"Remind-to-move" for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge

Stroke Clinical Trial

Official title:

"Remind-to-move" Using Wearable Devices in Home-based Treatment for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952677
• Other study ID #: GRF/5608/12M
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: October 31, 2016
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Research Committee of The Hong Kong Polytechnic University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia
• Stroke
• Upper Extremity Hemiplegia

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Guangzhou First Municipal People’s Hospital, Guangzhou Panyu Central Hospital, Kowloon Hospital, Hong Kong, Tuen Mun Hospital

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Functional Independence Measure	Self-care performance scale	Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week	No
Secondary	Motor Activity Log	Daily activity log	Change from 4-week to follow-ups at 8-week and 12-week	No
Secondary	Accelerometry in wristwatch devices	Kinematic data recorded by the built-in accelerometers	Change from Baseline to 4-week	No
Secondary	Box and Block Test	Hemiplegic arm laboratory dexterity test	Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week	No
Secondary	Action Research Arm Test	Hemiplegic arm laboratory functional test	Change from Baseline to 4-week, and follow-ups at 8-week and 12-week	No