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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Toronto Rehabilitation Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00552916
First received: November 1, 2007
Last updated: August 19, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Stroke
Device: Compex Motion Stimulator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Functional Electrical Stimulation (FES)-Assisted Walking: Enhancement of Voluntary Walking Function Among Persons With Severe Hemiplegia Post-Stroke

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • 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:
  • 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. ]
  • Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry [ Time Frame: 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. ]

Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
'False' FES
2
The intervention group will receive 'true' FES
Device: Compex Motion Stimulator
'True' Functional Electrical Stimulation Assisted Walking

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.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552916

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

Locations
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
Investigators
Principal Investigator: Milos R Popovic, PhD University of Toronto
  More Information

No publications provided

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
Study First Received: November 1, 2007
Last Updated: August 19, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014