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

February 25, 2013 updated by: Milos Popovic, Ontario Neurotrauma Foundation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 3V9
        • Lyndhurst Centre, Toronto Rehabilitation Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • FES, Electrical stimulation
OTHER: Control Group training
Aerobic and resistance training program
Other: Conventional Exercise
An aerobic and resistance training program.
Other Names:
  • Conventional Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Whole body muscle mass via dual-energy x-ray absorptiometry
Time Frame: Baseline, 4 month and 12 months
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
Baseline, 4 month and 12 months
Bone density, bone geometry and muscle area via computed tomography,
Time Frame: Baseline, 4 month and 12 months
Baseline, 4 month and 12 months
Spasticity via Ashworth Scale and Pendulum Test, and
Time Frame: Baseline, 4 months, 6 months and 12 months
Baseline, 4 months, 6 months and 12 months
Factor analysis of electromyography and kinematics of gait.
Time Frame: Baseline, 4months and 6 months
Baseline, 4months and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of urinary tract infections,
Time Frame: Over 12 months
Over 12 months
Spinal cord independence measure,
Time Frame: Baseline and 12 months
Baseline and 12 months
Urinary N-telopeptide and serum osteocalcin,
Time Frame: Baseline, 4 month, 6 month and 12 months
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
Baseline, 4 months, 6 months and 12 months
Incidence of pressure sores,
Time Frame: Over 12 months
Over 12 months
Reintegration to normal living index,
Time Frame: Baseline, 4, 6 and 12 months
Baseline, 4, 6 and 12 months
Satisfaction with life scale,
Time Frame: Baseline, 4 , 6 and 12 months
Baseline, 4 , 6 and 12 months
Instrumental Activities of Daily Living SubScale,
Time Frame: Baseline, 4, 6 and 12 months
Baseline, 4, 6 and 12 months
Craig Handicap assessment and reporting technique, and
Time Frame: Baseline, 4, 6 and 12 months
Baseline, 4, 6 and 12 months
client perception of treatment (qualitative).
Time Frame: At 12 months
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Neurotrauma Foundation

Investigators

  • Principal Investigator: Milos Popovic, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ANTICIPATED)

April 1, 2013

Study Completion (ANTICIPATED)

April 1, 2013

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 25, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REL-2004-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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