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

NCT ID: NCT00201968

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2013-04-30

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.

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FES training

Arm 1 receives functional electrical stimulation while walking on body weight suspension training.

Group Type: OTHER

Compex Motion Stimulator

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Control Group training

Aerobic and resistance training program

Group Type: OTHER

Conventional Exercise

Intervention Type: OTHER

An aerobic and resistance training program.

Interventions

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

Intervention Type: DEVICE

Compex Motion Stimulator

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

Intervention Type: DEVICE

Conventional Exercise

An aerobic and resistance training program.

Intervention Type: OTHER

Other Intervention Names

Brand Name: Loko 70; Code Names: BWST, FES; FES, Electrical stimulation; Conventional Physiotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Neurotrauma Foundation

OTHER

Sponsor Role: lead

Responsible Party

Milos Popovic

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Milos Popovic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Lyndhurst Centre, Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25229735 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23031172 (View on PubMed)

Other Identifiers

REL-2004-3

Identifier Type: -

Identifier Source: org_study_id