Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-28 @ 2:20 AM
Study NCT ID:
NCT01943669
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2013-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exoskeletons for Spinal Cord Injury: A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067190', 'term': 'Exoskeleton Device'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2013-07-22', 'studyFirstSubmitQcDate': '2013-09-16', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stair management', 'timeFrame': '10 weeks', 'description': 'Exact timing pending learning curve, change in score in weeks up to 10 weeks.'}, {'measure': 'Obstacle course', 'timeFrame': '10 weeks', 'description': 'Exact timing pending learning curve, change in score in weeks up to 10 weeks.'}], 'primaryOutcomes': [{'measure': '10-meter walking test (10MWT)', 'timeFrame': '10 weeks', 'description': 'Change in score between 0 and 10 weeks.'}], 'secondaryOutcomes': [{'measure': '6-minutes walk test (6MWT)', 'timeFrame': '10 weeks', 'description': 'Change in score between 0 and 10 weeks.'}, {'measure': 'Timed Up and Go (TUG) test', 'timeFrame': '10 weeks', 'description': 'Change in score between 0 and 10 weeks.'}, {'measure': 'Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire', 'timeFrame': '10 weeks', 'description': 'Change in score between 0 and 10 weeks.'}, {'measure': 'Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire', 'timeFrame': '10 weeks', 'description': 'Change in score between 0 and 10 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal Cord Injury'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.smsf.org.uk/research%20introduction.htm', 'label': 'Website directing to project description and updates'}]}, 'descriptionModule': {'briefSummary': 'In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.', 'detailedDescription': 'In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Twenty one-hour training sessions are scheduled for each participant over a 10-week period. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B \\& C (Lower Extremity Motor Score \\<20)\n* Motor level of injury from Cervical level 7 to Lumbar level 1, according to ASIA guidelines\n* Male and non-pregnant, non-lactating female\n* Age 18-55 years old\n* At least 12 months after injury\n* Able to stand or maintain upright position with or without using a standing device (e.g., 'Easy stand')\n* Able to sit with hips and knees ≥90° flexion\n* Height of 160 to 190 cm\n* Weight of \\<100 kg\n\nExclusion Criteria:\n\n* History of severe neurological injuries other than spinal cord injury (eg. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)\n* Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study\n* Unstable spine or unhealed limbs or pelvic fractures\n* Limited range of motion (\\<90°) hip and knee joints, including severe contractures\n* Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus\n* Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.\n* Psychiatric or cognitive conditions that may interfere with the trial\n* Previous use of any exoskeletal robotic device\n* Patients incapable of providing informed consent"}, 'identificationModule': {'nctId': 'NCT01943669', 'briefTitle': 'Exoskeletons for Spinal Cord Injury: A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Buckinghamshire Healthcare NHS Trust'}, 'officialTitle': 'An Open, Longitudinal, Prospective, Non-randomized, Self-Controlled Feasibility Study to Investigate the Effect of the ReWalk™ Device on Mobility Outcomes in Patients With Chronic Spinal Cord Injury.', 'orgStudyIdInfo': {'id': '13/EE/0048 (UK NRES)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReWalk™ device', 'description': 'Self-controlled group; single cohort.', 'interventionNames': ['Device: ReWalk™ device']}], 'interventions': [{'name': 'ReWalk™ device', 'type': 'DEVICE', 'otherNames': ['Exoskeleton', 'Bionic suit'], 'description': 'Twenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period.', 'armGroupLabels': ['ReWalk™ device']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HP21 8AL', 'city': 'Aylesbury', 'state': 'Buckinghamshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Joost J. van Middendorp, MD, PhD', 'role': 'CONTACT', 'email': 'Joost.vanMiddendorp@buckshealthcare.nhs.uk', 'phone': '+44 1296316783'}, {'name': 'Joost J. van Middendorp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'I Benson, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'K Hart, BSc, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'D Tussler, BSc, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Spinal Injuries Centre, Stoke Mandeville Hospital', 'geoPoint': {'lat': 51.81665, 'lon': -0.81458}}], 'centralContacts': [{'name': 'Joost J. van Middendorp, MD, PhD', 'role': 'CONTACT', 'email': 'Joost.vanMiddendorp@buckshealthcare.nhs.uk', 'phone': '+44 1296 316783'}], 'overallOfficials': [{'name': 'Joost J. van Middendorp, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stoke Mandeville Spinal Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buckinghamshire Healthcare NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}