StrokeNCT02871700
Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke
A study testing Action observation therapy, Mirror therapy and Customary bilateral UE training in people with Stroke, run by Chang Gung Memorial Hospital at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Action observation therapy, Mirror therapy and Customary bilateral UE training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesTaiwan
- Study dates
- Aug 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with global or receptive aphasia
- severe neglect
- major medical problems, or comorbidities that influenced UE usage or caused severe pain
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Taipei Tzu Chi hospital, Buddhist Tzu Chi Medical fundation
Taipei, 231
Cathay General Hospital (Taipei and Sijhi)
Taipei
Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare
Taoyuan, 33351
Taoyuan Chang Gung Memorial Hospital
Taoyuan, 333
About this study
Official title: Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Action observation therapy, Mirror therapy, Customary bilateral UE training
- Keywords
- stroke, translational rehabilitation, mirror neuron system, action observation, mirror therapy, MEG
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation therapyBehavioural
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.
Mirror therapyBehavioural
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.
Customary bilateral UE trainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Action observation therapy (AOT) | Experimental | Action observation therapy (AOT) Receives: Behavioral: Action observation therapy |
| Mirror therapy (MT) | Experimental | Mirror therapy (MT) Receives: Behavioral: Mirror therapy |
| Control group | Active comparator | Customary bilateral UE training Receives: Behavioral: Customary bilateral UE training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Fugl-Meyer Assessment
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
Measured: baseline, 3 weeks , 3 months
Secondary outcomes (15)
Change scores of Modified Rankin Scale
The Modified Rankin Scale is used to assess the degree of stroke disability.
Measured: baseline, 3 weeks , 3 months
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.
Measured: baseline, 3 weeks , 3 months
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.
Measured: baseline, 3 weeks , 3 months
Change scores of Medical Research Council scale
The muscle power of the affected arm will be examined by the Medical Research Council scale.
Measured: baseline, 3 weeks , 3 months
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.
Measured: baseline, 3 weeks , 3 months
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.
Measured: baseline, 3 weeks , 3 months
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.
Measured: baseline, 3 weeks , 3 months
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.
Measured: baseline, 3 weeks , 3 months
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.
Measured: baseline, 3 weeks , 3 months
Change scores of Functional Independence Measure
The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.
Measured: baseline, 3 weeks , 3 months
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.
Measured: baseline, 3 weeks , 3 months
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.
Measured: baseline, 3 weeks
Magnetoencephalography
Magnetoencephalography can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells
Measured: baseline, 3 weeks
Change scores of Visual Analogue Scale for pain
Patient-reported pain on the Visual Analogue Scale
Measured: baseline, 3 weeks
Change scores of Visual Analogue Scale for fatigue
Patient-reported fatigue on the Visual Analogue Scale
Measured: baseline, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Wei Hsieh, PhD, Principal investigator, Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871700
- Sponsor's protocol ID
- 104-9173A3
- Status last verified
- Jan 2019
- First submitted
- 1 Aug 2016
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32377266Shih 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.
PubMed 28978349
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG
- ClinicalTrials.gov ID
- NCT02871700
- Acronym / sponsor ID
- 104-9173A3
- Conditions
- Stroke
- Keywords
- stroke, translational rehabilitation, mirror neuron system, action observation, mirror therapy, MEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Action observation therapy (AOT) | Experimental | Behavioral: Action observation therapyAction observation therapy (AOT) |
| Mirror therapy (MT) | Experimental | Behavioral: Mirror therapyMirror therapy (MT) |
| Control group | Active comparator | Behavioral: Customary bilateral UE trainingCustomary bilateral UE training |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- patients with global or receptive aphasia
- severe neglect
- major medical problems, or comorbidities that influenced UE usage or caused severe pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action observation therapyThe 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. | Behavioural | Action observation therapy (AOT) |
| Mirror therapyThe 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. | Behavioural | Mirror therapy (MT) |
| Customary bilateral UE trainingThe 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). | Behavioural | Control group |
Primary outcome
Change scores of Fugl-Meyer Assessment
Time frame: baseline, 3 weeks , 3 months
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
15 secondary outcomes
Change scores of Modified Rankin Scale
Time frame: baseline, 3 weeks , 3 months
Change scores of Box and Block Test
Time frame: baseline, 3 weeks , 3 months
Change scores of Wolf Motor Function Test
Time frame: baseline, 3 weeks , 3 months
Change scores of Medical Research Council scale
Time frame: baseline, 3 weeks , 3 months
Change scores of Motor Activity Log
Time frame: baseline, 3 weeks , 3 months
Change scores of Chedoke Arm and Hand Activity Inventory
Time frame: baseline, 3 weeks , 3 months
Change scores of Revised Nottingham Sensory Assessment
Time frame: baseline, 3 weeks , 3 months
Change scores of ABILHAND questionnaire
Time frame: baseline, 3 weeks , 3 months
Change scores of Questionnaire Upon Mental Imagery
Time frame: baseline, 3 weeks , 3 months
Change scores of Functional Independence Measure
Time frame: baseline, 3 weeks , 3 months
Change scores of Stroke Impact Scale Version 3.0
Time frame: baseline, 3 weeks , 3 months
Change scores of ActiGraph
Time frame: baseline, 3 weeks
Magnetoencephalography
Time frame: baseline, 3 weeks
Change scores of Visual Analogue Scale for pain
Time frame: baseline, 3 weeks
Change scores of Visual Analogue Scale for fatigue
Time frame: baseline, 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Derived from this study: PubMed 32377266Hsieh 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.
- Derived from this study: PubMed 28978349Shih 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.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Wei Hsieh, PhD principal investigator
Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, and Healthy Aging Research Center, Chang Gung University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation therapy, Mirror therapy and Customary bilateral UE training in people with Stroke, run by Chang Gung Memorial Hospital at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Fugl-Meyer Assessment (time frame: baseline, 3 weeks , 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871700, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.