Clinical trial NCT02480140: Self-regulated Constraint-induced Movement Therapy in Subacute Stroke Patients
Official title: Self-regulated Constraint-induced Movement Therapy in Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Self-regulation
Constraint-induced movement therapy
Stroke
Functional recovery
Randomized controlled trial
Lead sponsor: University of Western Sydney
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2015-06-24
Enrollment: 76
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Lawton Instrumental Activities of Daily Living Scale after the intervention
timeFrame: Baseline and after the intervention (2 weeks)
measure: Change from baseline in Lawton Instrumental Activities of Daily Living Scale at one month after the intervention completed
timeFrame: Baseline and one month after the intervention completed (1 month and 2 weeks)
measure: Change from baseline in Action Research Arm Test after the intervention
timeFrame: Baseline and after the intervention (2 weeks)
measure: Change from baseline in Action Research Arm Test at one month after the intervention completed
timeFrame: Baseline and one month after the intervention completed (1 month and 2 weeks)
measure: Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection after the intervention
timeFrame: Baseline and after the intervention (2 weeks)
measure: Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection at one month after the intervention completed
timeFrame: Baseline and one month after the intervention completed (1 month and 2 weeks)
Secondary outcomes:
measure: Change from baseline in Motor Activity Log-28 after the intervention
timeFrame: Baseline and after the intervention (2 weeks)
measure: Change from baseline in Motor Activity Log-28 at one month after the intervention completed
timeFrame: Baseline and one month after the intervention completed (1 month and 2 weeks)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Shatin Hospital
city: Yuen Long
country: Hong Kong
facility: Pok Oi Hospital
Study officials:
affiliation: University of Western Sydney
name: Karen P.Y. Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam, K., Liu, K., Leung, T., Sum, C., Yue, A. & Mok, V. (2013, 24-26 July). The effectiveness of self-regulated constraint-induced movement therapy for functional regain for people with sub-acute stroke: A randomized controlled trial. Australian Occupational Therapy Journal, 110.
citation: Leung, T., Liu, K.P.Y., Sum, C., Mok, V. & Lum, C. (2010). Self-regulation constraint-induced movement therapy programme for people with subacute stroke. Hong Kong Hospital Authority Rehabilitation Symposium.
citation: Leung, T., Liu, K.P.Y., Sum, C., Mok, V. & Lum, C. (2010). Self-regulation constraint-induced movement therapy programme for people with subacute stroke. Hong Kong Journal of Occupational Therapy,19, A8.