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Completed

NCT Number: NCT02952677

"Remind-to-move" 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Upper Extremity Hemiplegia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Sensory cueing

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Functional Independence Measure

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

    Self-care performance scale

  2. Motor Activity Log

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

    Daily activity log

  3. Accelerometry in wristwatch devices

    Time frame: Change from Baseline to 4-week

    Kinematic data recorded by the built-in accelerometers

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 2, 2016
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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