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

Not Applicable

Completed

• Conditions: Upper Extremity Hemiplegia; Stroke
• Interventions: Other: Control; Behavioral: Remind-to-move; Behavioral: Sham

• Registration Number: NCT02952677
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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

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 Timeline

• Study Start: 2013-11
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2016-08
• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-10-31
• Last Update Submitted: 2016-10-31
• Study First Posted: 2016-11-02
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Participants receive usual care only during the intervention period.
Experimental	Remind-to-move	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.
Sham treatment	Sham	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.
Experimental	Control	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.
Sham treatment	Control	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.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment-Upper Extremity Score	Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week	Hemiplegic arm motor impairment scale

Secondary Outcome Measures

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