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

October 31, 2016 updated by: The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:
  • Sensory cueing
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.
Other: Control
Participants received usual care
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 receive usual care only during the intervention period.
Other: Control
Participants received usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment-Upper Extremity Score
Time Frame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Hemiplegic arm motor impairment scale
Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure
Time Frame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Self-care performance scale
Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Motor Activity Log
Time Frame: Change from 4-week to follow-ups at 8-week and 12-week
Daily activity log
Change from 4-week to follow-ups at 8-week and 12-week
Accelerometry in wristwatch devices
Time Frame: Change from Baseline to 4-week
Kinematic data recorded by the built-in accelerometers
Change from Baseline to 4-week
Box and Block Test
Time Frame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Hemiplegic arm laboratory dexterity test
Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Action Research Arm Test
Time Frame: Change from Baseline to 4-week, and follow-ups at 8-week and 12-week
Hemiplegic arm laboratory functional test
Change from Baseline to 4-week, and follow-ups at 8-week and 12-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Guangzhou First People's Hospital
Kowloon Hospital, Hong Kong
Tuen Mun Hospital
Guangzhou Panyu Central Hospital

Investigators

  • Principal Investigator: Kenneth NK Fong, PhD, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRF/5608/12M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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