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

Stroke Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT00552916
• Study type: Interventional
• Source: Toronto Rehabilitation Institute
• Contact: Naaz Kapadia, MSc
• Phone: 416-597-3422
• Email: kapadia.naaz@torontorehab.on.ca
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2007
• Completion date: November 2010