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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Self-regulated constraint-induced movement therapy
Constraint-induced movement therapy
Conventional occupational therapy
Sponsored by
University of Western Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Self-regulation, Constraint-induced movement therapy, Stroke, Functional recovery, Randomized controlled trial

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shatin Hospital
  • Pok Oi Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Self-regulated constraint-induced movement therapy

Constraint-induced movement therapy

Conventional occupational therapy

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Change from baseline in Lawton Instrumental Activities of Daily Living Scale after the intervention
Performance assessment on 8 daily tasks
Change from baseline in Lawton Instrumental Activities of Daily Living Scale at one month after the intervention completed
Performance assessment on 8 daily tasks
Change from baseline in Action Research Arm Test after the intervention
Performance assessment on arm function
Change from baseline in Action Research Arm Test at one month after the intervention completed
Performance assessment on arm function
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection after the intervention
Performance assessment on arm function
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection at one month after the intervention completed
Performance assessment on arm function

Secondary Outcome Measures

Change from baseline in Motor Activity Log-28 after the intervention
Self-reported assessment on daily function
Change from baseline in Motor Activity Log-28 at one month after the intervention completed
Self-reported assessment on daily function

Full Information

First Posted
June 18, 2015
Last Updated
June 26, 2015
Sponsor
University of Western Sydney
Collaborators
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02480140
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Sydney
Collaborators
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Self-regulation, Constraint-induced movement therapy, Stroke, Functional recovery, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-regulated constraint-induced movement therapy
Arm Type
Experimental
Arm 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.
Arm Title
Constraint-induced movement therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Conventional occupational therapy
Arm Type
Active Comparator
Arm Description
It involved therapist to demonstrate the adapted task performance followed by patient's practice under supervision.
Intervention Type
Other
Intervention Name(s)
Self-regulated constraint-induced movement therapy
Intervention Description
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
Intervention Name(s)
Constraint-induced movement therapy
Intervention Description
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
Intervention Name(s)
Conventional occupational therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Lawton Instrumental Activities of Daily Living Scale after the intervention
Description
Performance assessment on 8 daily tasks
Time Frame
Baseline and after the intervention (2 weeks)
Title
Change from baseline in Lawton Instrumental Activities of Daily Living Scale at one month after the intervention completed
Description
Performance assessment on 8 daily tasks
Time Frame
Baseline and one month after the intervention completed (1 month and 2 weeks)
Title
Change from baseline in Action Research Arm Test after the intervention
Description
Performance assessment on arm function
Time Frame
Baseline and after the intervention (2 weeks)
Title
Change from baseline in Action Research Arm Test at one month after the intervention completed
Description
Performance assessment on arm function
Time Frame
Baseline and one month after the intervention completed (1 month and 2 weeks)
Title
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection after the intervention
Description
Performance assessment on arm function
Time Frame
Baseline and after the intervention (2 weeks)
Title
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection at one month after the intervention completed
Description
Performance assessment on arm function
Time Frame
Baseline and one month after the intervention completed (1 month and 2 weeks)
Secondary Outcome Measure Information:
Title
Change from baseline in Motor Activity Log-28 after the intervention
Description
Self-reported assessment on daily function
Time Frame
Baseline and after the intervention (2 weeks)
Title
Change from baseline in Motor Activity Log-28 at one month after the intervention completed
Description
Self-reported assessment on daily function
Time Frame
Baseline and one month after the intervention completed (1 month and 2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen P.Y. Liu, PhD
Organizational Affiliation
University of Western Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shatin Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Pok Oi Hospital
City
Yuen Long
Country
Hong Kong

12. IPD Sharing Statement

Citations:
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background

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

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