Stroke Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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