Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-05 @ 6:10 PM
Study NCT ID:
NCT00201968
Status:
UNKNOWN
Last Update Posted:
2013-02-27
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
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': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-25', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole body muscle mass via dual-energy x-ray absorptiometry', 'timeFrame': 'Baseline, 4 month and 12 months'}, {'measure': 'Bone density at different hip, spine, proximal and distal femur and proximal Tibia using dual-energy xray absorptiometry', 'timeFrame': 'Baseline, 4 month and 12 months'}, {'measure': 'Bone density, bone geometry and muscle area via computed tomography,', 'timeFrame': 'Baseline, 4 month and 12 months'}, {'measure': 'Spasticity via Ashworth Scale and Pendulum Test, and', 'timeFrame': 'Baseline, 4 months, 6 months and 12 months'}, {'measure': 'Factor analysis of electromyography and kinematics of gait.', 'timeFrame': 'Baseline, 4months and 6 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of urinary tract infections,', 'timeFrame': 'Over 12 months'}, {'measure': 'Spinal cord independence measure,', 'timeFrame': 'Baseline and 12 months'}, {'measure': 'Urinary N-telopeptide and serum osteocalcin,', 'timeFrame': 'Baseline, 4 month, 6 month and 12 months'}, {'measure': 'Timed up and go and two-minute walk test (functional mobility),', 'timeFrame': 'Baseline, 4 months, 6 months and 12 months'}, {'measure': 'Incidence of pressure sores,', 'timeFrame': 'Over 12 months'}, {'measure': 'Reintegration to normal living index,', 'timeFrame': 'Baseline, 4, 6 and 12 months'}, {'measure': 'Satisfaction with life scale,', 'timeFrame': 'Baseline, 4 , 6 and 12 months'}, {'measure': 'Instrumental Activities of Daily Living SubScale,', 'timeFrame': 'Baseline, 4, 6 and 12 months'}, {'measure': 'Craig Handicap assessment and reporting technique, and', 'timeFrame': 'Baseline, 4, 6 and 12 months'}, {'measure': 'client perception of treatment (qualitative).', 'timeFrame': 'At 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '25229735', 'type': 'DERIVED', 'citation': 'Kapadia N, Masani K, Catharine Craven B, Giangregorio LM, Hitzig SL, Richards K, Popovic MR. A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency. J Spinal Cord Med. 2014 Sep;37(5):511-24. doi: 10.1179/2045772314Y.0000000263.'}, {'pmid': '23031172', 'type': 'DERIVED', 'citation': 'Giangregorio L, Craven C, Richards K, Kapadia N, Hitzig SL, Masani K, Popovic MR. A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: effects on body composition. J Spinal Cord Med. 2012 Sep;35(5):351-60. doi: 10.1179/2045772312Y.0000000041.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether an aerobic and resistance training program or a functional electrical stimulation-assisted Walking program is more effective for reducing health complications related to spinal cord injury, for example, the occurrence of bladder infections, pressure sores and/or frequency of spasms. It is hypothesized that the functional electrical stimulation-assisted walking will have a greater impact on secondary complications than the aerobic and resistance training program.', 'detailedDescription': 'A barrier to maintaining health status and active social participation in the community for individuals with spinal cord injury (SCI) is the broad number of secondary medical complications typically associated with their injury, such as bone loss, spasticity, urinary tract infections and pressure sores. Functional electrical stimulation (FES) is an intervention that applies short current pulses to muscles and causes them to contract. FES can be applied to individuals with SCI to help them restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner. Pilot work conducted by our research group suggests that applying FES to augment functional improvement often reduces incidents of secondary complications such as spasticity, pressure sores, and swelling of the legs. Specifically, functional and meaningful walking tasks performed on a regular basis with the help of FES therapy have the potential to improve overall physical and psychological well being of persons with incomplete SCI. This study seeks to demonstrate that thrice-weekly FES training for 4 months can restore/improve walking function in chronic, incomplete SCI individuals and that this therapy will considerably reduce the occurrences of secondary complications due to SCI. This will subsequently promote opportunities for active social participation and enhance the quality of life for SCI consumers. Comparison: 32 individuals with chronic, incomplete SCI will be randomized to either thrice-weekly FES therapy OR thrice-weekly aerobic and resistance training. The study will determine which therapy is superior for improving walking function and reducing secondary complications associated with SCI after 4 months of training, and after 2-month and 8-month follow-up periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* incomplete spinal cord lesion of sudden onset between C6 and T12 that is motor incomplete (grade C or D on the ASIA neurological impairment scale). The injury must have occurred at least two years prior to recruitment\n\nExclusion Criteria:\n\n* contraindications for FES, such as cardiac pacemakers, skin lesions or rush at potential electrode sites, or denervation of targeted muscles.\n* pressure ulcers anywhere on the lower extremities\n* hypertension that is uncontrolled\n* symptoms of orthostatic hypotension when standing for 15 minutes\n* susceptibility to autonomic dysreflexia, requiring medication.\n* if there is a history of cardiovascular disease, participants must obtain medical clearance from their physician before inclusion'}, 'identificationModule': {'nctId': 'NCT00201968', 'briefTitle': 'Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Ontario Neurotrauma Foundation'}, 'officialTitle': 'Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'REL-2004-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FES training', 'description': 'Arm 1 receives functional electrical stimulation while walking on body weight suspension training.', 'interventionNames': ['Device: Compex Motion Stimulator']}, {'type': 'OTHER', 'label': 'Control Group training', 'description': 'Aerobic and resistance training program', 'interventionNames': ['Other: Conventional Exercise']}], 'interventions': [{'name': 'Compex Motion Stimulator', 'type': 'DEVICE', 'otherNames': ['Brand Name: Loko 70', 'Code Names: BWST, FES'], 'description': 'Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill', 'armGroupLabels': ['FES training']}, {'name': 'Compex Motion Stimulator', 'type': 'DEVICE', 'otherNames': ['FES, Electrical stimulation'], 'description': 'Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.', 'armGroupLabels': ['FES training']}, {'name': 'Conventional Exercise', 'type': 'OTHER', 'otherNames': ['Conventional Physiotherapy'], 'description': 'An aerobic and resistance training program.', 'armGroupLabels': ['Control Group training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4G 3V9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lyndhurst Centre, Toronto Rehabilitation Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Milos Popovic, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ontario Neurotrauma Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Milos Popovic', 'investigatorAffiliation': 'Toronto Rehabilitation Institute'}}}}