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Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mirror therapy
Bilateral arm training
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Randomized control trial, Mirror therapy, Bilateral arm training, Comparative efficacy research, Neurorehabilitation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • more than 6 months after onset of an ischemic or hemorrhage stroke
  • no excessive spasticity on all joints of the affected arm

Exclusion Criteria:

  • history of stroke or other neurologic, neuromuscular, or orthopedic disease
  • participation in other experimental rehabilitation or drug studies concurrent with this study

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mirror therapy

Bilateral arm training

Arm Description

Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.

Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.

Outcomes

Primary Outcome Measures

The efficacy of mirror therapy versus bilateral arm training on sensorimotor functions
Revised Nottingham Sensory Assessment and Fugl-Meyer Assessment will be used to measure sensorimotor functions. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.

Secondary Outcome Measures

The efficacy of mirror therapy versus bilateral arm training on motor performance
The Chedoke Arm and Hand Activity Inventory (CAHAI) will be used to measure arm and hand functions on real-life bilateral tasks. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training on motor performance.
The efficacy of mirror therapy versus bilateral arm training on motor performance
Motor Activity Log (MAL) will be used to measure self-perceived real-world use. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.
The efficacy of mirror therapy versus bilateral arm training on quality of life
Stroke Impact Scale Version 3.0 (SIS) will be used to measure patient reported quality of life and multidimensional stroke recovery. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.

Full Information

First Posted
September 9, 2015
Last Updated
September 1, 2020
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02548234
Brief Title
Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke
Official Title
Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke: a Pilot Randomized-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 11, 2015 (Actual)
Primary Completion Date
October 6, 2017 (Actual)
Study Completion Date
October 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study purpose is to compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients.
Detailed Description
Study background: Approximately 80% of stroke survivors have an upper and/or lower limb impairment (Barker 1997), and impairment of the arm explains up to 50% of the variance in functional limitation after stroke. Brain imaging research using magnetoencephalography found that mirror therapy combined with bilateral arm training could potentially aid stroke rehabilitation by normalizing an asymmetrical pattern of movement-related beta desynchronization in primary motor cortex. However, different neural mechanisms may cause different effect of motor control recovery after the two different approaches, which have yet to be studied. Study purpose:To compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients. Study method: This was a single-blind, randomized, comparative efficacy research. Sixty participants with chronic stroke will be recruited in the occupational therapy clinics at four hospitals and randomly assigned to the mirror therapy and bilateral arm training groups. The intervention will consist of 1.5 hrs/day, 5 days/wk for 4 wks, including 3 days of hospital-based therapy and 5 days of home practice. Primary outcomes were muscular properties (grip strength) and sensorimotor measurements. Secondary outcomes included measures of daily functions to gain insight about movement capabilities. The validity and reliability of all measurements have been proposed. Finally, the Mann-Whitney U test and the Fisher exact test will be used to compare the significant differences between the two approaches. The effect size of dependent variables will be reported also.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Randomized control trial, Mirror therapy, Bilateral arm training, Comparative efficacy research, Neurorehabilitation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mirror therapy
Arm Type
Experimental
Arm Description
Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.
Arm Title
Bilateral arm training
Arm Type
Experimental
Arm Description
Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.
Intervention Type
Other
Intervention Name(s)
Mirror therapy
Intervention Description
Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.
Intervention Type
Other
Intervention Name(s)
Bilateral arm training
Intervention Description
Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.
Primary Outcome Measure Information:
Title
The efficacy of mirror therapy versus bilateral arm training on sensorimotor functions
Description
Revised Nottingham Sensory Assessment and Fugl-Meyer Assessment will be used to measure sensorimotor functions. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.
Time Frame
within four weeks (plus or minus 3 days) after intervention
Secondary Outcome Measure Information:
Title
The efficacy of mirror therapy versus bilateral arm training on motor performance
Description
The Chedoke Arm and Hand Activity Inventory (CAHAI) will be used to measure arm and hand functions on real-life bilateral tasks. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training on motor performance.
Time Frame
within four weeks (plus or minus 3 days) after intervention
Title
The efficacy of mirror therapy versus bilateral arm training on motor performance
Description
Motor Activity Log (MAL) will be used to measure self-perceived real-world use. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.
Time Frame
within four weeks (plus or minus 3 days) after intervention
Title
The efficacy of mirror therapy versus bilateral arm training on quality of life
Description
Stroke Impact Scale Version 3.0 (SIS) will be used to measure patient reported quality of life and multidimensional stroke recovery. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.
Time Frame
within four weeks (plus or minus 3 days) after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: more than 6 months after onset of an ischemic or hemorrhage stroke no excessive spasticity on all joints of the affected arm Exclusion Criteria: history of stroke or other neurologic, neuromuscular, or orthopedic disease participation in other experimental rehabilitation or drug studies concurrent with this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keh-Chung Lin, ScD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22419334
Citation
Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD008449. doi: 10.1002/14651858.CD008449.pub2.
Results Reference
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PubMed Identifier
23419791
Citation
Wu CY, Huang PC, Chen YT, Lin KC, Yang HW. Effects of mirror therapy on motor and sensory recovery in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2013 Jun;94(6):1023-30. doi: 10.1016/j.apmr.2013.02.007. Epub 2013 Feb 15.
Results Reference
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PubMed Identifier
25064777
Citation
Samuelkamaleshkumar S, Reethajanetsureka S, Pauljebaraj P, Benshamir B, Padankatti SM, David JA. Mirror therapy enhances motor performance in the paretic upper limb after stroke: a pilot randomized controlled trial. Arch Phys Med Rehabil. 2014 Nov;95(11):2000-5. doi: 10.1016/j.apmr.2014.06.020. Epub 2014 Jul 23.
Results Reference
background
PubMed Identifier
24985386
Citation
Wolf A, Scheiderer R, Napolitan N, Belden C, Shaub L, Whitford M. Efficacy and task structure of bimanual training post stroke: a systematic review. Top Stroke Rehabil. 2014 May-Jun;21(3):181-96. doi: 10.1310/tsr2103-181.
Results Reference
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Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke

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