Remind-to-move for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge

Study Overview
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Brief Summary
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This is a multi-centered randomized controlled trial to investigate the effects of Remind-to-Move (RTM) using wearable devices at home for promoting upper extremity recovery in stroke patients after discharge from subacute hospitals.

Detailed Description
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This is a proof-of-principle study to investigate the effects of Remind-to-Move (RTM) using wearable devices at home for promoting upper extremity recovery in stroke patients after discharge from subacute hospitals. A multi-center, parallel-group, randomized controlled trial with blinded assessment was carried out in four hospitals. Eighty-four eligible participants who had suffered from stroke with less than 6 months and could slightly move their arms were randomly allocated to either an experimental, sham, or control group stratified by hemiplegic arm functional levels. Patients in the experimental group were treated by RTM using wearable devices, 3 consecutive hours daily, for 4 weeks. The sham group used sham devices. The control group received the usual care. A masked assessor evaluated the participants at 0, 4th, 8th and 12th weeks. Outcome measures included arm function tests, motor activity log, movement amount and percentage recorded by wearable devices. All patients allocated to treatment were included in intention-to-treat analysis.

Official Title
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Remind-to-move Using Wearable Devices in Home-based Treatment for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge

Conditions
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Stroke, Upper Extremity Hemiplegia

Intervention / Treatment
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* Behavioral: Remind-to-move
* Behavioral: Sham
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Frst-time ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging or X-ray computed tomography Unilateral hemispherical involvement Aged 18 or above Time since onset less than 6 months Functional Test for Hemiplegic Upper Extremity Hong Kong version (FTHUE-HK) ≥ 3 (maximum 7) Able to understand verbal instruction and follow one-step commands Modified Ashworth Scale (MAS) ≤ 2 Mini-mental State Examination (MMSE) ≥ 19 No complaint of excessive pain or swelling over hemiplegic arm Sensation on the affected wrist intact or with mild impairment only (National Institute of Health Stroke Scale=0 or 1). Exclusion Criteria: Participating in any experimental or drug study Unable to give consent to participate Of inadequate balance as indicated by the inability to stand for at least 2 minutes with or without arm support Having history of botulinum toxin injection in 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Participants receive Remind-to-move by means of vibration emitted through sensory cueing wristwatch devices, 3 consecutive hours daily, for 4 weeks, as well as usual care during the intervention period.They are also encouraged to use their arms as much as possible and the accelerometer built-in the device record the arm movement during daily activities. | Behavioral: Remind-to-move<br>* Participants were required to wear sensory cueing wristwatch devices with vibration emitted on the affected arm for 3 consecutive hours daily, for a total of 4 weeks, at any time during the day, and received usual care as well.<br>* Other names: Sensory cueing;Other: Control<br>* Participants received usual care<br>|
| Sham Comparator: Sham treatment<br>Participants wear sham wristwatch devices but without vibration cueing, 3 consecutive hours daily, for 4 weeks, as well as usual care during the intervention period. They are also encouraged to use their arms as much as possible and the accelerometer built-in the device record the arm movement during daily activities. | Behavioral: Sham<br>* Participants were required to wear sensory cueing wristwatch devices without vibration emitted on the affected arm for 3 consecutive hours daily, for a total of 4 weeks, at any time during the day, and received usual care as well.<br>Other: Control<br>* Participants received usual care<br>|
| Other: Control<br>Participants receive usual care only during the intervention period. | Other: Control<br>* Participants received usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment-Upper Extremity Score | Hemiplegic arm motor impairment scale | Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure | Self-care performance scale | Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week | 
| Motor Activity Log | Daily activity log | Change from 4-week to follow-ups at 8-week and 12-week | 
| Accelerometry in wristwatch devices | Kinematic data recorded by the built-in accelerometers | Change from Baseline to 4-week | 
| Box and Block Test | Hemiplegic arm laboratory dexterity test | Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week | 
| Action Research Arm Test | Hemiplegic arm laboratory functional test | Change from Baseline to 4-week, and follow-ups at 8-week and 12-week |