Atlantic Canada Modified Constraint Induced Movement Therapy Trial
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|ClinicalTrials.gov Identifier: NCT01283620|
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : May 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: modified constraint induced movement therapy (mCIMT) Other: Usual and Customary Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Atlantic Canada Modified Constraint Induced Movement Therapy Trial|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Other: Usual and Customary 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)||
Behavioral: modified constraint induced movement therapy (mCIMT)
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.
- 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.
- 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.
- 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.
- 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 ]
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283620
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Principal Investigator:||Shaun G Boe, MPT, PhD||Dalhousie University/Capital Health|