Clinical trial NCT02952677: "Remind-to-move" for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
Official title: "Remind-to-move" Using Wearable Devices in Home-based Treatment for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Upper Extremity Hemiplegia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Tuen Mun Hospital
name: Kowloon Hospital, Hong Kong
name: Guangzhou First People's Hospital
name: Guangzhou Panyu Central Hospital
First posted: 2016-11-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity Score
timeFrame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Secondary outcomes:
measure: Functional Independence Measure
timeFrame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
measure: Motor Activity Log
timeFrame: Change from 4-week to follow-ups at 8-week and 12-week
measure: Accelerometry in wristwatch devices
timeFrame: Change from Baseline to 4-week
measure: Box and Block Test
timeFrame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
measure: Action Research Arm Test
timeFrame: Change from Baseline to 4-week, and follow-ups at 8-week and 12-week
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Kenneth NK Fong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fong KN, Lo PC, Yu YS, Cheuk CK, Tsang TH, Po AS, Chan CC. Effects of sensory cueing on voluntary arm use for patients with chronic stroke: a preliminary study. Arch Phys Med Rehabil. 2011 Jan;92(1):15-23. doi: 10.1016/j.apmr.2010.09.014.
citation: Fong KN, Yang NY, Chan MK, Chan DY, Lau AF, Chan DY, Cheung JT, Cheung HK, Chung RC, Chan CC. Combined effects of sensory cueing and limb activation on unilateral neglect in subacute left hemiplegic stroke patients: a randomized controlled pilot study. Clin Rehabil. 2013 Jul;27(7):628-37. doi: 10.1177/0269215512471959. Epub 2013 Feb 12.