Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 5:52 PM
Study NCT ID:
NCT02417532
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2015-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nickbirch@doctors.org.uk', 'phone': '+44 1604 215440', 'title': 'Nick Birch', 'organization': 'The Chris Moody Centre'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Patients enrolled under at different times in the recruitment process had differing lengths of follow-up as reflected in the final study report.'}}, 'adverseEventsModule': {'timeFrame': '7 days', 'eventGroups': [{'id': 'EG000', 'title': 'Rehabilitation Using REX', 'description': 'All patients who were able to transfer into a Rex with or without assistance.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 0, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ability to Transfer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation Using REX', 'description': 'Tetraplegic and paraplegic patients'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects meeting inclusion criteria. Physically able to properly fit in REX.'}, {'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation Using REX', 'description': 'Exercises using Rex mobility assist device\n\nRehabilitation using REX: Exercises of wheelchair dependent subjects using REX'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'absence of unexpected serious adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients transferring into Rex.'}, {'type': 'PRIMARY', 'title': 'Transfer Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation Using REX', 'description': 'Tetraplegic and paraplegic patients'}], 'classes': [{'categories': [{'measurements': [{'value': '352.2', 'spread': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 day', 'description': 'Time it took for participant to transfer into the Rex with or without supervision.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients transferring into Rex'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation Using REX', 'description': 'Tetraplegic and paraplegic patients who could control REX'}], 'classes': [{'title': 'Easy to Transfer % positive', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Confidence % positive', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Safety % positive', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Stability % positive', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Ease of control % positive', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'Comfort % positive', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'Wellbeing following use % positive', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Benefits to using regularly % positive', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'The size of REX did not bother me', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'The sound of REX did not bother me % positive', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'The speed of REX was suitable for me % positive', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Day', 'description': 'overall user satisfaction with the device', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were able to transfer into REX and who could control the joystick. One patient was unable to walk and control Rex so did not complete the questionaire.'}, {'type': 'SECONDARY', 'title': 'Timed up and go Test- Ability to Stand From Chair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rehabilitation Using REX', 'description': 'Exercises using Rex mobility assist device\n\nRehabilitation using REX: Exercises of wheelchair dependent subjects using REX'}], 'classes': [{'categories': [{'measurements': [{'value': '316.41', 'spread': '91.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 Day', 'description': 'The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test)', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who were able to control the joystick. One patient was unable to control the joystick and was excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rex Rehabilitation Patients', 'description': 'Tetraplegic and paraplegic patients able to use REX.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rehabilitation Using REX', 'description': 'Exercises using Rex mobility assist device\n\nRehabilitation using REX: Exercises of wheelchair dependent subjects using REX'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age - from date of birth record', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.8', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-18', 'studyFirstSubmitDate': '2015-04-11', 'resultsFirstSubmitDate': '2016-12-26', 'studyFirstSubmitQcDate': '2015-04-14', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-26', 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to Transfer', 'timeFrame': '1 day', 'description': 'Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX'}, {'measure': 'Adverse Events', 'timeFrame': '1 day', 'description': 'absence of unexpected serious adverse events'}, {'measure': 'Transfer Time', 'timeFrame': '1 day', 'description': 'Time it took for participant to transfer into the Rex with or without supervision.'}], 'secondaryOutcomes': [{'measure': 'Participant Satisfaction Questionnaire', 'timeFrame': '1 Day', 'description': 'overall user satisfaction with the device'}, {'measure': 'Timed up and go Test- Ability to Stand From Chair', 'timeFrame': '1 Day', 'description': 'The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '28629390', 'type': 'DERIVED', 'citation': 'Birch N, Graham J, Priestley T, Heywood C, Sakel M, Gall A, Nunn A, Signal N. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J Neuroeng Rehabil. 2017 Jun 19;14(1):60. doi: 10.1186/s12984-017-0274-6.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation.', 'detailedDescription': 'The objective of this feasibility study is to evaluate the overall device safety when used in Spinal Cord Injury Hospitals or Rehabilitation Centers under the supervision of a physician and/or qualified rehabilitation specialists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Wheelchair user\n* Spinal Injury Levels of C4 down to L5\n* Has no outstanding skin integrity issues that could be effected by the REX device\n* Should be between approximately 1.42m and 1.93m in height. More specifically, REX is able to accommodate the following limb lengths:\n* Upper leg length : 380 - 470 mm\n* Lower leg length : 366 - 470 mm\n* Heel position (Ankle to hind foot) : 40 - 92 mm\n* Floor to ankle height (To be measured while wearing the shoe to be used for mobilising in REX) : 96 - 116 mm\n* Has a skeletal hip width of 380 mm or less (limit imposed by REX)\n* Is between 40 kg and 100 kg weight (limits imposed by REX)\n* Has the manual dexterity to work a joystick\n* Sufficient passive range of motion in the Hip, Knee and Ankle of at least\n* Hip 90 degrees flexion 15 degrees hip extension 20 degrees abduction 16 degrees adduction\n* Knee 0 degrees extension 93 degrees flexion\n* Ankle 20 degrees dorsiflexion (with weight bearing and 10 degrees knee flexion) 22 degrees dorsiflexion (with 93 degrees knee flexion) 10 degrees plantar flexion 9 degrees inversion 9 degrees eversion\n* Thigh lateral diameter of \\< 135 mm (230 mm above the knee joint line)\n* Calf lateral diameter of \\< 100 mm (90 mm below the knee joint line)\n* Manual dexterity to work a joystick with or without a T-Bar and use emergency stop button\n* No contraindications to standing or mobilising\n* Patients must choose to participate, and must have signed the informed consent document\n\nExclusion Criteria:\n\n* Patients who do not meet inclusion criteria or physician discretion.\n* Patients with history of impaired cardiac function who have been referred to and reviewed by a medical professional. With a decision made that they should not continue in the trial due to their impaired cardiac function.\n* Patients contraindicated to walk or stand\n* Patients with spinal injury outside Inclusion criteria\n* Withdrawal or refusal to sign informed consent\n* Any other contraindication based on physician discretion\n* Known allergy (skin contact) to materials used in Rex'}, 'identificationModule': {'nctId': 'NCT02417532', 'acronym': 'RAPPER II', 'briefTitle': 'Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rex Bionics Plc'}, 'officialTitle': 'Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX', 'orgStudyIdInfo': {'id': 'RXPR-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation using REX', 'description': 'Exercises using Rex mobility assist device', 'interventionNames': ['Device: Rehabilitation using REX']}], 'interventions': [{'name': 'Rehabilitation using REX', 'type': 'DEVICE', 'description': 'Exercises of wheelchair dependent subjects using REX', 'armGroupLabels': ['Rehabilitation using REX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '1010', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Rehabilitation Innovation Centre at AUT University', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '4708', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Canterbury District Health Board, Burwood Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': 'CT1 3NG', 'city': 'Canterbury', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'East Kent Hospitals University Foundation Trust', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'zip': 'WD6 4QY', 'city': 'Stanmore', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Royal National Orthopaedic Hospital NHS Trust', 'geoPoint': {'lat': 51.61667, 'lon': -0.31667}}, {'zip': 'NN37rr', 'city': 'Moulton', 'state': 'Northamptonshire', 'country': 'United Kingdom', 'facility': 'Physiofunction', 'geoPoint': {'lat': 52.2524, 'lon': 0.48288}}], 'overallOfficials': [{'name': 'Nicholas C Birch, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Chris Moody Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rex Bionics Plc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Generic Devices Consulting, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}