Telerehabilitation During Pandemic Containment Measures of COVID19

NCT ID: NCT04945356

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

upper limb virtual training

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

Group Type: EXPERIMENTAL

upper limb training

Intervention Type: 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.

Interventions

upper limb training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. be over 18 years of age;

2. present a single unilateral stroke for more than 6 months;

3. have a minimal motor return to the upper limb assessed visually via the visuo-conference platform;

4. no longer receiving any in- or outpatient rehabilitation services.

Exclusion Criteria

1. severe spasticity that prevents movement of the affected limb (score > 3 on the modified Ashworth scale);

2. an orthopedic problem with the affected upper limb or lower limb;

3. any neurological problem other than that arising from a stroke;

4. cognitive impairment (a score ≤ 2/5 on the Mini-Cog Test);

5. fall that has required physician evaluation within the past six months;

6. other neurologic, neuromuscular, or orthopedic disease or comorbidities that would prevent exercise participation or increase participant risk;

7. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

Université du Québec à Chicoutimi

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Marie-Hélène Milot

researcher and principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Université du Québec à Chicoutimi

Chicoutimi, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

MP-31-2021-3817

Identifier Type: -

Identifier Source: org_study_id