"Remind-to-move" for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
"Remind-to-move" Using Wearable Devices in Home-based Treatment for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
1 other identifier
interventional
84
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Nov 2013
Typical duration for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedNovember 2, 2016
August 1, 2016
2.5 years
August 31, 2016
October 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Functional Independence Measure
Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Motor Activity Log
Change from 4-week to follow-ups at 8-week and 12-week
Accelerometry in wristwatch devices
Change from Baseline to 4-week
Box and Block Test
Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Action Research Arm Test
Change from Baseline to 4-week, and follow-ups at 8-week and 12-week
Study Arms (3)
Experimental
EXPERIMENTALParticipants 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.
Sham treatment
SHAM COMPARATORParticipants 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.
Control
OTHERParticipants receive usual care only during the intervention period.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Frst-time ischemic or hemorrhagic stroke confirmed by magnetic resonance imaging or X-ray computed tomography
- Unilateral hemispherical involvement
- Aged 18 or above
- Time since onset less than 6 months
- Functional Test for Hemiplegic Upper Extremity Hong Kong version (FTHUE-HK) ≥ 3 (maximum 7)
- Able to understand verbal instruction and follow one-step commands
- Modified Ashworth Scale (MAS) ≤ 2
- Mini-mental State Examination (MMSE) ≥ 19
- No complaint of excessive pain or swelling over hemiplegic arm
- Sensation on the affected wrist intact or with mild impairment only (National Institute of Health Stroke Scale=0 or 1).
You may not qualify if:
- Participating in any experimental or drug study
- Unable to give consent to participate
- Of inadequate balance as indicated by the inability to stand for at least 2 minutes with or without arm support
- Having history of botulinum toxin injection in 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hong Kong Polytechnic Universitylead
- Tuen Mun Hospitalcollaborator
- Kowloon Hospital, Hong Kongcollaborator
- Guangzhou First People's Hospitalcollaborator
- Guangzhou Panyu Central Hospitalcollaborator
Related Publications (2)
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.
PMID: 21187201BACKGROUNDFong 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.
PMID: 23405025BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth NK Fong, PhD
The Hong Kong Polytechnic University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2016
First Posted
November 2, 2016
Study Start
November 1, 2013
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
November 2, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share