"Remind-to-move" for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental 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. |
Behavioral: Remind-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.
Other Names:
Other: Control
Participants received usual care
|
| Sham Comparator: Sham treatment 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. |
Behavioral: Sham
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.
Other: Control
Participants received usual care
|
| Other: Control Participants receive usual care only during the intervention period. |
Other: Control
Participants received usual care
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Frst-time ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging or X-ray computed tomography
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Unilateral hemispherical involvement
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Aged 18 or above
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Time since onset less than 6 months
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Functional Test for Hemiplegic Upper Extremity Hong Kong version (FTHUE-HK) ≥ 3 (maximum 7)
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Able to understand verbal instruction and follow one-step commands
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Modified Ashworth Scale (MAS) ≤ 2
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Mini-mental State Examination (MMSE) ≥ 19
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No complaint of excessive pain or swelling over hemiplegic arm
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Sensation on the affected wrist intact or with mild impairment only (National Institute of Health Stroke Scale=0 or 1).
Exclusion Criteria:
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Participating in any experimental or drug study
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Unable to give consent to participate
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Of inadequate balance as indicated by the inability to stand for at least 2 minutes with or without arm support
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Having history of botulinum toxin injection in 3 months.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Hong Kong Polytechnic University
- Tuen Mun Hospital
- Kowloon Hospital, Hong Kong
- Guangzhou First People's Hospital
- Guangzhou Panyu Central Hospital
Investigators
- Principal Investigator: Kenneth NK Fong, PhD, The Hong Kong Polytechnic University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- GRF/5608/12M