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Completed

NCT Number: NCT04983004

Effectiveness of Tele-rehabilitation Apply to Stroke Inpatient

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tele-rehabilitation

Behavioral

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.

bedside rehabilitation

Behavioral

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2021
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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