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

NCT02480140 | Completed

• 1 other identifier: SR-CIMT
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Self-regulation; Constraint-induced movement therapy; Stroke; Functional recovery; Randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• Change from baseline in Lawton Instrumental Activities of Daily Living Scale after the intervention

  Performance assessment on 8 daily tasks

  Baseline and after the intervention (2 weeks)

• Change from baseline in Lawton Instrumental Activities of Daily Living Scale at one month after the intervention completed

  Performance assessment on 8 daily tasks

  Baseline and one month after the intervention completed (1 month and 2 weeks)

• Change from baseline in Action Research Arm Test after the intervention

  Performance assessment on arm function

  Baseline and after the intervention (2 weeks)

• Change from baseline in Action Research Arm Test at one month after the intervention completed

  Performance assessment on arm function

  Baseline and one month after the intervention completed (1 month and 2 weeks)

• Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection after the intervention

  Performance assessment on arm function

  Baseline and after the intervention (2 weeks)

• Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection at one month after the intervention completed

  Performance assessment on arm function

  Baseline and one month after the intervention completed (1 month and 2 weeks)

Secondary Outcomes (2)

• Change from baseline in Motor Activity Log-28 after the intervention

  Baseline and after the intervention (2 weeks)

• Change from baseline in Motor Activity Log-28 at one month after the intervention completed

  Baseline and one month after the intervention completed (1 month and 2 weeks)

Study Arms (3)

Self-regulated constraint-induced movement therapy

EXPERIMENTAL

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.

Other: Self-regulated constraint-induced movement therapy

Constraint-induced movement therapy

ACTIVE COMPARATOR

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.

Other: Constraint-induced movement therapy

Conventional occupational therapy

ACTIVE COMPARATOR

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

Other: Conventional occupational therapy

Interventions

Self-regulated constraint-induced movement therapy 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.

Self-regulated constraint-induced movement therapy

Constraint-induced movement therapy 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.

Constraint-induced movement therapy

Conventional occupational therapy 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.

Conventional occupational therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Western Sydney: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (2)

Shatin Hospital

Hong Kong, Hong Kong

Location

Pok Oi Hospital

Yuen Long, Hong Kong

Location

Related Publications (3)

• 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.

  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.

  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.

  BACKGROUND

MeSH Terms

Conditions

Stroke; Self-Control

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Karen P.Y. Liu, PhD

  University of Western Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 24, 2015
• Study Start: September 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 29, 2015

Record last verified: 2015-06

Locations

HK (2)