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

The Hong Kong Polytechnic University84 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Upper Extremity Hemiplegia

Interventions

Remind-to-moveBEHAVIORAL

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.

ShamBEHAVIORAL

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.

ControlOTHER

Participants received usual care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Frst-time ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging or X-ray computed tomography 2. Unilateral hemispherical involvement 3. Aged 18 or above 4. Time since onset less than 6 months 5. Functional Test for Hemiplegic Upper Extremity Hong Kong version (FTHUE-HK) ≥ 3 (maximum 7) 6. Able to understand verbal instruction and follow one-step commands 7. Modified Ashworth Scale (MAS) ≤ 2 8. Mini-mental State Examination (MMSE) ≥ 19 9. No complaint of excessive pain or swelling over hemiplegic arm 10. Sensation on the affected wrist intact or with mild impairment only (National Institute of Health Stroke Scale=0 or 1). Exclusion Criteria: 1. Participating in any experimental or drug study 2. Unable to give consent to participate 3. Of inadequate balance as indicated by the inability to stand for at least 2 minutes with or without arm support 4. Having history of botulinum toxin injection in 3 months.

Outcomes

Primary Outcomes

Fugl-Meyer Assessment-Upper Extremity Score

Hemiplegic arm motor impairment scale

Time frame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week

Secondary Outcomes

Functional Independence Measure

Self-care performance scale

Time frame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week

Motor Activity Log

Daily activity log

Time frame: 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

Time frame: Change from Baseline to 4-week

Box and Block Test

Hemiplegic arm laboratory dexterity test

Time frame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week

Action Research Arm Test

Hemiplegic arm laboratory functional test

Time frame: Change from Baseline to 4-week, and follow-ups at 8-week and 12-week

Data from ClinicalTrials.gov

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