Cerebrovascular Accident (Stroke)NCT00908479
The Effect of an Inpatient Home-work Exercise Program on Leg Function After Stroke
A study testing Leg Exercise Program and Leg Management group in people with Cerebrovascular Accident (Stroke), run by University of British Columbia at 5 sites in Canada.
Trial summary
This study would focus on a new method of adding extra leg homework exercises to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected leg that would be given to the client as homework and done in the client's hospital room or ward. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cerebrovascular Accident (Stroke)
- What is being tested?
- Leg Exercise Program and Leg Management group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 5 sitesCanada
- Study dates
- Sep 2009to Apr 2013
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been admitted to a hospital unit for stroke treatment
- 19 years or older
- Are experiencing difficulty using legs
- Able to understand and follow instructions
Who cannot join
- Have uncontrolled hypertension or unstable cardio-vascular condition
- Injuries to muscles, bones, or joints of the leg
- Unable to verbally speak or understand the investigators when asked questions
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Nanaimo Regional General Hospital
Nanaimo, British Columbia
Eagle Ridge Hospital
Port Moody, British Columbia
GF Strong Rehab Center
Vancouver, British Columbia
Holy Family Hospital
Vancouver, British Columbia
Victoria General Hospital
Victoria, British Columbia
About this study
Official title: Exercise Programs for Stroke: Effect of an Inpatient Supplementary Practice Program on Lower Extremity Function
This study would focus on a new method of adding extra leg homework exercises to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected leg that would be given to the client as homework and done in the client's hospital room or ward. The program would be designed and monitored by a therapist that works in the hospital.
Read the detailed description
In total 120 participants admitted for stroke rehabilitation in the province British Columbia, Canada will be randomly assigned to either the Leg Exercise group or Leg Management group. The extra leg exercise group (experimental group) will receive usual therapy plus 60 minutes per day of self-directed leg exercises. This program will last for 4 weeks while the participant is in the hospital. The Leg Exercise program will include exercises of range of motion, leg strengthening, weight-bearing, and walking. The family will be encouraged to participate in the program with the participant. The control group (Leg Management group) will receive usual therapy and stroke education.
- Conditions
- Cerebrovascular Accident (Stroke)
- Being tested
- Leg Exercise Program, Leg Management group
- Keywords
- Exercise, Rehabilitation, leg function, in patient, RCT
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg Exercise ProgramBehavioural
Also called Inpatient supplementary practice program on lower extremity function
Participants will engage in an extra 45-60 minutes per day of self-managed lower extremity homework exercises focused on improving strength, balance and walking ability.
Leg Management groupBehavioural
Therapist provides educational information about leg pain, recovery, bone density, and fall risk.
| Study group | Role | What they receive |
|---|---|---|
| LE | Experimental | Leg Exercise group Receives: Behavioral: Leg Exercise Program |
| LM | Experimental | Leg Management (Control group) Receives: Behavioral: Leg Management group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is gait speed
Measured: 4 weeks post-intervention
Secondary outcomes (1)
The secondary outcomes will assess the effect of the experimental intervention on balance and physical activity
Measured: 4 weeks post-baseline, then 6 and 12 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular Accident (Stroke)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Janice Eng, University of British Columbia
- Investigators
- Janice Eng, Principal investigator, University of British ColumbiaWilliam Miller, Study director, University of British ColumbiaAndrew Dawson, Study director, University of British ColumbiaPenny Brasher, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908479
- Sponsor's protocol ID
- H09-00665
- Status last verified
- May 2017
- First submitted
- 26 May 2009
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Programs for Stroke: Effect of an Inpatient Supplementary Practice Program on Lower Extremity Function
- ClinicalTrials.gov ID
- NCT00908479
- Acronym / sponsor ID
- H09-00665
- Conditions
- Cerebrovascular Accident (Stroke)
- Keywords
- Exercise, Rehabilitation, leg function, in patient, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Sep 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 27 May 2009 (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.
This study would focus on a new method of adding extra leg homework exercises to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected leg that would be given to the client as homework and done in the client's hospital room or ward. The program would be designed and monitored by a therapist that works in the hospital.
Detailed description
In total 120 participants admitted for stroke rehabilitation in the province British Columbia, Canada will be randomly assigned to either the Leg Exercise group or Leg Management group. The extra leg exercise group (experimental group) will receive usual therapy plus 60 minutes per day of self-directed leg exercises. This program will last for 4 weeks while the participant is in the hospital. The Leg Exercise program will include exercises of range of motion, leg strengthening, weight-bearing, and walking. The family will be encouraged to participate in the program with the participant. The control group (Leg Management group) will receive usual therapy and stroke education.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LE | Experimental | Behavioral: Leg Exercise ProgramLeg Exercise group |
| LM | Experimental | Behavioral: Leg Management groupLeg Management (Control group) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have been admitted to a hospital unit for stroke treatment
- 19 years or older
- Are experiencing difficulty using legs
- Able to understand and follow instructions
Key exclusion criteria (3 listed)
- Have uncontrolled hypertension or unstable cardio-vascular condition
- Injuries to muscles, bones, or joints of the leg
- Unable to verbally speak or understand the investigators when asked questions
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 |
|---|---|---|
| Leg Exercise ProgramAlso: Inpatient supplementary practice program on lower extremity functionParticipants will engage in an extra 45-60 minutes per day of self-managed lower extremity homework exercises focused on improving strength, balance and walking ability. | Behavioural | LE |
| Leg Management groupTherapist provides educational information about leg pain, recovery, bone density, and fall risk. | Behavioural | LM |
Primary outcome
The primary outcome is gait speed
Time frame: 4 weeks post-intervention
1 secondary outcome
The secondary outcomes will assess the effect of the experimental intervention on balance and physical activity
Time frame: 4 weeks post-baseline, then 6 and 12 months post-stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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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.
Janice Eng principal investigator
University of British Columbia
William Miller study director
University of British Columbia
Andrew Dawson study director
University of British Columbia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg Exercise Program and Leg Management group in people with Cerebrovascular Accident (Stroke), run by University of British Columbia at 5 sites 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 3 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: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is gait speed (time frame: 4 weeks post-intervention). 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 10 May 2017.