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

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Compex Motion Stimulator
Compex Motion Stimulator
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toronto Rehabilitation Institute: Lyndhurst CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

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.

The intervention group will receive 'true' FES

Outcomes

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.

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.
Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry
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.

Full Information

First Posted
November 1, 2007
Last Updated
August 19, 2008
Sponsor
Toronto Rehabilitation Institute
Collaborators
Heart and Stroke Foundation of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00552916
Brief Title
Functional Electrical Stimulation (FES) Assisted Walking: Enhancement of Walking Function After Stroke
Official Title
Functional Electrical Stimulation (FES)-Assisted Walking: Enhancement of Voluntary Walking Function Among Persons With Severe Hemiplegia Post-Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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.
Arm Title
2
Arm Type
Other
Arm Description
The intervention group will receive 'true' FES
Intervention Type
Device
Intervention Name(s)
Compex Motion Stimulator
Intervention Description
'True' Functional Electrical Stimulation Assisted Walking
Intervention Type
Device
Intervention Name(s)
Compex Motion Stimulator
Intervention Description
'False' FES
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry
Time Frame
Baseline, 2-month and 6-month
Title
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naaz Kapadia, MSc
Phone
416-597-3422
Ext
6310
Email
kapadia.naaz@torontorehab.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milos R Popovic, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute: Lyndhurst Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naaz Kapadia, MSc
Phone
416-597-3422
Ext
6310
Email
kapadia.naaz@torontorehab.on.ca
First Name & Middle Initial & Last Name & Degree
Milos R Popovic, PhD
Email
milos.popovic@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Molly Verrier, M.H.Sc., Dip(P&OT)
First Name & Middle Initial & Last Name & Degree
Denyse Richardson, MD
First Name & Middle Initial & Last Name & Degree
Lora Giangregorio, PhD
First Name & Middle Initial & Last Name & Degree
Lehana Thabane, PhD
First Name & Middle Initial & Last Name & Degree
Nancy Salbach, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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