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Effectiveness of a Wearable Device-based Assisted Post-stroke Rehabilitation System

NCT04997408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-05-17

No results posted yet for this study

Summary

Multidisciplinary rehabilitation facilitates functional recovery after stroke, and adherence to rehabilitation guidelines is associated with improved outcomes. We assessed the efficacy of a wearable device-assisted rehabilitation system in addition to conventional therapy compared to conventional therapy alone.

A total of 127 eligible acute stroke inpatients were enrolled. There were 76 males (59.8%). The mean age of the participants was 57.45 years; 63 and 64 participants were randomized to the WG and CG, respectively. Both groups showed significant improvements in mRS scores at 90 days (WG: -0.68 \[95% confidence interval (CI), -0.94 to -0.42\]; CG: -0.56 \[95% CI, -0.74 to -0.38\]; P\<0.0001), but only the WG had significant improvements between 30 and 90 days (-0.36; 95% CI, -0.72, -0.007; P=0.049). Both groups had significant improvements in secondary outcomes at 90 days, but there was no difference between groups.

Conditions

  • Post-Acute-Stroke Rehabilitation

Interventions

DEVICE

Customized exercise app

A Wearable Device-Based Assisted Post-Stroke Rehabilitation system

OTHER

In-person therapist-supervised rehabilitation

In-person therapist-supervised rehabilitation

Sponsors & Collaborators

  • National Central University, Taiwan

    collaborator OTHER

  • Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital, Taiwan

    collaborator UNKNOWN

  • Ministry of Health and Welfare, Taiwan

    collaborator OTHER_GOV

  • Landseed Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30
Completion
2018-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997408 on ClinicalTrials.gov