This trial is active, not recruiting.

Condition spinal cord injury
Treatments compex motion stimulator, conventional exercise
Phase phase 4
Sponsor Ontario Neurotrauma Foundation
Start date April 2005
End date April 2013
Trial size 32 participants
Trial identifier NCT00201968, REL-2004-3


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm 1 receives functional electrical stimulation while walking on body weight suspension training.
compex motion stimulator Brand Name: Loko 70
Functional Electrical Stimulation applied to the lower limbs of SCI individuals in order to stimulate walking while on Body Weight Support Treadmill
compex motion stimulator FES, Electrical stimulation
Specific functional electrical stimulation program developed for each individual applied while walking on the treadmill.
Aerobic and resistance training program
conventional exercise Conventional Physiotherapy
An aerobic and resistance training program.

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,
time frame: Baseline, 4, 6 and 12 months
Satisfaction with life scale,
time frame: Baseline, 4 , 6 and 12 months
Instrumental Activities of Daily Living SubScale,
time frame: Baseline, 4, 6 and 12 months
Craig Handicap assessment and reporting technique, and
time frame: Baseline, 4, 6 and 12 months
client perception of treatment (qualitative).
time frame: At 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Functional Electrical Stimulation-Assisted Walking: Reduction of Secondary Complications Due to Spinal Cord Injury
Principal investigator Milos Popovic, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Ontario Neurotrauma Foundation.