Atlantic Canada Modified Constraint Induced Movement Therapy Trial

NCT ID: NCT01283620

Last Updated: 2015-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Group Type: OTHER

Usual and Customary Care

Intervention Type: OTHER

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).

modified CIMT (mCIMT)

Group Type: EXPERIMENTAL

modified constraint induced movement therapy (mCIMT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalhousie University

OTHER

Sponsor Role: collaborator

Sunnybrook Research Institute

OTHER

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Shaun Boe

Affiliate Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaun G Boe, MPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University/Capital Health

Locations

Capital Health

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

CDHA-RS/2011-277

Identifier Type: -

Identifier Source: org_study_id