StrokeNCT03246139
Action Observation, Imagery and Execution for Stroke Rehabilitation
A study testing Action observation, imagery & execution and Action observation in people with Stroke, run by Chang Gung Memorial Hospital at 4 sites in Taiwan.
Trial summary
The specific study aims will be: 1. To investigate the short- and long-term treatment effects of action observation, imagery, and execution therapy (AOIE) compared with an action observation therapy (AO) group and a control treatment group as controls on different aspects of outcomes in patients with stroke. 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, imagery & execution and Action observation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesTaiwan
- Study dates
- 23 Aug 2017to 31 Jul 2020
- 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 12 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
- 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
- Additionally, if patients have no metal implants, no head traumas or neurosurgical operations, and can perform MEG motor tasks, the participants can additionally participate in the MEG assessment.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Taipei medical university hospital
Taipei, 110
Taipei Medical University Shuang Ho Hospital
Taipei, 23561
Taoyuan Chang Gung Memorial Hospital
Taoyuan City, 333
Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare
Taoyuan City, 3351
About this study
Official title: Action Observation, Imagery and Execution as a New Intervention Strategy for Stroke Rehabilitation: Short- and Long-term Treatment Effects and Neural Mechanism
The specific study aims will be:
- To investigate the short- and long-term treatment effects of action observation, imagery, and execution therapy (AOIE) compared with an action observation therapy (AO) group and a control treatment group as controls on different aspects of outcomes in patients with stroke.
- To examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients.
- To examine the correlations between AOIE-induced brain activation changes and the clinical efficacy of AOIE.
- To identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.
Read the detailed description
The investigators propose a 3-year randomized controlled trial to (1) investigate the short- and long-term treatment efficacy of AOIE, action observation alone, versus control treatment on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and activation changes after the 3 interventions by using an advanced brain imaging technique, magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes, and (4) identify who are the good responders to the AOIE therapy. An estimated total of 96 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive 1 of the 3 interventions for 3 weeks (a total of 15 sessions). Clinical outcome measures will be conducted at baseline, immediately after treatment (3 weeks), and at 3 months follow-up. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks). For the MEG study, The investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging evaluation because of the specific eligibility criteria and high costs of MEG. The patients can still participate in the study, receiving rehabilitation therapy and clinical evaluations, even if the participants will not be included in the MEG study.
- Conditions
- Stroke
- Being tested
- Action observation, imagery & execution, Action observation, Control treatment
- Keywords
- stroke, neurorehabilitation, mirror neuron system, action observation, motor imagery, 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, imagery & executionBehavioural
The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.
Action observationBehavioural
The participants will be asked to observe videos and then practice what the participants observed.
Control treatmentBehavioural
The participants will receive UE training without watching videos or imagining movements/tasks.
| Study group | Role | What they receive |
|---|---|---|
| Action observation, imagery & execution | Experimental | Not described Receives: Behavioral: Action observation, imagery & execution |
| Action observation | Active comparator | Not described Receives: Behavioral: Action observation |
| Control treatment | Active comparator | Not described Receives: Behavioral: Control treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 Fugl-Meyer Assessment
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
Measured: baseline, 3 weeks , 3 months
Secondary outcomes (8)
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 Chedoke Arm and Hand Activity Inventory (CAHAI)
The CAHAI measures the upper-limb motor function after stroke.
Measured: baseline, 3 weeks , 3 months
Change scores of Movement Imagery Questionnaire, revised second version
The MIQ-RS will be applied to assess patient's ability of motor 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 physical intensity measured by activity monitors
The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of average intensity of physical activity (counts/minute) will be reported.
Measured: baseline, 3 weeks , 3 months
Change scores of energy expenditure measured by activity monitors
The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of energy expenditure(Kcal) will be reported.
Measured: baseline, 3 weeks , 3 months
Change scores of Stroke Impact Scale (SIS) 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
Magnetoencephalography (MEG)
Magnetoencephalography (MEG) can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks).
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 posted11 Aug 2017
- Study start23 Aug 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 17 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
- NCT03246139
- Sponsor's protocol ID
- 201602056A3
- Other IDs
- N201705016
- Status last verified
- Jun 2020
- First submitted
- 3 Aug 2017
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Observation, Imagery and Execution as a New Intervention Strategy for Stroke Rehabilitation: Short- and Long-term Treatment Effects and Neural Mechanism
- ClinicalTrials.gov ID
- NCT03246139
- Acronym / sponsor ID
- 201602056A3
- Conditions
- Stroke
- Keywords
- stroke, neurorehabilitation, mirror neuron system, action observation, motor imagery, MEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 11 Aug 2017 (actual)
- 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 study aims will be:
- To investigate the short- and long-term treatment effects of action observation, imagery, and execution therapy (AOIE) compared with an action observation therapy (AO) group and a control treatment group as controls on different aspects of outcomes in patients with stroke.
- To examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients.
- To examine the correlations between AOIE-induced brain activation changes and the clinical efficacy of AOIE.
- To identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.
Detailed description
The investigators propose a 3-year randomized controlled trial to (1) investigate the short- and long-term treatment efficacy of AOIE, action observation alone, versus control treatment on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and activation changes after the 3 interventions by using an advanced brain imaging technique, magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes, and (4) identify who are the good responders to the AOIE therapy. An estimated total of 96 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive 1 of the 3 interventions for 3 weeks (a total of 15 sessions). Clinical outcome measures will be conducted at baseline, immediately after treatment (3 weeks), and at 3 months follow-up. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks). For the MEG study, The investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging evaluation because of the specific eligibility criteria and high costs of MEG. The patients can still participate in the study, receiving rehabilitation therapy and clinical evaluations, even if the participants will not be included 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, imagery & execution | Experimental | Behavioral: Action observation, imagery & execution |
| Action observation | Active comparator | Behavioral: Action observation |
| Control treatment | Active comparator | Behavioral: Control treatment |
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 12 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
Key exclusion criteria (4 listed)
- patients with global or receptive aphasia,
- severe neglect
- major medical problems, or comorbidities that influenced UE usage or caused severe pain
- Additionally, if patients have no metal implants, no head traumas or neurosurgical operations, and can perform MEG motor tasks, the participants can additionally participate in the MEG assessment.
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, imagery & executionThe participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed. | Behavioural | Action observation, imagery & execution |
| Action observationThe participants will be asked to observe videos and then practice what the participants observed. | Behavioural | Action observation |
| Control treatmentThe participants will receive UE training without watching videos or imagining movements/tasks. | Behavioural | Control treatment |
Primary outcome
Change scores of Modified Rankin Scale
Time frame: baseline, 3 weeks , 3 months
The Modified Rankin Scale is used to assess the degree of stroke disability.
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.
8 secondary outcomes
Change scores of Box and Block Test
Time frame: baseline, 3 weeks , 3 months
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
Time frame: baseline, 3 weeks , 3 months
Change scores of Movement Imagery Questionnaire, revised second version
Time frame: baseline, 3 weeks , 3 months
Change scores of Functional Independence Measure
Time frame: baseline, 3 weeks , 3 months
Change scores of physical intensity measured by activity monitors
Time frame: baseline, 3 weeks , 3 months
Change scores of energy expenditure measured by activity monitors
Time frame: baseline, 3 weeks , 3 months
Change scores of Stroke Impact Scale (SIS) Version 3.0
Time frame: baseline, 3 weeks , 3 months
Magnetoencephalography (MEG)
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 27 Jan 2021.
- Individual participant dataSharing planned: No
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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, imagery & execution and Action observation 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 4 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 27 Jan 2021. 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 Modified Rankin Scale (time frame: baseline, 3 weeks , 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2021.