Self-regulated Constraint-induced Movement Therapy in Subacute Stroke Patients

University of Western Sydney

Status: Completed

Conditions: Stroke

Treatments: Other: Conventional occupational therapy; Other: Constraint-induced movement therapy; Other: Self-regulated constraint-induced movement therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02480140

SR-CIMT

Details and patient eligibility

About

Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT). This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with subacute stroke. It was hypothesized that participants receiving the combined treatment (SR and CIMT) would have a better functional regain.

Full description

Background - Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT).

Objective - This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with sub-acute stroke.

Methods - Seventy-six patients were randomly assigned to the self-regulated constraint-induced movement therapy (SR-CIMT; n=25), constraint-induced movement therapy (CIMT; n=27) or conventional functional rehabilitation (control; n=24) groups, and completed the trial.

The SR-CIMT intervention was two-week therapist-guided training using the SR strategy to reflect on the relearning of functional tasks with CIMT. Outcome measurements were for upper limb function (Action Research Arm Test, ARAT, Fugl-Meyer Assessment, FMA), daily task performance (Lawton Instrumental Activities of Daily Living Scale, Lawton IADL) and self-perceived functional ability (Motor Activity Log, MAL) at pre and post intervention intervals, and at one month follow up.

Enrollment: 76 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• sustained an ischemic type stroke with lesion in the primary or motor cortical areas resulting in hemiplegia,
• had stroke onset of less than 3 months,
• were aged above 60, and
• had 10 degree active extension in metacarpophalangeal joint and interphalangeal joint, 20 degree active extension of wrist joint

Exclusion criteria

• had excessive spasticity in the affected limb, as defined by a score of 2 or more on the Modified Ashworth Scale,
• had excessive pain in the affected limb, as defined by a score 4 or more using a Visual Analog Scale,
• had a score below 19 on the Mini-Mental Status Examination (MMSE), and
• had diagnosed of depression according to Diagnostic and Statistical Manual-IV (DSM-IV) criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 3 patient groups

Self-regulated constraint-induced movement therapy

Experimental group

Description:

Self-regulated constraint-induced movement therapy (SR-CIMT) - participants' non-hemiplegic arm was restrained in a mitt for 4 hours every day, 2 weeks, 5 days a week (therapy days) (CIMT) (the same CIMT protocol as in the CIMT group described under 'comparator/control treatment'); participants were taught using the self-regulation (SR) strategy to relearn the tasks; SR strategy involved participants self reflecting on their abilities and deficits in performing the tasks, identifying problems and solutions in achieving the most independence in the tasks, and then actually carrying out the tasks.

Treatment:

Other: Self-regulated constraint-induced movement therapy

Constraint-induced movement therapy

Active Comparator group

Description:

In the constraint-induced movement therapy group (CIMT), participants' non-hemiplegic arm was restrained in a mitt for 4 hours every day, 2 weeks, 5 days a week (therapy days); therapist provided demonstration on the adapted task performance with one arm (the side of participants' hemiplegic arm), and participants to practice the tasks with the unrestrained hemiplegic arm under supervision.

Treatment:

Other: Constraint-induced movement therapy

Conventional occupational therapy

Active Comparator group

Description:

It involved therapist to demonstrate the adapted task performance followed by patient's practice under supervision.

Treatment:

Other: Conventional occupational therapy