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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Control Device
    Intervention Desc: Participants received usual care
    ARM 1: Kind: Experimental
    Label: Experimental
    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 2: Kind: Experimental
    Label: Sham treatment
    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 3: Kind: Experimental
    Label: Control
    Description: Participants receive usual care only during the intervention period.
  • Sham Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Sham treatment
    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.
  • Remind-to-move Behavioral
    Other Names: Sensory cueing
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Experimental
    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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment-Upper Extremity Score Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Secondary Functional Independence Measure Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Secondary Motor Activity Log Change from 4-week to follow-ups at 8-week and 12-week
Secondary Accelerometry in wristwatch devices Change from Baseline to 4-week
Secondary Box and Block Test Change from Baseline to 4-week, plus follow-ups at 8-week and 12-week
Secondary Action Research Arm Test Change from Baseline to 4-week, and follow-ups at 8-week and 12-week

Sponsors