Atlantic Canada Modified Constraint Induced Movement Therapy Trial

Stroke Clinical Trial

Official title:

Atlantic Canada Modified Constraint Induced Movement Therapy Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283620
• Other study ID #: CDHA-RS/2011-277
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: May 6, 2015
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

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).

Locations

Country	Name	City	State
Canada	Capital Health	Halifax	Nova Scotia

Sponsors (3)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Dalhousie University, Sunnybrook Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 0 weeks, 10 weeks, 6 months and 12 months	No
Secondary	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.	At 0 weeks, 10 weeks, 6 months and 12 months	No
Secondary	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.	At 10 weeks	No
Secondary	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	No
Secondary	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.	At 0 weeks, 10 weeks, 6 months and 12 months	No
Secondary	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	No