Stroke, Upper Extremity Hemiplegia
Conditions
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.
Interventions
BEHAVIORALRemind-to-move
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.
BEHAVIORALSham
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.
OTHERControl
Participants received usual care
Sponsors
Tuen Mun Hospital
Kowloon Hospital, Hong Kong
Guangzhou First People's Hospital
Guangzhou Panyu Central Hospital
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed