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Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201968
Recruitment Status : Unknown
Verified February 2013 by Milos Popovic, Toronto Rehabilitation Institute.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : February 27, 2013
Information provided by (Responsible Party):
Milos Popovic, Toronto Rehabilitation Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Compex Motion Stimulator Other: Conventional Exercise Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
Study Start Date : April 2005
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
FES training
Arm 1 receives functional electrical stimulation while walking on body weight suspension training.
Device: Compex Motion Stimulator
Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill
Other Names:
  • Brand Name: Loko 70
  • Code Names: BWST, FES

Device: Compex Motion Stimulator
Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.
Other Name: FES, Electrical stimulation

Control Group training
Aerobic and resistance training program
Other: Conventional Exercise
An aerobic and resistance training program.
Other Name: Conventional Physiotherapy

Primary Outcome Measures :
  1. Whole body muscle mass via dual-energy x-ray absorptiometry [ Time Frame: Baseline, 4 month and 12 months ]
  2. Bone density at different hip, spine, proximal and distal femur and proximal Tibia using dual-energy xray absorptiometry [ Time Frame: Baseline, 4 month and 12 months ]
  3. Bone density, bone geometry and muscle area via computed tomography, [ Time Frame: Baseline, 4 month and 12 months ]
  4. Spasticity via Ashworth Scale and Pendulum Test, and [ Time Frame: Baseline, 4 months, 6 months and 12 months ]
  5. Factor analysis of electromyography and kinematics of gait. [ Time Frame: Baseline, 4months and 6 months ]

Secondary Outcome Measures :
  1. Incidence of urinary tract infections, [ Time Frame: Over 12 months ]
  2. Spinal cord independence measure, [ Time Frame: Baseline and 12 months ]
  3. Urinary N-telopeptide and serum osteocalcin, [ Time Frame: Baseline, 4 month, 6 month and 12 months ]
  4. Timed up and go and two-minute walk test (functional mobility), [ Time Frame: Baseline, 4 months, 6 months and 12 months ]
  5. Incidence of pressure sores, [ Time Frame: Over 12 months ]
  6. Reintegration to normal living index, [ Time Frame: Baseline, 4, 6 and 12 months ]
  7. Satisfaction with life scale, [ Time Frame: Baseline, 4 , 6 and 12 months ]
  8. Instrumental Activities of Daily Living SubScale, [ Time Frame: Baseline, 4, 6 and 12 months ]
  9. Craig Handicap assessment and reporting technique, and [ Time Frame: Baseline, 4, 6 and 12 months ]
  10. client perception of treatment (qualitative). [ Time Frame: At 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • contraindications for FES, such as cardiac pacemakers, skin lesions or rush at potential electrode sites, or denervation of targeted muscles.
  • pressure ulcers anywhere on the lower extremities
  • hypertension that is uncontrolled
  • symptoms of orthostatic hypotension when standing for 15 minutes
  • susceptibility to autonomic dysreflexia, requiring medication.
  • if there is a history of cardiovascular disease, participants must obtain medical clearance from their physician before inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201968

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Canada, Ontario
Lyndhurst Centre, Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M4G 3V9
Sponsors and Collaborators
Ontario Neurotrauma Foundation
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Principal Investigator: Milos Popovic, PhD University of Toronto
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Milos Popovic, Senior Scientist, Toronto Rehabilitation Institute Identifier: NCT00201968    
Other Study ID Numbers: REL-2004-3
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System