Clinical trial NCT01283620: Atlantic Canada Modified Constraint Induced Movement Therapy Trial
Official title: Atlantic Canada Modified Constraint Induced Movement Therapy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
extremity, upper
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
name: Sunnybrook Research Institute
First posted: 2011-01-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in arm and hand function at 10 weeks, 6 and 12 months relative to baseline performance
timeFrame: At 0 weeks, 10 weeks, 6 months and 12 months
Secondary outcomes:
measure: Change in the quality and amount of arm and hand use at 10 weeks, 6 and 12 months relative to baseline.
timeFrame: At 0 weeks, 10 weeks, 6 months and 12 months
measure: 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
timeFrame: At 10 weeks
measure: 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
timeFrame: At 6 months
measure: 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
timeFrame: At 0 weeks, 10 weeks, 6 months and 12 months
measure: 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
timeFrame: At 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital Health
state: Nova Scotia
Study officials:
affiliation: Dalhousie University/Capital Health
name: Shaun G Boe, MPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: