Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke
1 other identifier
interventional
21
1 country
4
Brief Summary
The specific aims of this study will be to:
- 1.investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy (MT) versus a control intervention on motor and functional outcomes of stroke patients.
- 2.compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG).
- 3.determine the correlations between neural activation changes and clinical outcomes after AOT and MT.
- 4.identify who are the potential good responders to AOT and MT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2016
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedFebruary 1, 2019
January 1, 2019
1.2 years
August 1, 2016
January 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change scores of Fugl-Meyer Assessment
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
baseline, 3 weeks , 3 months
Secondary Outcomes (15)
Change scores of Modified Rankin Scale
baseline, 3 weeks , 3 months
Change scores of Box and Block Test
baseline, 3 weeks , 3 months
Change scores of Wolf Motor Function Test
baseline, 3 weeks , 3 months
Change scores of Medical Research Council scale
baseline, 3 weeks , 3 months
Change scores of Motor Activity Log
baseline, 3 weeks , 3 months
- +10 more secondary outcomes
Study Arms (3)
Action observation therapy (AOT)
EXPERIMENTALAction observation therapy (AOT)
Mirror therapy (MT)
EXPERIMENTALMirror therapy (MT)
Control group
ACTIVE COMPARATORCustomary bilateral UE training
Interventions
The patients were asked to observe everyday life actions of which they had motor experience or the actions belong to the motor repertoire of observers', they had better performance. The common categories of motor actions and tasks for stroke patients are selected in this study: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-extremity (UE) functional tasks practice.
The MT group will receive 60 minutes of upper-limb training in a mirror box. MT treatment activities will include AROM exercises (10 to 15 minutes), reaching movement or object manipulation (15 to 20 minutes), and functional tasks practice (30 minutes) in a mirror box.
The participants in this group will receive dose-matched customary bilateral UE training programs for 1 hour per session. The treatment protocol of control group will also include: (a) AROM exercises (10 to 15 minutes), (b) reaching movement or object manipulation (15 to 20 minutes), and (3) functional tasks practice (30 minutes).
Eligibility Criteria
You may qualify if:
- diagnosed as having a unilateral stroke
- to 6 months after stroke onset
- from 20 to 80 years of age
- a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
- able to follow the study instructions (measured by the Montreal Cognitive Assessment)
- capable of participating in therapy and assessment sessions
You may not qualify if:
- patients with global or receptive aphasia
- severe neglect
- major medical problems, or comorbidities that influenced UE usage or caused severe pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Taipei Tzu Chi hospital, Buddhist Tzu Chi Medical fundation
Taipei, 231, Taiwan
Cathay General Hospital (Taipei and Sijhi)
Taipei, Taiwan
Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare
Taoyuan District, 33351, Taiwan
Taoyuan Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Related Publications (2)
Hsieh YW, Lin YH, Zhu JD, Wu CY, Lin YP, Chen CC. Treatment Effects of Upper Limb Action Observation Therapy and Mirror Therapy on Rehabilitation Outcomes after Subacute Stroke: A Pilot Study. Behav Neurol. 2020 Jan 2;2020:6250524. doi: 10.1155/2020/6250524. eCollection 2020.
PMID: 32377266DERIVEDShih TY, Wu CY, Lin KC, Cheng CH, Hsieh YW, Chen CL, Lai CJ, Chen CC. Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial. Trials. 2017 Oct 4;18(1):459. doi: 10.1186/s13063-017-2205-z.
PMID: 28978349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Wei Hsieh, PhD
Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2016
First Posted
August 18, 2016
Study Start
August 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
February 1, 2019
Record last verified: 2019-01