Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Action observation therapy
Mirror therapy
Customary bilateral UE training
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, translational rehabilitation, mirror neuron system, action observation, mirror therapy, MEG
Eligibility Criteria
Inclusion Criteria:
- diagnosed as having a unilateral stroke
- 1 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
Exclusion Criteria:
- patients with global or receptive aphasia
- severe neglect
- major medical problems, or comorbidities that influenced UE usage or caused severe pain
Sites / Locations
- Taipei Tzu Chi hospital, Buddhist Tzu Chi Medical fundation
- Cathay General Hospital (Taipei and Sijhi)
- Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare
- Taoyuan Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Action observation therapy (AOT)
Mirror therapy (MT)
Control group
Arm Description
Action observation therapy (AOT)
Mirror therapy (MT)
Customary bilateral UE training
Outcomes
Primary Outcome Measures
Change scores of Fugl-Meyer Assessment
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
Secondary Outcome Measures
Change scores of Modified Rankin Scale
The Modified Rankin Scale is used to assess the degree of stroke disability.
Change scores of Box and Block Test
The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.
Change scores of Wolf Motor Function Test
The Wolf Motor Function Test was initially developed to assess the effect of constraint-induced movement therapy. Through the timed score, function score and grip score to quantify upper extremity motor function in people with stroke.
Change scores of Medical Research Council scale
The muscle power of the affected arm will be examined by the Medical Research Council scale.
Change scores of Motor Activity Log
The Motor Activity Log consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish 30 daily activities.
Change scores of Chedoke Arm and Hand Activity Inventory
The Chedoke Arm and Hand Activity Inventory is a new measurement development for assessing upper extremity function after stroke.
Change scores of Revised Nottingham Sensory Assessment
The Revised Nottingham Sensory Assessment includes the assessment of tactile sensation, kinesthetic sensation, and stereognosis and is a reliable measure of sensory function in stroke patients.
Change scores of ABILHAND questionnaire
The ABILHAND Questionnaire is a self-reported and Rasch-based scale that assesses patients' perceived difficulty in performing daily activities that require the use of the bilateral UE.
Change scores of Questionnaire Upon Mental Imagery
The short-form of Questionnaire Upon Mental Imagery is applied to assess patient's ability of mental imagery.
Change scores of Functional Independence Measure
The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.
Change scores of Stroke Impact Scale Version 3.0
The Stroke Impact Scale Version 3.0 is a patient-reported outcome to evaluate function, participation, and health-related quality of life of stroke survivors with sound psychometric properties.
Change scores of ActiGraph
The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The main outcome parameters will be the average intensity of physical activity (counts/minute), types of activity, and energy expenditure(Kcal) in real life.
Magnetoencephalography
Magnetoencephalography can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells
Change scores of Visual Analogue Scale for pain
Patient-reported pain on the Visual Analogue Scale
Change scores of Visual Analogue Scale for fatigue
Patient-reported fatigue on the Visual Analogue Scale
Full Information
NCT ID
NCT02871700
First Posted
August 1, 2016
Last Updated
January 30, 2019
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02871700
Brief Title
Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke
Official Title
Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The specific aims of this study will be to:
investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy (MT) versus a control intervention on motor and functional outcomes of stroke patients.
compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG).
determine the correlations between neural activation changes and clinical outcomes after AOT and MT.
identify who are the potential good responders to AOT and MT.
Detailed Description
In this 3-year study project, the investigators will design a comparative, randomized controlled trial to (1) investigate the treatment efficacy of AOT, 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, and (4) identify who are the potential good responders to AOT and MT. An estimated total of 90 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (a total of 15 sessions). Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up. For the MEG study, the investigators anticipate to recruit 12 to 15 patients in each group. The patients can still participate in this study to receive treatments and clinical evaluations even if they do not meet the MEG eligibility criteria or are not willing to participate in the MEG study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, translational rehabilitation, mirror neuron system, action observation, mirror therapy, MEG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Action observation therapy (AOT)
Arm Type
Experimental
Arm Description
Action observation therapy (AOT)
Arm Title
Mirror therapy (MT)
Arm Type
Experimental
Arm Description
Mirror therapy (MT)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Customary bilateral UE training
Intervention Type
Behavioral
Intervention Name(s)
Action observation therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mirror therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Customary bilateral UE training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change scores of Fugl-Meyer Assessment
Description
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
Time Frame
baseline, 3 weeks , 3 months
Secondary Outcome Measure Information:
Title
Change scores of Modified Rankin Scale
Description
The Modified Rankin Scale is used to assess the degree of stroke disability.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Box and Block Test
Description
The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Wolf Motor Function Test
Description
The Wolf Motor Function Test was initially developed to assess the effect of constraint-induced movement therapy. Through the timed score, function score and grip score to quantify upper extremity motor function in people with stroke.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Medical Research Council scale
Description
The muscle power of the affected arm will be examined by the Medical Research Council scale.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Motor Activity Log
Description
The Motor Activity Log consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish 30 daily activities.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Chedoke Arm and Hand Activity Inventory
Description
The Chedoke Arm and Hand Activity Inventory is a new measurement development for assessing upper extremity function after stroke.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Revised Nottingham Sensory Assessment
Description
The Revised Nottingham Sensory Assessment includes the assessment of tactile sensation, kinesthetic sensation, and stereognosis and is a reliable measure of sensory function in stroke patients.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of ABILHAND questionnaire
Description
The ABILHAND Questionnaire is a self-reported and Rasch-based scale that assesses patients' perceived difficulty in performing daily activities that require the use of the bilateral UE.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Questionnaire Upon Mental Imagery
Description
The short-form of Questionnaire Upon Mental Imagery is applied to assess patient's ability of mental imagery.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Functional Independence Measure
Description
The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of Stroke Impact Scale Version 3.0
Description
The Stroke Impact Scale Version 3.0 is a patient-reported outcome to evaluate function, participation, and health-related quality of life of stroke survivors with sound psychometric properties.
Time Frame
baseline, 3 weeks , 3 months
Title
Change scores of ActiGraph
Description
The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The main outcome parameters will be the average intensity of physical activity (counts/minute), types of activity, and energy expenditure(Kcal) in real life.
Time Frame
baseline, 3 weeks
Title
Magnetoencephalography
Description
Magnetoencephalography can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells
Time Frame
baseline, 3 weeks
Title
Change scores of Visual Analogue Scale for pain
Description
Patient-reported pain on the Visual Analogue Scale
Time Frame
baseline, 3 weeks
Title
Change scores of Visual Analogue Scale for fatigue
Description
Patient-reported fatigue on the Visual Analogue Scale
Time Frame
baseline, 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed as having a unilateral stroke
1 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
Exclusion Criteria:
patients with global or receptive aphasia
severe neglect
major medical problems, or comorbidities that influenced UE usage or caused severe pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Wei Hsieh, PhD
Organizational Affiliation
Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Tzu Chi hospital, Buddhist Tzu Chi Medical fundation
City
Taipei
ZIP/Postal Code
231
Country
Taiwan
Facility Name
Cathay General Hospital (Taipei and Sijhi)
City
Taipei
Country
Taiwan
Facility Name
Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare
City
Taoyuan
ZIP/Postal Code
33351
Country
Taiwan
Facility Name
Taoyuan Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32377266
Citation
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.
Results Reference
derived
PubMed Identifier
28978349
Citation
Shih 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.
Results Reference
derived
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Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke
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