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

Phase 4UnknownNCT00201968

Ontario Neurotrauma Foundation32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Conditions

Spinal Cord Injury

Interventions

Compex Motion StimulatorDEVICE

Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill

Compex Motion StimulatorDEVICE

Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.

Conventional ExerciseOTHER

An aerobic and resistance training program.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Lyndhurst Centre, Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Whole body muscle mass via dual-energy x-ray absorptiometry

Time frame: Baseline, 4 month and 12 months

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

Bone density, bone geometry and muscle area via computed tomography,

Time frame: Baseline, 4 month and 12 months

Spasticity via Ashworth Scale and Pendulum Test, and

Time frame: Baseline, 4 months, 6 months and 12 months

Factor analysis of electromyography and kinematics of gait.

Time frame: Baseline, 4months and 6 months

Secondary Outcomes

Incidence of urinary tract infections,

Time frame: Over 12 months

Spinal cord independence measure,

Time frame: Baseline and 12 months

Urinary N-telopeptide and serum osteocalcin,

Time frame: Baseline, 4 month, 6 month and 12 months

Timed up and go and two-minute walk test (functional mobility),

Time frame: Baseline, 4 months, 6 months and 12 months

Incidence of pressure sores,

Time frame: Over 12 months

Reintegration to normal living index,

Data from ClinicalTrials.gov

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