- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01283620
Atlantic Canada Modified Constraint Induced Movement Therapy Trial
May 6, 2015 updated by: Shaun Boe, Nova Scotia Health Authority
The purpose of this study is to examine the effectiveness and feasibility of a modified constraint induced movement therapy (mCIMT) intervention on upper limb function in two groups of patients acutely post-stroke; 1) an experimental group that will participate in a 10 week mCIMT intervention designed to improve upper limb function, in addition to usual care, and 2) a control group that will participate in a program of usual care consisting of a rehabilitation intervention for the affected upper limb that is dose-matched to the experimental group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
- Capital Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- first symptomatic stroke (either ischemic or hemorrhagic) resulting in upper limb hemiparesis
- the ability to perform a two-step command
- age ≥ 18 years
- residence within a 75 km radius of the Queen Elizabeth II Health Sciences Centre
- with regard to the affected upper limb, subjects will meet standard criteria for modified constraint induced movement therapy (mCIMT) including at least 10 degrees of active wrist extension, at least 10 degrees of thumb abduction/extension, and at least 10 degrees of extension in two additional digits, repeated three times in one minute
Exclusion Criteria:
- have excessive pain in the affected upper limb (defined as > 4 on a 10 centimeter visual analog scale)
- presence of dementia or aphasia as defined by a score of < 26 on the Montreal Cognitive Assessment
- have a diagnosis of pre-stroke dementia
- have a terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness
- excessive tone in the upper limb (> 3 on the modified Ashworth Scale)
- Motor Activity Log score > 2.5 (amount of use sub-scale)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Usual Care
|
Patients in this arm will receive usual care dose-matched to the experimental care group.
Usual care will consist of occupational and physiotherapy intervention focused on affected upper limb range of motion (i.e., active range of motion incorporated into functional tasks such as reaching), strengthening (i.e., upper limb resisted exercise), manual dexterity exercises (i.e., grasp and release, stacking cones), and general aerobic conditioning (i.e., recumbent stepper, treadmill).
|
Experimental: modified CIMT (mCIMT)
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The intervention group will receive usual care plus mCIMT.
mCIMT consists of two components delivered in parallel: three 30 min therapy sessions/week focusing on progressively more difficult tasks performed with the arm/hand, and five hours/weekday of restraint of the unaffected upper limb.
Each 30 min therapy session consists of using the affected upper limb in practicing 4-5 functionally relevant tasks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in arm and hand function at 10 weeks, 6 and 12 months relative to baseline performance
Time Frame: At 0 weeks, 10 weeks, 6 months and 12 months
|
Change in arm and hand function will be performed using the Action Research Arm Test, which measures function of the arm and hand using 19 tasks in four different categories (grip, grasp, pinch and gross motor).
Performance on each task is scored from 0 (cannot perform any part of the test) to 3 (performs the test normally) for a possible score of 0-57.
Improved arm and hand function will be determined by detecting a change in score by comparing performance at each of the post-treatment assessment points (10 weeks, 6 and 12 months) relative to baseline performance.
|
At 0 weeks, 10 weeks, 6 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the quality and amount of arm and hand use at 10 weeks, 6 and 12 months relative to baseline.
Time Frame: At 0 weeks, 10 weeks, 6 months and 12 months
|
Improved arm and hand function based on the quality and amount of use will be determined by detecting a change in score by comparing performance at each post-treatment assessment point (10 weeks, 6 and 12 months) relative to baseline performance using the Motor Activity Log.
The Motor Activity Log is a semi-structured interview which measures how much and how well a person is using the affected arm and hand compared to their pre-stroke condition.
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At 0 weeks, 10 weeks, 6 months and 12 months
|
Greater satisfaction with treatment compared to the usual care group based on higher scores on the Satisfaction with Stroke Care Questionnaire (SASC-19) in the experimental treatment group
Time Frame: At 10 weeks
|
Overall satisfaction with treatment will be measured in each group using the Satisfaction with Stroke Care Questionnaire (SASC-19), which includes 19 questions relating to a patients satisfaction with their care and treatment.
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At 10 weeks
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Improved return to normal activities in the experimental treatment group as measured by higher scores on the Re-integration to Normal Living Index (RNLI) 6 months post-treatment
Time Frame: At 6 months
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At 6 months
|
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Change in the amount of use of the arm and hand in everyday life at 10 weeks, 6 and 12 months relative to baseline as detected with accelerometers
Time Frame: At 0 weeks, 10 weeks, 6 months and 12 months
|
Accelerometers will be worn on both wrists to quantitatively assess the amount of movement that occurs over a three day period at each of the time points.
Improved use of the arm and hand will be determined based on a change in activity at each of the post-treatment assessment points (10 weeks, 6 and 12 months) relative to activity measured at baseline.
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At 0 weeks, 10 weeks, 6 months and 12 months
|
Improved return to normal activities in the experimental treatment group as measured by higher scores on the Re-integration to Normal Living Index (RNLI) 12 months post-treatment
Time Frame: At 12 months
|
At 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shaun G Boe, MPT, PhD, Dalhousie University/Capital Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 21, 2011
First Submitted That Met QC Criteria
January 25, 2011
First Posted (Estimate)
January 26, 2011
Study Record Updates
Last Update Posted (Estimate)
May 7, 2015
Last Update Submitted That Met QC Criteria
May 6, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDHA-RS/2011-277
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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