Clinical trial NCT04983004: Effectiveness of Tele-rehabilitation Apply to Stroke Inpatient
Official title: Effectiveness of Telerehabilitation Applied to Post-stroke Hospitalized Patients -A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Postural Assessment Scale for Stroke Patients (PASS)
timeFrame: Change from Baseline at 3 weeks
Secondary outcomes:
measure: Functional ambulation category (FAC)
timeFrame: Change from Baseline at 3 weeks
measure: Modified barthel index (MBI)
timeFrame: Change from Baseline at 3 weeks
measure: Patient health questionnaire-9 (PHQ9)
timeFrame: Change from Baseline at 3 weeks
measure: Borg Rating of Perceived Exertion (RPE)
timeFrame: Change from Baseline at 3 weeks
measure: Satisfaction questionnaire
timeFrame: Every training session during 10 sessions, total sessions continued to 3 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Hsinchieh Lee, master
role: PRINCIPAL_INVESTIGATOR
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