Clinical Trials Directory

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UnknownNCT00552916

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

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

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Toronto Rehabilitation Institute · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
DEVICECompex Motion Stimulator'True' Functional Electrical Stimulation Assisted Walking
DEVICECompex Motion Stimulator'False' FES

Timeline

Start date
2007-10-01
Primary completion
2010-10-01
Completion
2010-11-01
First posted
2007-11-02
Last updated
2008-08-20

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00552916. Inclusion in this directory is not an endorsement.