Atlantic Canada Modified Constraint Induced Movement Therapy Trial

Completed

Phase N/A Results N/A

Trial Description

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

Interventions

  • Modified constraint induced movement therapy (mCIMT) Behavioral
    Intervention Desc: 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 1: Kind: Experimental
    Label: modified CIMT (mCIMT)
  • Usual and Customary Care Other
    Other Names: Standard care
    Intervention Desc: 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 1: Kind: Experimental
    Label: Usual Care

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 No
Secondary 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 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 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 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

Sponsors