Effectiveness of Tele-rehabilitation Apply to Stroke Inpatient

Sponsor

Taipei Medical University Shuang Ho Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04983004

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: tele-rehabilitation Behavioral: bedside rehabilitation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 20, 2021

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Postural Assessment Scale for Stroke Patients (PASS) [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 Outcome Measures

Functional ambulation category (FAC) [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.
Modified barthel index (MBI) [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.
Patient health questionnaire-9 (PHQ9) [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).
Borg Rating of Perceived Exertion (RPE) [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.
Satisfaction questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Medical University Shuang Ho Hospital	New Taipei City		Taiwan

Sponsors and Collaborators

Taipei Medical University Shuang Ho Hospital

Investigators

Principal Investigator: Hsinchieh Lee, master, Taipei Medical University Shuang Ho Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Taipei Medical University Shuang Ho Hospital

ClinicalTrials.gov Identifier:

NCT04983004

Other Study ID Numbers:

N202107042

First Posted:

Jul 29, 2021

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jul 29, 2022