StrokePhase 4NCT00552916
Functional Electrical Stimulation (FES) Assisted Walking: Enhancement of Walking Function After Stroke
A Phase 4 study testing Compex Motion Stimulator in people with Stroke, run by Toronto Rehabilitation Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Compex Motion Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Rehabilitation Institute: Lyndhurst Centre
Toronto, Ontario, M4G 3V9
Naaz Kapadia, MSc, 416-597-3422 ext. 6310, kapadia.naaz@torontorehab.on.ca
Milos R Popovic, PhD, milos.popovic@utoronto.ca
About this study
Official title: Functional Electrical Stimulation (FES)-Assisted Walking: Enhancement of Voluntary Walking Function Among Persons With Severe Hemiplegia Post-Stroke
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.
Read the 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
- Stroke
- Being tested
- Compex Motion Stimulator
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compex Motion StimulatorDevice
'True' Functional Electrical Stimulation Assisted Walking
Compex Motion StimulatorDevice
'False' FES
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 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. Receives: Device: Compex Motion Stimulator |
| 2 | Other | The intervention group will receive 'true' FES Receives: Device: Compex Motion Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Test performed weekly during 8-week period as well as at 2 month and 6 month time point.
Secondary outcomes (3)
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.
Measured: Baseline, 2 month and 6 month period.
Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry
Measured: 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.
Measured: Baseline, 2-month and 6-month time points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Investigators
- Milos R Popovic, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552916
- Sponsor's protocol ID
- SRA 5973
- Status last verified
- Aug 2008
- First submitted
- 1 Nov 2007
- Last updated
- 20 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation (FES)-Assisted Walking: Enhancement of Voluntary Walking Function Among Persons With Severe Hemiplegia Post-Stroke
- ClinicalTrials.gov ID
- NCT00552916
- Acronym / sponsor ID
- SRA 5973
- Conditions
- Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Oct 2007
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Compex Motion StimulatorParticipants 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. |
| 2 | Other | Device: Compex Motion StimulatorThe intervention group will receive 'true' FES |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compex Motion Stimulator'True' Functional Electrical Stimulation Assisted Walking | Device | 2 |
| Compex Motion Stimulator'False' FES | Device | 1 |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milos R Popovic, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compex Motion Stimulator in people with Stroke, run by Toronto Rehabilitation Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naaz Kapadia, MSc (416-597-3422 ext. 6310, kapadia.naaz@torontorehab.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2008.