Effectiveness of Tele-rehabilitation Apply to Stroke Inpatient

NCT04983004 | Completed

• 1 other identifier: N202107042
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

  Change from Baseline at 3 weeks

Secondary Outcomes (5)

• Functional ambulation category (FAC)

  Change from Baseline at 3 weeks

• Modified barthel index (MBI)

  Change from Baseline at 3 weeks

• Patient health questionnaire-9 (PHQ9)

  Change from Baseline at 3 weeks

• Borg Rating of Perceived Exertion (RPE)

  Change from Baseline at 3 weeks

• Satisfaction questionnaire

  Every training session during 10 sessions, total sessions continued to 3 weeks

Study Arms (2)

experimental group (tele-rehabilitation)

EXPERIMENTAL

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

control group (bedside rehabilitation)

ACTIVE COMPARATOR

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

Interventions

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.

experimental group (tele-rehabilitation)

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.

control group (bedside rehabilitation)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Location

Related Publications (16)

• 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.

  PMID: 25012864 BACKGROUND

• 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.

  PMID: 26940798 BACKGROUND

• 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.

  PMID: 20852420 BACKGROUND

• 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.

  PMID: 27386808 BACKGROUND

• 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.

  PMID: 22627983 BACKGROUND

• 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.

  PMID: 24449944 BACKGROUND

• 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.

  PMID: 26658151 BACKGROUND

• 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.

  PMID: 17981850 BACKGROUND

• 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.

  PMID: 17908575 BACKGROUND

• 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.

  PMID: 33284318 BACKGROUND

• 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.

  PMID: 32951302 BACKGROUND

• 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.

  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.

  PMID: 25217124 BACKGROUND

• 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.

  PMID: 29880211 BACKGROUND

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

  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.

  PMID: 12117760 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Hsinchieh Lee, master

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: August 20, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 29, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)