StrokeNCT04441190
Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy
A study testing Digital Action Observation Therapy (Digital AOT), Digital Mirror Therapy (Digital MT) and Conventional Occupational Therapy in people with Stroke and Cerebrovascular Disorders, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
The specific study aims will be: 1. To develop the novel, digital, and interactive MSR system of arm and hand with integrated digital action observation therapy (AOT) and mirror therapy (MT). 2. To pilot usability testing for examining the feasibility of this new MSR system from the users' experiences and feedback. 3. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
- What is being tested?
- Digital Action Observation Therapy (Digital AOT), Digital Mirror Therapy (Digital MT) and Conventional Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesTaiwan
- Study dates
- 3 Aug 2020to 31 Jul 2021
- 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;
- aged from 20 to 80 years;
- a baseline score of the Fugl-Meyer Assessment in a range of 20 to 60;
- able to follow the instructions and able to provide user feedback verbally;
- without aphasia and neglect
- For therapists
Show all 14Show fewer
- holding an occupational therapist license
- Phase II: Validation of Clinical Treatment Efficacy
- diagnosed as having a unilateral stroke;
- at least 6 months after stroke onset;
- aged from 20 to 80 years;
- a baseline score of FMA in a range of 20 to 60;
- able to follow the study instructions;
- capable of participating in therapy and assessment sessions
Who cannot join
- global or receptive aphasia,
- severe neglect,
- major medical problems or comorbidities that have influenced upper-limb usage or caused severe pain
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, 24213
Taoyuan Chang Gung Memorial Hospital
Taoyuan City, 333
About this study
Official title: A Novel, Digital, and Interactive Multi-mode Stroke Rehabilitation System of Arm and Hand: Development and Validation of Clinical Efficacy
The specific study aims will be:
- To develop the novel, digital, and interactive MSR system of arm and hand with integrated digital action observation therapy (AOT) and mirror therapy (MT).
- To pilot usability testing for examining the feasibility of this new MSR system from the users' experiences and feedback.
- To examine the treatment effects of digital AOT, digital MT and a control intervention in patients with stroke by conducting a randomized controlled trial.
- To identify who will be the possible good responders to digital AOT and MT based on their baseline motor function and mental imagery abilities.
Read the detailed description
Phase I: Multi-mode stroke rehabilitation (MSR) System Development \& Usability Testing
Ten patients with stroke and 4 certified occupational therapists were recruited in this phase I study. During the pilot testing, each stroke patient will try to use each training mode of digital AOT and MT by the assistance of the therapist. At the end of the pilot testing, the patients and the therapists will be asked to complete the System Usability Scale and a self-designed questionnaire to assess the user experience and perspective about this new MSR system and their view of its suitability for stroke patients.
Phase II: Validation of Clinical Treatment Efficacy
This three-arm, single-blind, randomized controlled trial will investigate the treatment effects among the 3 groups of digital AOT, digital MT, and dose-matched control intervention. An estimated 60 patients with stroke will be recruited to participate in this phase II study. Each participant will receive a total of 15 training sessions (60 minutes per session) for 3 to 4 weeks. Clinical outcome measures will be conducted at baseline, immediately after treatment (the fourth week), and at 1 month follow-up after treatment.
- Being tested
- Digital Action Observation Therapy (Digital AOT), Digital Mirror Therapy (Digital MT), Conventional Occupational Therapy
- Keywords
- stroke, multi-mode rehabilitation, action observation, mirror therapy, digital image technology
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Action Observation Therapy (Digital AOT)Behavioural
The participants will be asked to observe videos and then practice what the participants observed.
Digital Mirror Therapy (Digital MT)Behavioural
The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
Conventional Occupational TherapyBehavioural
The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.
| Study group | Role | What they receive |
|---|---|---|
| Digital Action Observation Therapy (Digital AOT) | Experimental | The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks. Receives: Behavioral: Digital Action Observation Therapy (Digital AOT) |
| Digital Mirror Therapy (Digital MT) | Experimental | The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks. Receives: Behavioral: Digital Mirror Therapy (Digital MT) |
| Conventional Occupational Therapy | Active comparator | The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks. Receives: Behavioral: Conventional Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Fugl-Meyer Assessment
The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.
Measured: baseline, 4 weeks, 2 months
Change scores of Movement Imagery Questionnaire-Revised, Second Edition
The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.
Measured: baseline, 4 weeks, 2 months
Secondary outcomes (9)
Change scores of Chedoke Arm and Hand Activity Inventory
The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.
Measured: baseline, 4 weeks, 2 months
Change scores of Box and Block Test
The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.
Measured: baseline, 4 weeks, 2 months
Change scores of Revised Nottingham Sensory Assessment
The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.
Measured: baseline, 4 weeks, 2 months
Change scores of Barthel Index
The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.
Measured: baseline, 4 weeks, 2 months
Change scores of Motor Activity Log
The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living.
Measured: baseline, 4 weeks, 2 months
Change scores of the health state of EQ-5D-5L
The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state.
Measured: baseline, 4 weeks, 2 months
Change scores of the visual analogue scale (VAS) of EQ-5D-5L
The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.
Measured: baseline, 4 weeks, 2 months
Change of joint angles of OPAL wearable sensors
The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint angles. Joint angles of the shoulder, elbow, and wrist will be calculated.
Measured: baseline, 4 weeks, 2 months
Change of joint velocity of OPAL wearable sensors
The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint velocity. The angular velocity of shoulder, elbow, and wrist will be also collected.
Measured: baseline, 4 weeks, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start3 Aug 2020
- Primary completion11 May 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 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, College of Medicine, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441190
- Sponsor's protocol ID
- 201901885A3
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsieh YW, Lee MT, Hsu YC, Wu KY, Chen CC. Digital Mirror Therapy and Action Observation Therapy for Chronic Stroke: A Pilot Randomized Controlled Trial. Occup Ther Int. 2025 Mar 20;2025:8741362. doi: 10.1155/oti/8741362. eCollection 2025.
PubMed 40151488
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel, Digital, and Interactive Multi-mode Stroke Rehabilitation System of Arm and Hand: Development and Validation of Clinical Efficacy
- ClinicalTrials.gov ID
- NCT04441190
- Acronym / sponsor ID
- 201901885A3
- Keywords
- stroke, multi-mode rehabilitation, action observation, mirror therapy, digital image technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 22 Jun 2020 (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 develop the novel, digital, and interactive MSR system of arm and hand with integrated digital action observation therapy (AOT) and mirror therapy (MT).
- To pilot usability testing for examining the feasibility of this new MSR system from the users' experiences and feedback.
- To examine the treatment effects of digital AOT, digital MT and a control intervention in patients with stroke by conducting a randomized controlled trial.
- To identify who will be the possible good responders to digital AOT and MT based on their baseline motor function and mental imagery abilities.
Detailed description
Phase I: Multi-mode stroke rehabilitation (MSR) System Development \& Usability Testing
Ten patients with stroke and 4 certified occupational therapists were recruited in this phase I study. During the pilot testing, each stroke patient will try to use each training mode of digital AOT and MT by the assistance of the therapist. At the end of the pilot testing, the patients and the therapists will be asked to complete the System Usability Scale and a self-designed questionnaire to assess the user experience and perspective about this new MSR system and their view of its suitability for stroke patients.
Phase II: Validation of Clinical Treatment Efficacy
This three-arm, single-blind, randomized controlled trial will investigate the treatment effects among the 3 groups of digital AOT, digital MT, and dose-matched control intervention. An estimated 60 patients with stroke will be recruited to participate in this phase II study. Each participant will receive a total of 15 training sessions (60 minutes per session) for 3 to 4 weeks. Clinical outcome measures will be conducted at baseline, immediately after treatment (the fourth week), and at 1 month follow-up after treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Digital Action Observation Therapy (Digital AOT) | Experimental | Behavioral: Digital Action Observation Therapy (Digital AOT)The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks. |
| Digital Mirror Therapy (Digital MT) | Experimental | Behavioral: Digital Mirror Therapy (Digital MT)The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks. |
| Conventional Occupational Therapy | Active comparator | Behavioral: Conventional Occupational TherapyThe common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- diagnosed as having a unilateral stroke;
- aged from 20 to 80 years;
- a baseline score of the Fugl-Meyer Assessment in a range of 20 to 60;
- able to follow the instructions and able to provide user feedback verbally;
- without aphasia and neglect
Key exclusion criteria (3 listed)
- global or receptive aphasia,
- severe neglect,
- major medical problems or comorbidities that have influenced upper-limb 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 |
|---|---|---|
| Digital Action Observation Therapy (Digital AOT)The participants will be asked to observe videos and then practice what the participants observed. | Behavioural | Digital Action Observation Therapy (Digital AOT) |
| Digital Mirror Therapy (Digital MT)The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible. | Behavioural | Digital Mirror Therapy (Digital MT) |
| Conventional Occupational TherapyThe participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements. | Behavioural | Conventional Occupational Therapy |
Primary outcome
Change scores of Fugl-Meyer Assessment
Time frame: baseline, 4 weeks, 2 months
The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.
Change scores of Movement Imagery Questionnaire-Revised, Second Edition
Time frame: baseline, 4 weeks, 2 months
The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.
9 secondary outcomes
Change scores of Chedoke Arm and Hand Activity Inventory
Time frame: baseline, 4 weeks, 2 months
Change scores of Box and Block Test
Time frame: baseline, 4 weeks, 2 months
Change scores of Revised Nottingham Sensory Assessment
Time frame: baseline, 4 weeks, 2 months
Change scores of Barthel Index
Time frame: baseline, 4 weeks, 2 months
Change scores of Motor Activity Log
Time frame: baseline, 4 weeks, 2 months
Change scores of the health state of EQ-5D-5L
Time frame: baseline, 4 weeks, 2 months
Change scores of the visual analogue scale (VAS) of EQ-5D-5L
Time frame: baseline, 4 weeks, 2 months
Change of joint angles of OPAL wearable sensors
Time frame: baseline, 4 weeks, 2 months
Change of joint velocity of OPAL wearable sensors
Time frame: baseline, 4 weeks, 2 months
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 26 Nov 2021.
- Derived from this study: PubMed 40151488Hsieh YW, Lee MT, Hsu YC, Wu KY, Chen CC. Digital Mirror Therapy and Action Observation Therapy for Chronic Stroke: A Pilot Randomized Controlled Trial. Occup Ther Int. 2025 Mar 20;2025:8741362. doi: 10.1155/oti/8741362. eCollection 2025.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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, College of Medicine, Chang Gung University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Action Observation Therapy (Digital AOT), Digital Mirror Therapy (Digital MT) and Conventional Occupational Therapy in people with Stroke and Cerebrovascular Disorders, run by Chang Gung Memorial Hospital at 2 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 14 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 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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, 4 weeks, 2 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?
On the ClinicalTrials.gov record for NCT04441190, which also lists 1 linked publication.
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 26 Nov 2021.