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| Name | Class |
|---|---|
| Tuen Mun Hospital | OTHER_GOV |
| Kowloon Hospital, Hong Kong | OTHER |
| Guangzhou First People's Hospital | OTHER |
| Guangzhou Panyu Central Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Sham treatment | Sham Comparator | 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. |
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| Control | Other | Participants receive usual care only during the intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remind-to-move | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment-Upper Extremity Score | Hemiplegic arm motor impairment scale | Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure | Self-care performance scale | Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week |
| Motor Activity Log | Daily activity log |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth NK Fong, PhD | The Hong Kong Polytechnic University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21187201 | Background | 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. | |
| 23405025 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| OTHER |
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|
| Sham | Behavioral | 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 | Other | Participants received usual care |
|
| Change from 4-week to follow-ups at 8-week and 12-week |
| Accelerometry in wristwatch devices | Kinematic data recorded by the built-in accelerometers | Change from Baseline to 4-week |
| Box and Block Test | Hemiplegic arm laboratory dexterity test | Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week |
| Action Research Arm Test | Hemiplegic arm laboratory functional test | Change from Baseline to 4-week, and follow-ups at 8-week and 12-week |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |