"Remind-to-move" for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
NCT ID: NCT02952677
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2013-11-30
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Control
Participants received usual care
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.
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.
Control
Participants received usual care
Control
Participants receive usual care only during the intervention period.
Control
Participants received usual care
Interventions
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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.
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.
Control
Participants received usual care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Tuen Mun Hospital
OTHER_GOV
Kowloon Hospital, Hong Kong
OTHER
Guangzhou First People's Hospital
OTHER
Guangzhou Panyu Central Hospital
OTHER
The Hong Kong Polytechnic University
OTHER
Responsible Party
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Principal Investigators
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Kenneth NK Fong, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
References
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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.
Other Identifiers
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GRF/5608/12M
Identifier Type: -
Identifier Source: org_study_id