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StrokeNCT02952677

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

A study testing Remind-to-move in people with Stroke and Upper Extremity Hemiplegia, run by The Hong Kong Polytechnic University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Upper Extremity Hemiplegia
What is being tested?
Remind-to-move
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
No sites listed yet
Study dates
Nov 2013to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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).

Who cannot join

  • 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.

About this study

Official title: "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.

Read the 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.

Being tested
Remind-to-move, Sham, Control
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remind-to-moveBehavioural

    Also called Sensory cueing

    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.

  • ShamBehavioural

    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.

  • ControlOther

    Participants received usual care

Study groups in NCT02952677
Study groupRoleWhat they receive
ExperimentalExperimentalParticipants 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.
Receives: Behavioral: Remind-to-move; Other: Control
Sham treatmentSham 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.
Receives: Behavioral: Sham; Other: Control
ControlOtherParticipants receive usual care only during the intervention period.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment-Upper Extremity Score

    Hemiplegic arm motor impairment scale

    Measured: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week

Secondary outcomes (5)

  1. Functional Independence Measure

    Self-care performance scale

    Measured: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week

  2. Motor Activity Log

    Daily activity log

    Measured: Change from 4-week to follow-ups at 8-week and 12-week

  3. Accelerometry in wristwatch devices

    Kinematic data recorded by the built-in accelerometers

    Measured: Change from Baseline to 4-week

  4. Box and Block Test

    Hemiplegic arm laboratory dexterity test

    Measured: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week

  5. Action Research Arm Test

    Hemiplegic arm laboratory functional test

    Measured: Change from Baseline to 4-week, and follow-ups at 8-week and 12-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2016 (estimated)
  2. Study startNov 2013
  3. Primary completionMay 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952677
Sponsor's protocol ID
GRF/5608/12M
Status last verified
Aug 2016
First submitted
31 Aug 2016
Last updated
2 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21187201

  • 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.

    PubMed 23405025

Questions about this trial

What is this clinical trial studying?

A study testing Remind-to-move in people with Stroke and Upper Extremity Hemiplegia, run by The Hong Kong Polytechnic University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment-Upper Extremity Score (time frame: Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02952677, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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