 'DEVICE', 'otherNames': ['Lokomat'], 'description': '30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.', 'armGroupLabels': ['Multimodal then Treadmill training', 'Treadmill then Multimodal training']}, {'name': 'Harness-supported multimodal balance training', 'type': 'OTHER', 'otherNames': ['balance exercises, skilled hand exercises'], 'description': '30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.', 'armGroupLabels': ['Multimodal then Treadmill training', 'Treadmill then Multimodal training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'James J. Peters VA Medical Center, Bronx, NY', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Noam Y Harel, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'James J. Peters Veterans Affairs Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'A Limited Dataset (LDS) will be shared in electronic format pursuant to a VA-approved Data Use Agreement. Individually Identifiable Data will be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate written agreement limiting use of the data to the conditions as described in the authorization and consent, and a written assurance from the recipient that the information will be maintained in accordance with the security requirements of 38 CFR Part 1.466.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}