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

The Hong Kong Polytechnic University

Status: Completed

Conditions: Stroke; Upper Extremity Hemiplegia

Treatments: Other: Control; Behavioral: Remind-to-move; Behavioral: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT02952677

GRF/5608/12M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 3 patient groups

Experimental

Experimental group

Description:

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.

Treatment:

Other: Control

Behavioral: Remind-to-move

Sham treatment

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham

Other: Control

Control

Other group

Description:

Participants receive usual care only during the intervention period.

Treatment:

Other: Control