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

Primary Purpose

Stroke, Upper Extremity Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remind-to-move
Sham
Control
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    Other

    Arm Label

    Experimental

    Sham treatment

    Control

    Arm Description

    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.

    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.

    Participants receive usual care only during the intervention period.

    Outcomes

    Primary Outcome Measures

    Fugl-Meyer Assessment-Upper Extremity Score
    Hemiplegic arm motor impairment scale

    Secondary Outcome Measures

    Functional Independence Measure
    Self-care performance scale
    Motor Activity Log
    Daily activity log
    Accelerometry in wristwatch devices
    Kinematic data recorded by the built-in accelerometers
    Box and Block Test
    Hemiplegic arm laboratory dexterity test
    Action Research Arm Test
    Hemiplegic arm laboratory functional test

    Full Information

    First Posted
    August 31, 2016
    Last Updated
    October 31, 2016
    Sponsor
    The Hong Kong Polytechnic University
    Collaborators
    Tuen Mun Hospital, Kowloon Hospital, Hong Kong, Guangzhou First People's Hospital, Guangzhou Panyu Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02952677
    Brief Title
    "Remind-to-move" for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
    Official Title
    "Remind-to-move" Using Wearable Devices in Home-based Treatment for Promoting Upper Extremity Recovery in Patients With Stroke After Subacute Discharge
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University
    Collaborators
    Tuen Mun Hospital, Kowloon Hospital, Hong Kong, Guangzhou First People's Hospital, Guangzhou Panyu Central Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Upper Extremity Hemiplegia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sham treatment
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    Participants receive usual care only during the intervention period.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Remind-to-move
    Other Intervention Name(s)
    Sensory cueing
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sham
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Participants received usual care
    Primary Outcome Measure Information:
    Title
    Fugl-Meyer Assessment-Upper Extremity Score
    Description
    Hemiplegic arm motor impairment scale
    Time Frame
    Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
    Secondary Outcome Measure Information:
    Title
    Functional Independence Measure
    Description
    Self-care performance scale
    Time Frame
    Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
    Title
    Motor Activity Log
    Description
    Daily activity log
    Time Frame
    Change from 4-week to follow-ups at 8-week and 12-week
    Title
    Accelerometry in wristwatch devices
    Description
    Kinematic data recorded by the built-in accelerometers
    Time Frame
    Change from Baseline to 4-week
    Title
    Box and Block Test
    Description
    Hemiplegic arm laboratory dexterity test
    Time Frame
    Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
    Title
    Action Research Arm Test
    Description
    Hemiplegic arm laboratory functional test
    Time Frame
    Change from Baseline to 4-week, and follow-ups at 8-week and 12-week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth NK Fong, PhD
    Organizational Affiliation
    The Hong Kong Polytechnic University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21187201
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23405025
    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. Epub 2013 Feb 12.
    Results Reference
    background

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

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