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Effectiveness of Tele-rehabilitation Apply to Stroke Inpatient

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
tele-rehabilitation
bedside rehabilitation
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Taipei Medical University Shuang Ho Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group (tele-rehabilitation)

control group (bedside rehabilitation)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postural Assessment Scale for Stroke Patients (PASS)
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)
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)
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)
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)
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
Evaluation records after each treatment, and scores 1-4 according to the degree of satisfaction. The higher the score, the more satisfactory.

Full Information

First Posted
July 26, 2021
Last Updated
July 27, 2022
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04983004
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group (tele-rehabilitation)
Arm Type
Experimental
Arm Description
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.
Arm Title
control group (bedside rehabilitation)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
tele-rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
bedside rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Postural Assessment Scale for Stroke Patients (PASS)
Description
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
Time Frame
Change from Baseline at 3 weeks
Secondary Outcome Measure Information:
Title
Functional ambulation category (FAC)
Description
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.
Time Frame
Change from Baseline at 3 weeks
Title
Modified barthel index (MBI)
Description
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.
Time Frame
Change from Baseline at 3 weeks
Title
Patient health questionnaire-9 (PHQ9)
Description
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).
Time Frame
Change from Baseline at 3 weeks
Title
Borg Rating of Perceived Exertion (RPE)
Description
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.
Time Frame
Change from Baseline at 3 weeks
Title
Satisfaction questionnaire
Description
Evaluation records after each treatment, and scores 1-4 according to the degree of satisfaction. The higher the score, the more satisfactory.
Time Frame
Every training session during 10 sessions, total sessions continued to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsinchieh Lee, master
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25012864
Citation
Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
Results Reference
background
PubMed Identifier
26940798
Citation
Bini SA, Mahajan J. Clinical outcomes of remote asynchronous telerehabilitation are equivalent to traditional therapy following total knee arthroplasty: A randomized control study. J Telemed Telecare. 2017 Feb;23(2):239-247. doi: 10.1177/1357633X16634518. Epub 2016 Jul 9.
Results Reference
background
PubMed Identifier
20852420
Citation
Brochard S, Robertson J, Medee B, Remy-Neris O. What's new in new technologies for upper extremity rehabilitation? Curr Opin Neurol. 2010 Dec;23(6):683-7. doi: 10.1097/WCO.0b013e32833f61ce.
Results Reference
background
PubMed Identifier
27386808
Citation
Chen J, Jin W, Dong WS, Jin Y, Qiao FL, Zhou YF, Ren CC. Effects of Home-based Telesupervising Rehabilitation on Physical Function for Stroke Survivors with Hemiplegia: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2017 Mar;96(3):152-160. doi: 10.1097/PHM.0000000000000559.
Results Reference
background
PubMed Identifier
22627983
Citation
Chumbler NR, Quigley P, Li X, Morey M, Rose D, Sanford J, Griffiths P, Hoenig H. Effects of telerehabilitation on physical function and disability for stroke patients: a randomized, controlled trial. Stroke. 2012 Aug;43(8):2168-74. doi: 10.1161/STROKEAHA.111.646943. Epub 2012 May 24.
Results Reference
background
PubMed Identifier
24449944
Citation
Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4. Erratum In: Lancet. 2014 Jan 18;383(9913):218.
Results Reference
background
PubMed Identifier
26658151
Citation
Lee AC, Billings M. Telehealth Implementation in a Skilled Nursing Facility: Case Report for Physical Therapist Practice in Washington. Phys Ther. 2016 Feb;96(2):252-9. doi: 10.2522/ptj.20150079. Epub 2015 Dec 10.
Results Reference
background
PubMed Identifier
17981850
Citation
Leung SO, Chan CC, Shah S. Development of a Chinese version of the Modified Barthel Index-- validity and reliability. Clin Rehabil. 2007 Oct;21(10):912-22. doi: 10.1177/0269215507077286.
Results Reference
background
PubMed Identifier
17908575
Citation
Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
Results Reference
background
PubMed Identifier
33284318
Citation
Miller MJ, Pak SS, Keller DR, Barnes DE. Evaluation of Pragmatic Telehealth Physical Therapy Implementation During the COVID-19 Pandemic. Phys Ther. 2021 Jan 4;101(1):pzaa193. doi: 10.1093/ptj/pzaa193.
Results Reference
background
PubMed Identifier
32951302
Citation
Nakamori M, Imamura E, Tachiyama K, Kamimura T, Hayashi Y, Matsushima H, Okamoto H, Mizoue T, Wakabayashi S. Patient Health Questionnaire-9 predicts the functional outcome of stroke patients in convalescent rehabilitation ward. Brain Behav. 2020 Dec;10(12):e01856. doi: 10.1002/brb3.1856. Epub 2020 Sep 20.
Results Reference
background
Citation
Noorani, H., Brady, B., McGahan, L., Teasell, R., Skidmore, B., & Doherty, T. (2003). A clinical and economic review of stroke rehabilitation services. Technology Overview No, 10.
Results Reference
background
PubMed Identifier
25217124
Citation
Nordin N, Xie SQ, Wunsche B. Assessment of movement quality in robot- assisted upper limb rehabilitation after stroke: a review. J Neuroeng Rehabil. 2014 Sep 12;11:137. doi: 10.1186/1743-0003-11-137.
Results Reference
background
PubMed Identifier
29880211
Citation
Sarfo FS, Ulasavets U, Opare-Sem OK, Ovbiagele B. Tele-Rehabilitation after Stroke: An Updated Systematic Review of the Literature. J Stroke Cerebrovasc Dis. 2018 Sep;27(9):2306-2318. doi: 10.1016/j.jstrokecerebrovasdis.2018.05.013. Epub 2018 Jun 4.
Results Reference
background
Citation
Williams, N. (2017). The Borg rating of perceived exertion (RPE) scale. Occupational Medicine, 67(5), 404-405.
Results Reference
background
PubMed Identifier
12117760
Citation
Winters JM. Telerehabilitation research: emerging opportunities. Annu Rev Biomed Eng. 2002;4:287-320. doi: 10.1146/annurev.bioeng.4.112801.121923. Epub 2002 Mar 22.
Results Reference
background

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Effectiveness of Tele-rehabilitation Apply to Stroke Inpatient

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