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

NCT ID: NCT02480140

Last Updated: 2015-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-10-31

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.

Conditions

Stroke

Study Design

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

Study Groups

Self-regulated constraint-induced movement therapy

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.

Group Type: EXPERIMENTAL

Self-regulated constraint-induced movement therapy

Intervention Type: OTHER

There were 10 tasks to practice in total, they included fold laundry, put clothes on hanger, brush teeth, dress upper garment, dress lower garment in week one; and use telephone, prepare a cup of tea, sweep floor, wash towel, wash dishes in week two. In the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using SR strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward.

Constraint-induced movement therapy

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.

Group Type: ACTIVE_COMPARATOR

Constraint-induced movement therapy

Intervention Type: OTHER

They practised the same 10 tasks as in the SR-CIMT and control groups. The same as the experimental intervention group (SR-CIMT), in the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using the strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward.

Conventional occupational therapy

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

Group Type: ACTIVE_COMPARATOR

Conventional occupational therapy

Intervention Type: OTHER

They practised the same 10 tasks as in the SR-CIMT group described above. They received training for 2 weeks, 5 days a week (therapy days), the same as in the SR-CIMT and CIMT groups.

Interventions

Self-regulated constraint-induced movement therapy

There were 10 tasks to practice in total, they included fold laundry, put clothes on hanger, brush teeth, dress upper garment, dress lower garment in week one; and use telephone, prepare a cup of tea, sweep floor, wash towel, wash dishes in week two. In the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using SR strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward.

Intervention Type: OTHER

Constraint-induced movement therapy

They practised the same 10 tasks as in the SR-CIMT and control groups. The same as the experimental intervention group (SR-CIMT), in the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using the strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward.

Intervention Type: OTHER

Conventional occupational therapy

They practised the same 10 tasks as in the SR-CIMT group described above. They received training for 2 weeks, 5 days a week (therapy days), the same as in the SR-CIMT and CIMT groups.

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: collaborator

University of Western Sydney

OTHER

Sponsor Role: lead

Responsible Party

Karen Liu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen P.Y. Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Western Sydney

Locations

Shatin Hospital

Hong Kong, , Hong Kong

Pok Oi Hospital

Yuen Long, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Other Identifiers

SR-CIMT

Identifier Type: -

Identifier Source: org_study_id