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

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ClinicalTrials.gov Identifier: NCT00552916
Recruitment Status : Unknown
Verified August 2008 by Toronto Rehabilitation Institute.
Recruitment status was:  Recruiting
First Posted : November 2, 2007
Last Update Posted : August 20, 2008
Heart and Stroke Foundation of Ontario
Information provided by:
Toronto Rehabilitation Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Device: Compex Motion Stimulator Phase 4

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Functional Electrical Stimulation (FES)-Assisted Walking: Enhancement of Voluntary Walking Function Among Persons With Severe Hemiplegia Post-Stroke
Study Start Date : October 2007
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
'False' FES
The intervention group will receive 'true' FES
Device: Compex Motion Stimulator
'True' Functional Electrical Stimulation Assisted Walking

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry [ Time Frame: Baseline, 2-month and 6-month ]
  3. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552916

Contact: Naaz Kapadia, MSc 416-597-3422 ext 6310 kapadia.naaz@torontorehab.on.ca

Canada, Ontario
Toronto Rehabilitation Institute: Lyndhurst Centre Recruiting
Toronto, Ontario, Canada, M4G 3V9
Contact: Naaz Kapadia, MSc    416-597-3422 ext 6310    kapadia.naaz@torontorehab.on.ca   
Contact: Milos R Popovic, PhD       milos.popovic@utoronto.ca   
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         
Sponsors and Collaborators
Toronto Rehabilitation Institute
Heart and Stroke Foundation of Ontario
Principal Investigator: Milos R Popovic, PhD University of Toronto

Responsible Party: Dr. Milos R. Popovic, Toronto Rehab: Lyndhurst Centre
ClinicalTrials.gov Identifier: NCT00552916     History of Changes
Obsolete Identifiers: NCT00538837
Other Study ID Numbers: SRA 5973
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: August 20, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases