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. To examine the treatment effects of digital AOT, digital MT and a control intervention in patients with stroke by conducting a randomized controlled trial. 4. To identify who will be the possible good responders to digital AOT and MT based on their baseline motor function and mental imagery abilities.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
32
The participants will be asked to observe videos and then practice what the participants observed.
The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan
Taoyuan Chang Gung Memorial Hospital
Taoyuan, Taiwan
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.
Time frame: 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.
Time frame: baseline, 4 weeks, 2 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 4 weeks, 2 months
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