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

NCT ID: NCT00552916

Last Updated: 2008-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type OTHER

Compex Motion Stimulator

Intervention Type DEVICE

'False' FES

2

The intervention group will receive 'true' FES

Group Type OTHER

Compex Motion Stimulator

Intervention Type DEVICE

'True' Functional Electrical Stimulation Assisted Walking

Interventions

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Compex Motion Stimulator

'True' Functional Electrical Stimulation Assisted Walking

Intervention Type DEVICE

Compex Motion Stimulator

'False' FES

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role collaborator

Toronto Rehabilitation Institute

OTHER

Sponsor Role lead

Responsible Party

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Toronto Rehab: Lyndhurst Centre

Principal Investigators

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Milos R Popovic, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Toronto Rehabilitation Institute: Lyndhurst Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Naaz Kapadia, MSc

Role: CONTACT

Phone: 416-597-3422

Email: [email protected]

Facility Contacts

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Naaz Kapadia, MSc

Role: primary

Milos R Popovic, PhD

Role: backup

Other Identifiers

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SRA 5973

Identifier Type: -

Identifier Source: org_study_id

NCT00538837

Identifier Type: -

Identifier Source: nct_alias