Back to resultsAtlantic Canada Modified Constraint Induced Movement Therapy Trial
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
modified constraint induced movement therapy (mCIMT)
Usual and Customary Care
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, extremity, upper
Eligibility Criteria
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)
Sites / Locations
- Capital Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Usual Care
modified CIMT (mCIMT)
Arm Description
Outcomes
Primary Outcome Measures
Change in arm and hand function at 10 weeks, 6 and 12 months relative to baseline performance
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.
Secondary Outcome Measures
Change in the quality and amount of arm and hand use at 10 weeks, 6 and 12 months relative to baseline.
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.
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
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.
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
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
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.
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
Full Information
NCT ID
NCT01283620
First Posted
January 21, 2011
Last Updated
May 6, 2015
Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University, Sunnybrook Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01283620
Brief Title
Atlantic Canada Modified Constraint Induced Movement Therapy Trial
Official Title
Atlantic Canada Modified Constraint Induced Movement Therapy Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University, Sunnybrook Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, extremity, upper
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Other
Arm Title
modified CIMT (mCIMT)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
modified constraint induced movement therapy (mCIMT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual and Customary Care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in arm and hand function at 10 weeks, 6 and 12 months relative to baseline performance
Description
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.
Time Frame
At 0 weeks, 10 weeks, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in the quality and amount of arm and hand use at 10 weeks, 6 and 12 months relative to baseline.
Description
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.
Time Frame
At 0 weeks, 10 weeks, 6 months and 12 months
Title
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
Description
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.
Time Frame
At 10 weeks
Title
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
Title
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
Description
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.
Time Frame
At 0 weeks, 10 weeks, 6 months and 12 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaun G Boe, MPT, PhD
Organizational Affiliation
Dalhousie University/Capital Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Health
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
12. IPD Sharing Statement
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Atlantic Canada Modified Constraint Induced Movement Therapy Trial
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