Effectiveness of Tele-rehabilitation Apply to Stroke Inpatient

July 27, 2022 updated by: Taipei Medical University Shuang Ho Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Taipei Medical University Shuang Ho Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group (tele-rehabilitation)

Each patient will go on a treatment with 10 sections, and each section is 15 or 30 minutes depends on patient's ability.

The intervention is used by the communication software to interact with each other in real time. The treatment plan and treatment method are set according to the individual's movement needs, and the individual's movement instructions are clearly given during treatment.
Behavioral: tele-rehabilitation
According to the pre-arranged case service schedule, the researcher is asked to push the computer and cart to the case ward for installation, and use the communication software to interact with each other in real time. The intervention method directly plays the recorded video to demonstrate the action according to the action needs of the case. The therapist can observe the video demonstration and the actual action execution of the case at the same time from the screen.
Active Comparator: control group (bedside rehabilitation)
Each patient will go on a treatment with 10 sections, and each section is 15 or 30 minutes depends on patient's ability. It is carried out by the bedside therapist. The treatment plan and treatment method are set according to the individual's movement needs, and the individual's movement instructions are clearly given during treatment.
Behavioral: bedside rehabilitation
The bedside therapist and the case work together to set an activity schedule. The case is asked to establish and record daily routine activities, provide basic exercise and activity schedules to avoid degradation and reduce the lack of active participation in activities. The protection is to wear personal protective equipment, including protective clothing, gloves, masks, and face shields, and wash hands and disinfect before and after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional ambulation category (FAC)
Time Frame: Change from Baseline at 3 weeks
Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. The score ranges from 0 to 5.
Change from Baseline at 3 weeks
Modified barthel index (MBI)
Time Frame: Change from Baseline at 3 weeks
Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. Total score ranges from 0-100.
Change from Baseline at 3 weeks
Patient health questionnaire-9 (PHQ9)
Time Frame: Change from Baseline at 3 weeks
The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Change from Baseline at 3 weeks
Borg Rating of Perceived Exertion (RPE)
Time Frame: Change from Baseline at 3 weeks
The Borg Rating of Perceived Exertion (RPE) scale will help you estimate how hard you're working (your activity intensity). Perceived exertion is how hard you think your body is exercising. Ratings on this scale are related to heart rate (how hard your heart is working to move blood through your body). The score range from 6-20.
Change from Baseline at 3 weeks
Satisfaction questionnaire
Time Frame: Every training session during 10 sessions, total sessions continued to 3 weeks
Evaluation records after each treatment, and scores 1-4 according to the degree of satisfaction. The higher the score, the more satisfactory.
Every training session during 10 sessions, total sessions continued to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202107042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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