Telerehabilitation During Pandemic Containment Measures of COVID19

NCT04945356 | Completed

• 1 other identifier: MP-31-2021-3817
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

BACKGROUND: Although rehabilitation is effective in restoring function, many elderly individuals, especially those who have survived a stroke, are no longer receiving adequate rehabilitation services during the COVID19 pandemic due to containment measures. To overcome this problem, telerehabilitation is a promising avenue to deliver customized and personalized at-home therapy sessions while adhering to physical distancing guidelines. OBJECTIVES: The primary objective of this study is to evaluate the feasibility of using customized and personalized at-home therapy sessions using the Physiotec application for individuals with a stroke. A second objective is to measure the potential efficacy of the telerehabilitation intervention at improving function and quality of life based on standardized clinical measures and measures of improvement implemented in the Physiotec application. METHODS: We propose a non-randomized, single-group trial. Twenty-five individuals will be recruited on a voluntary basis. To be included, participants must 1) be ≥18 years old; 2) have a single unilateral stroke (≥ 6 months); 3) have minimal return of function in the affected upper limb; and 4) no longer be receiving rehabilitation treatments. Participants will receive a tablet containing the Physiotec application training program and TERA+, a telerehabilitation platform. The training program of the affected upper limb will last 6 weeks (90 minutes/week) and will be updated 3 times (weeks 1-3-5) by the therapist, using the TERA+ platform, based on the participant's functional capacity and progress, as measured by the app. Feasibility will be assessed by means of retention rate, adverse events, adherence to the telerehabilitation intervention, satisfaction with its use and with the exercise program. Efficacy will be assessed by several questionnaires on life habits, motor recovery and quality of life. RELEVANCE: This study will inform as to the optimal delivery of adapted rehabilitation services for stroke survivors that are currently not receiving optimal rehabilitation services because of the ongoing COVID19 pandemic. The results will serve to support in-home rehabilitation exercises aimed at promoting recovery, independent living and improving quality of life for stroke survivors.

Conditions

Stroke

Keywords

stroke; telerehabilitation; COVID19; function; upper limb; quality of life

Outcome Measures

Primary Outcomes (7)

• Retention rate to the telerehabilitation intervention

  the number of participants enrolled at the end of the study divided by the number of participants recruited at the beginning of the study

  in the week after the last session of telerehabilitation training

• Adherence to the telerehabilitation training program

  the number of telerehabilitation training sessions that participants took part in during the 6-week training program

  in the week after the last session of telerehabilitation training

• Adverse events related to the intensity of training assessed with the Borg scale embedded within the Physiotec application

  Adverse events related to the intensity of training will be tracked after each training session via the BORG scale (intensity of training should not be done at a score higher than 7/10)

  after each training session throughout the duration of the telerehabilitation training program

• Adverse events related to pain levels assessed with the visual analog scale embedded within the Physiotec application

  Adverse events related to pain will be tracked after each training session with a 0-10 visual analog scale for pain (training will be adjusted if pain score is greater than 7/10).

  after each training session throughout the duration of the telerehabilitation training program

• Participants' satisfaction with telerehabilitation assessed with the Telerehabilitation Satisfaction questionnaire

  Telerehabilitation Satisfaction questionnaire: this questionnaire contains 15 questions where the participants rate their satisfaction about the use of telerehabilitation on a Likert scale (from strongly agree to strongly disagree or undecided).

  in the week after the last session of telerehabilitation training

• Participants' satisfaction with the application assessed with the User Satisfaction questionnaire

  User Satisfaction questionnaire: this questionnaire contains 6 questions about the participants satisfaction about the application (from 1 = not at all to 5 = extremely)

  in the week after the last session of telerehabilitation training

• Participants' satisfaction with the exercise program assessed with the Health Care Satisfaction questionnaire

  Health Care Satisfaction questionnaire: this questionnaire comprises 26 questions about the participants feeling (from 1= not at all to 4= extremely) and the importance they give to different situations (from 1= not important to 4 = extremely important) related to the training program

  in the week after the last session of telerehabilitation training

Secondary Outcomes (8)

• Change in quality of life assessed with the 12-item Short Form Survey

  baseline and in the week after the last session of telerehabilitation training

• Change in life habits assessed with the LIFE-H 3.0 questionnaire

  baseline and in the week after the last session of telerehabilitation training

• Change in the quantity and quality of affected upper limb use assessed with the Motor Activity Log

  baseline and in the week after the last session of telerehabilitation training

• Change in reintegration to social activities assessed with the Reintegration to Normal Living Index

  baseline and in the week after the last session of telerehabilitation training

• Change in motor recovery of affected upper limb assessed with the Stroke Rehabilitation Assessment of Movement

  baseline and in the week after the last session of telerehabilitation training

Study Arms (1)

upper limb virtual training

EXPERIMENTAL

6-week virtual training of the affected upper limb using the Physiotec application

Other: upper limb training

Interventions

upper limb training OTHER

The 6-week exercise program will consist of evidence-based exercises covering the breadth and depth of rehabilitation interventions. The therapist will choose the appropriate exercises for each participant's level of function from more than 15,000 exercises implemented within the Physiotec app and developed by rehabilitation experts. Personalized upper limb exercises will be based on the therapist initial assessment of participants, using the TERA+ telerehabilitation platform, and their goals. After each training session, participants will have to rate their perceived level of effort on a Borg scale (/10). The Borg scores will be monitored by the therapist as a precautionary measure to ensure safety and appropriateness of intensity of exercises. Participants will be instructed to train at a target score of around 7/10 (somewhat hard) on the Borg scale.

upper limb virtual training

Eligibility Criteria

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

You may qualify if:

• be over 18 years of age;
• present a single unilateral stroke for more than 6 months;
• have a minimal motor return to the upper limb assessed visually via the visuo-conference platform;
• no longer receiving any in- or outpatient rehabilitation services.

You may not qualify if:

• severe spasticity that prevents movement of the affected limb (score \> 3 on the modified Ashworth scale);
• an orthopedic problem with the affected upper limb or lower limb;
• any neurological problem other than that arising from a stroke;
• cognitive impairment (a score ≤ 2/5 on the Mini-Cog Test);
• fall that has required physician evaluation within the past six months;
• other neurologic, neuromuscular, or orthopedic disease or comorbidities that would prevent exercise participation or increase participant risk;
• vision or hearing, communication, literacy or perceptual impairment that would interfere with app use as assessed by the study physical therapist during the screening process through a direct demonstration of the app and try out of the app

Sponsors & Collaborators

• Université de Sherbrooke: lead
• McGill University: collaborator
• Université du Québec à Chicoutimi: collaborator
• Université de Montréal: collaborator

Study Sites (3)

Université du Québec à Chicoutimi

Chicoutimi, Quebec, G7H 2B1, Canada

Location

McGill University

Montreal, Quebec, Canada

Location

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H4C4, Canada

Location

MeSH Terms

Conditions

Stroke; COVID-19

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher and principal investigator

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: June 30, 2021
• Study Start: October 28, 2020
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)