StrokeNCT00359255
The Effect of Additional Arm Therapy on Arm Function After Stroke
A study testing Education manual and An inpatient homework based exercise program for the upper limb post stroke in people with Stroke, run by University of British Columbia at 4 sites in Canada.
Trial summary
This study would focus on a new method of adding extra arm exercise to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected arm and hand that would be given to the client as homework and done in the client's hospital room. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Education manual and An inpatient homework based exercise program for the upper limb post stroke
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesCanada
- Study dates
- Jul 2006to Dec 2008
- 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
- 19 years of age or older
- arm recovery as a rehabilitation goal
- have palpatable movement of wrist extension
- able to follow 3 step verabal commands
Who cannot join
- unstable cardiovascular status (congestive heart failure, uncontrolled hypertension, uncontrolled atrial fibrillation, or left ventricular failure),
- significant musculo-skeletal problems (e.g., rheumatoid arthritis) or neurological conditions (e.g., Parkinson's disease) due to conditions other than stroke,
- receptive aphasia
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Kelowna General Hospital
Kelowna, 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: The Effect of a Supplementary Exercise Program for Upper Extremity Function in Stroke Rehabilitation
This study would focus on a new method of adding extra arm exercise to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected arm and hand that would be given to the client as homework and done in the client's hospital room. The program would be designed and monitored by a therapist that works in the hospital.
We believe that this program will: 1) increase arm and hand recovery over usual care received in the hospital, 2) help people make the move from therapist run exercise to self management of exercise, and 3) promote family involvement in therapy.
Read the detailed description
In total 250 participants admitted for stroke rehabilitation at 4 BC sites will be randomly assigned to either the experimental or the control group. The extra arm and hand exercise program (experimental group) will receive usual therapy plus 60 minutes per day of additional arm exercises. This program will last for 4 weeks while the participant is in the hospital. The arm and hand program will include muscle strengthening and stretching, repetitive reaching, folding, stacking, pushing and pulling tasks, picking up objects, and activities that use speed and accuracy. The family will be encouraged to participate in the program with the participant. The control group will receive usual therapy only.
- Conditions
- Stroke
- Being tested
- Education manual, An inpatient homework based exercise program for the upper limb post stroke
- Keywords
- Exercise, rehabilitation, upper limb, inpatient, RCT, activities of daily living
- 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.
Education manualBehavioural
The control arm was given education on stroke, the affected arm post strooke, bone health, and healthy living. This information was given in a booklet format and administered once weekly by the site coordinator.
An inpatient homework based exercise program for the upper limb post strokeBehavioural
The experimental arm was given arm exercises graded based on motor impairment and administered by the site coordinator. The exercises were given in a booklet with written and photographic instructions. These exercises were monitored on a twice-weekly basis.
The intervention was to be completed once daily for 45 minutes, 5 days per week, and supervised by the site coordinator. Exercises consisted of range of motion, strengthening, and use of the arm in daily activites such as buttoning, pouring and throwing.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Behavioral: Education manual |
| 2 | Experimental | Not described Receives: Behavioral: An inpatient homework based exercise program for the upper limb post stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the ability to use the paretic arm in activities of daily living. This outcome will be measured pre and post program.
Secondary outcomes (1)
Secondary outcomes include amount of use and quality of movement of the paretic arm, motor recovery, strength, tone, and health related quality of life. Each of these measures will be evaluated pre and post program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 120 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, Ph.D, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359255
- Sponsor's protocol ID
- C05-0680
- Other IDs
- VO6-0117
- Status last verified
- May 2017
- First submitted
- 28 Jul 2006
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harris JE, Eng JJ, Miller WC, Dawson AS. A self-administered Graded Repetitive Arm Supplementary Program (GRASP) improves arm function during inpatient stroke rehabilitation: a multi-site randomized controlled trial. Stroke. 2009 Jun;40(6):2123-8. doi: 10.1161/STROKEAHA.108.544585. Epub 2009 Apr 9.
PubMed 19359633
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
- The Effect of a Supplementary Exercise Program for Upper Extremity Function in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT00359255
- Acronym / sponsor ID
- C05-0680
- Conditions
- Stroke
- Keywords
- Exercise, rehabilitation, upper limb, inpatient, RCT, activities of daily living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Jul 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Aug 2006 (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 arm exercise to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected arm and hand that would be given to the client as homework and done in the client's hospital room. The program would be designed and monitored by a therapist that works in the hospital.
We believe that this program will: 1) increase arm and hand recovery over usual care received in the hospital, 2) help people make the move from therapist run exercise to self management of exercise, and 3) promote family involvement in therapy.
Detailed description
In total 250 participants admitted for stroke rehabilitation at 4 BC sites will be randomly assigned to either the experimental or the control group. The extra arm and hand exercise program (experimental group) will receive usual therapy plus 60 minutes per day of additional arm exercises. This program will last for 4 weeks while the participant is in the hospital. The arm and hand program will include muscle strengthening and stretching, repetitive reaching, folding, stacking, pushing and pulling tasks, picking up objects, and activities that use speed and accuracy. The family will be encouraged to participate in the program with the participant. The control group will receive usual therapy only.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Education manual |
| 2 | Experimental | Behavioral: An inpatient homework based exercise program for the upper limb post stroke |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19 years of age or older
- arm recovery as a rehabilitation goal
- have palpatable movement of wrist extension
- able to follow 3 step verabal commands
Key exclusion criteria (3 listed)
- unstable cardiovascular status (congestive heart failure, uncontrolled hypertension, uncontrolled atrial fibrillation, or left ventricular failure),
- significant musculo-skeletal problems (e.g., rheumatoid arthritis) or neurological conditions (e.g., Parkinson's disease) due to conditions other than stroke,
- receptive aphasia
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 |
|---|---|---|
| Education manualThe control arm was given education on stroke, the affected arm post strooke, bone health, and healthy living. This information was given in a booklet format and administered once weekly by the site coordinator. | Behavioural | 1 |
| An inpatient homework based exercise program for the upper limb post strokeThe experimental arm was given arm exercises graded based on motor impairment and administered by the site coordinator. The exercises were given in a booklet with written and photographic instructions. These exercises were monitored on a twice-weekly basis. The intervention was to be completed once daily for 45 minutes, 5 days per week, and supervised by the site coordinator. Exercises consisted of range of motion, strengthening, and use of the arm in daily activites such as buttoning, pouring and throwing. | Behavioural | 2 |
Primary outcome
The primary outcome is the ability to use the paretic arm in activities of daily living. This outcome will be measured pre and post program.
1 secondary outcome
Secondary outcomes include amount of use and quality of movement of the paretic arm, motor recovery, strength, tone, and health related quality of life. Each of these measures will be evaluated pre and post program.
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.
- Results publication: PubMed 19359633Harris JE, Eng JJ, Miller WC, Dawson AS. A self-administered Graded Repetitive Arm Supplementary Program (GRASP) improves arm function during inpatient stroke rehabilitation: a multi-site randomized controlled trial. Stroke. 2009 Jun;40(6):2123-8. doi: 10.1161/STROKEAHA.108.544585. Epub 2009 Apr 9.
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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, Ph.D principal investigator
The University of British Columbia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education manual and An inpatient homework based exercise program for the upper limb post stroke in people with Stroke, run by University of British Columbia at 4 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 4 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 the ability to use the paretic arm in activities of daily living. This outcome will be measured pre and post program.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00359255, which also lists 1 linked publication.
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.