Atlantic Canada Modified Constraint Induced Movement Therapy Trial

Atlantic Canada Modified Constraint Induced Movement Therapy Trial

Sponsors

Lead sponsor: Nova Scotia Health Authority

Collaborator: Dalhousie University
Sunnybrook Research Institute

Source Nova Scotia Health Authority
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.

Overall Status Completed
Start Date December 2011
Completion Date December 2014
Primary Completion Date December 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in arm and hand function at 10 weeks, 6 and 12 months relative to baseline performance At 0 weeks, 10 weeks, 6 months and 12 months
Secondary Outcome
Measure Time Frame
Change in the quality and amount of arm and hand use at 10 weeks, 6 and 12 months relative to baseline. 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 At 10 weeks
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 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 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 At 12 months
Enrollment 14
Condition
Intervention

Intervention type: Behavioral

Intervention name: modified constraint induced movement therapy (mCIMT)

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.

Arm group label: modified CIMT (mCIMT)

Intervention type: Other

Intervention name: Usual and Customary Care

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).

Arm group label: Usual Care

Eligibility

Criteria:

Inclusion Criteria:

1. first symptomatic stroke (either ischemic or hemorrhagic) resulting in upper limb hemiparesis

2. the ability to perform a two-step command

3. age ≥ 18 years

4. residence within a 75 km radius of the Queen Elizabeth II Health Sciences Centre

5. 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:

1. have excessive pain in the affected upper limb (defined as > 4 on a 10 centimeter visual analog scale)

2. presence of dementia or aphasia as defined by a score of < 26 on the Montreal Cognitive Assessment

3. have a diagnosis of pre-stroke dementia

4. have a terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness

5. excessive tone in the upper limb (> 3 on the modified Ashworth Scale)

6. Motor Activity Log score > 2.5 (amount of use sub-scale)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Shaun G Boe, MPT, PhD Principal Investigator Dalhousie University/Capital Health
Location
facility
Capital Health
Location Countries

Canada

Verification Date

May 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Nova Scotia Health Authority

Investigator full name: Shaun Boe

Investigator title: Affiliate Scientist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Usual Care

Arm group type: Other

Arm group label: modified CIMT (mCIMT)

Arm group type: Experimental

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov