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

Phase

Condition

Spinal Cord Disorders

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT00201968

REL-2004-3

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

incomplete spinal cord lesion of sudden onset between C6 and T12 that is motorincomplete (grade C or D on the ASIA neurological impairment scale). The injury musthave occurred at least two years prior to recruitment

Exclusion

Exclusion Criteria:

contraindications for FES, such as cardiac pacemakers, skin lesions or rush atpotential 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 medicalclearance from their physician before inclusion

Study Design

April 01, 2005

April 30, 2013

Study 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.

Connect with a study center

Lyndhurst Centre, Toronto Rehabilitation Institute
Toronto, Ontario M4G 3V9
Canada
Site Not Available

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