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Clinical Trials/NCT04983004
NCT04983004
Completed
N/A

Effectiveness of Telerehabilitation Applied to Post-stroke Hospitalized Patients -A Randomized Controlled Trial

Taipei Medical University Shuang Ho Hospital1 site in 1 country24 target enrollmentAugust 20, 2021
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Taipei Medical University Shuang Ho Hospital
Enrollment
24
Locations
1
Primary Endpoint
Postural Assessment Scale for Stroke Patients (PASS)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Our study is aimed to explore the differences in effects on the motor function and general condition after telerehabilitation for inpatients with stroke.

Detailed Description

Background: Most patients after stroke suffer from poor motor recovery and difficulty in performing activities of daily living. Early intervention has a better prognosis for them. However, patients may miss the regular rehabilitation programs due to Covid-19. Tele-rehabilitation could be a substitution for regular rehabilitation in epidemic situation, by which patients after stroke could have a functional improvement in upper limb motions, ADLs, and complex activities. Furthermore, there is no evidence yet of the effectiveness of telerehabilitation applied to inpatients after stroke. Purposes: This study is aimed to know if telerehabilitation could improve the motor function and general condition in inpatients after stroke and to explore the intervention methods for telerehabilitation. Methods: Inpatients after stroke would be recruited from a hospital of a medical university in Northern Taiwan. They will be divided into the telerehabilitation group (n = 12) and the bedside rehabilitation group (n = 12). Each patient will go on treatment in 10 sections, and each section is 15 or to 30 minutes. A single-blinded evaluator will do the pre-and post-evaluation during the treatment. The evaluations include the Postural Assessment Scale for Stroke Patients (PASS), Functional ambulation category (FAC), Modified Barthel index (MBI), Patient health questionnaire-9 (PHQ9), and Borg Rating of Perceived Exertion (RPE). In the end, a satisfaction questionnaire will be given. Data analysis: Nonparametric tests will be used in the comparison of the pre-and post-evaluation data intergroup. The analysis will be carried out using SPSS Statistic (v20.0) and α \< .05. Key words: tele-rehabilitation, stroke, inpatients

Registry
clinicaltrials.gov
Start Date
August 20, 2021
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Taipei Medical University Shuang Ho Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • First time stroke survivors with hemiplegia after 5 days;
  • Participant or his/her caregiver have ability to hold and reposition the smartphone, tablet, or notebook, and understand verbal instructions by therapists;
  • Participant could sit at the bedside, or his/her caregiver could company aside during session.

Exclusion Criteria

  • Patients are older than 85 years old and less than 20 years old;
  • The specific movement functions considered in this study are affected by any reasons of other neurological, cardiopulmonary, cancers or musculoskeletal system disease.

Outcomes

Primary Outcomes

Postural Assessment Scale for Stroke Patients (PASS)

Time Frame: Change from Baseline at 3 weeks

PASS is a postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture.The PASS consists of a 4-point scale where items are scored from 0 - 3. The total score ranges from 0 - 36

Secondary Outcomes

  • Functional ambulation category (FAC)(Change from Baseline at 3 weeks)
  • Modified barthel index (MBI)(Change from Baseline at 3 weeks)
  • Patient health questionnaire-9 (PHQ9)(Change from Baseline at 3 weeks)
  • Borg Rating of Perceived Exertion (RPE)(Change from Baseline at 3 weeks)
  • Satisfaction questionnaire(Every training session during 10 sessions, total sessions continued to 3 weeks)

Study Sites (1)

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