Effectiveness of Tele-rehabilitation Apply to Stroke Inpatient

NCT ID: NCT04983004

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-20

Study Completion Date

2022-07-01

Brief Summary

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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

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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

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

tele-rehabilitation

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

bedside rehabilitation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsinchieh Lee, master

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

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Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 25012864 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26940798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20852420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27386808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22627983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24449944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26658151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17981850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17908575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33284318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32951302 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 25217124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29880211 (View on PubMed)

Williams, N. (2017). The Borg rating of perceived exertion (RPE) scale. Occupational Medicine, 67(5), 404-405.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12117760 (View on PubMed)

Other Identifiers

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N202107042

Identifier Type: -

Identifier Source: org_study_id

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