Functional Electrical Stimulation (FES) Assisted Walking: Enhancement of Walking Function After Stroke

August 19, 2008 updated by: Toronto Rehabilitation Institute

Functional Electrical Stimulation (FES)-Assisted Walking: Enhancement of Voluntary Walking Function Among Persons With Severe Hemiplegia Post-Stroke

The purpose of this study is to determine if a form of exercise,known as electrical stimulation can improve walking function and other important health outcomes. The hypothesis is that electrical stimulation can enhance the ability to walk for stroke survivors who are unable to walk on their on their own.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A stroke is a devastating life event, that can result in permanent disability. Many people who survive a stroke will experience paralysis on one side of their body. The muscles in one leg may become weaker or stiff to the point that the person can barely walk. Functional electrical stimulation (FES) is an intervention that applies short current pulses to muscles and causes them to contract. Previous work done by our team has used FES in the spinal cord injured population to help restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner. This study seeks to explore whether a thrice weekly FES-assisted walking intervention for a 8 week period can stimulate or improve walking ability in individuals with severe lower extremity paralysis secondary to a stroke. This will subsequently promote opportunities for enhanced social participation and quality of life i.e. enhanced balance, increased independence of activities of daily living etc. for stroke consumers. Comparison: 40 individuals with severe hemiplegia will be randomized to either a thrice weekly control (false) FES training regimen OR a thrice weekly intervention (true) FES training regimen. Prior to randomization, participants will be stratified according to their ability to ambulate (walk). This study will determine if FES can improve or enhance walking ability associated with stroke after 8 weeks of training, and after 4-month follow-up period.

Study Type

Interventional

Enrollment (Anticipated)

40

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 Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 3V9
        • Recruiting
        • Toronto Rehabilitation Institute: Lyndhurst Centre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Molly Verrier, M.H.Sc., Dip(P&OT)
        • Sub-Investigator:
          • Denyse Richardson, MD
        • Sub-Investigator:
          • Lora Giangregorio, PhD
        • Sub-Investigator:
          • Lehana Thabane, PhD
        • Sub-Investigator:
          • Nancy Salbach, PhD

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

No older than 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hemiplegic stroke at least 12 months prior to joining the study.
  • Age 65 years or greater.
  • Ability to follow instructions and to devote his/her attention to therapy.
  • Ability to understand instructions in English and able to provide informed consent.

Exclusion Criteria:

  • Severe difficulties with attention such that informed consent cannot be obtained, or that safety or communication would be comprised.
  • Ability to walk more that 10 meters during a two minute walk with an average speed greater than 0.8 m/s.
  • The presence of skin rashes, allergies or bruises where electrodes would be placed.
  • History of seizures, edema in paralyzed limbs or co-morbidities such as Parkinson's Disease, cancer or osteoarthritis to be confirmed by attending physiatrist.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Participants will be randomized to either an intervention arm where they will receive 'true' FES and the other control arm where they will receive 'false' FES. The sham group will receive 'false' FES.
Device: Compex Motion Stimulator
'True' Functional Electrical Stimulation Assisted Walking
Device: Compex Motion Stimulator
'False' FES
Other: 2
The intervention group will receive 'true' FES
Device: Compex Motion Stimulator
'True' Functional Electrical Stimulation Assisted Walking
Device: Compex Motion Stimulator
'False' FES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The ability of FES-Assisted Walking to stimulate or improve walking ability using a dichotomous outcome i.e. yes/no stimulation or improvement of walking ability on a two-minute walk test.
Time Frame: Test performed weekly during 8-week period as well as at 2 month and 6 month time point.
Test performed weekly during 8-week period as well as at 2 month and 6 month time point.

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of balance by completing four tests i.e. move from a seated to a standing position, completion of activities of daily living tasks such as moving from a bed to a wheelchair, standing with eyes opened and closed.
Time Frame: Baseline, 2 month and 6 month period.
Baseline, 2 month and 6 month period.
Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry
Time Frame: Baseline, 2-month and 6-month
Baseline, 2-month and 6-month
Assess functional abilities by performing various tasks using our leg and foot as well as your ability to perform functional tasks such as eating, grooming and bathing.
Time Frame: Baseline, 2-month and 6-month time points.
Baseline, 2-month and 6-month time points.

Collaborators and Investigators

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

Sponsor

Toronto Rehabilitation Institute

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

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

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

October 1, 2007

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

November 1, 2007

First Submitted That Met QC Criteria

November 1, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

August 20, 2008

Last Update Submitted That Met QC Criteria

August 19, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRA 5973

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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