A Novel, Digital, and Interactive Multi-mode Stroke Rehabilitation System of Arm and Hand: Development and Validation of Clinical Efficacy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Change scores of Fugl-Meyer Assessment
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Phase I: Multi-mode stroke rehabilitation (MSR) System Development and Usability Testing
- •For stroke patients
- •Inclusion Criteria:
- •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
- •Inclusion Criteria:
- •holding an occupational therapist license
- •Phase II: Validation of Clinical Treatment Efficacy
- •Inclusion Criteria:
- •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
Exclusion Criteria
- •global or receptive aphasia,
- •severe neglect,
- •major medical problems or comorbidities that have influenced upper-limb usage or caused severe pain
Arms & Interventions
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.
Intervention: Digital Action Observation Therapy (Digital AOT) (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.
Intervention: Digital Mirror Therapy (Digital MT) (Behavioral)
Conventional Occupational Therapy
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.
Intervention: Conventional Occupational Therapy (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change scores of Chedoke Arm and Hand Activity Inventory(baseline, 4 weeks, 2 months)
- Change scores of Box and Block Test(baseline, 4 weeks, 2 months)
- Change scores of Revised Nottingham Sensory Assessment(baseline, 4 weeks, 2 months)
- Change scores of Barthel Index(baseline, 4 weeks, 2 months)
- Change scores of Motor Activity Log(baseline, 4 weeks, 2 months)
- Change scores of the health state of EQ-5D-5L(baseline, 4 weeks, 2 months)
- Change scores of the visual analogue scale (VAS) of EQ-5D-5L(baseline, 4 weeks, 2 months)
- Change of joint angles of OPAL wearable sensors(baseline, 4 weeks, 2 months)
- Change of joint velocity of OPAL wearable sensors(baseline, 4 weeks, 2 months)