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The specific study aims will be:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Action Observation Therapy (Digital AOT) | Behavioral | The participants will be asked to observe videos and then practice what the participants observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | baseline, 4 weeks, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 4 weeks, 2 months |
| Change scores of Box and Block Test |
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Phase I: Multi-mode stroke rehabilitation (MSR) System Development and Usability Testing
For stroke patients
Inclusion Criteria:
For therapists
Inclusion Criteria:
Phase II: Validation of Clinical Treatment Efficacy
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Wei Hsieh, PhD | Department of Occupational Therapy, College of Medicine, Chang Gung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Hospital, Ministry of Health and Welfare | New Taipei City | 24213 | Taiwan | |||
| Taoyuan Chang Gung Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40151488 | Derived | 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. |
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| Digital Mirror Therapy (Digital MT) | Behavioral | The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible. |
|
| Conventional Occupational Therapy | Behavioral | The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements. |
|
The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline, 4 weeks, 2 months |
| Taoyuan City |
| 333 |
| Taiwan |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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