Clinical trial NCT04945356: Telerehabilitation During Pandemic Containment Measures of COVID19
Official title: The Use of Telerehabilitation to Improve Function and Quality of Life for People in the Chronic Phase After Stroke During Pandemic Containment Measures of COVID19 : a Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
telerehabilitation
COVID19
function
upper limb
quality of life
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: McGill University
name: Université du Québec à Chicoutimi
name: Université de Montréal
First posted: 2021-06-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Retention rate to the telerehabilitation intervention
timeFrame: in the week after the last session of telerehabilitation training
measure: Adherence to the telerehabilitation training program
timeFrame: in the week after the last session of telerehabilitation training
measure: Adverse events related to the intensity of training assessed with the Borg scale embedded within the Physiotec application
timeFrame: after each training session throughout the duration of the telerehabilitation training program
measure: Adverse events related to pain levels assessed with the visual analog scale embedded within the Physiotec application
timeFrame: after each training session throughout the duration of the telerehabilitation training program
measure: Participants' satisfaction with telerehabilitation assessed with the Telerehabilitation Satisfaction questionnaire
timeFrame: in the week after the last session of telerehabilitation training
measure: Participants' satisfaction with the application assessed with the User Satisfaction questionnaire
timeFrame: in the week after the last session of telerehabilitation training
measure: Participants' satisfaction with the exercise program assessed with the Health Care Satisfaction questionnaire
timeFrame: in the week after the last session of telerehabilitation training
Secondary outcomes:
measure: Change in quality of life assessed with the 12-item Short Form Survey
timeFrame: baseline and in the week after the last session of telerehabilitation training
measure: Change in life habits assessed with the LIFE-H 3.0 questionnaire
timeFrame: baseline and in the week after the last session of telerehabilitation training
measure: Change in the quantity and quality of affected upper limb use assessed with the Motor Activity Log
timeFrame: baseline and in the week after the last session of telerehabilitation training
measure: Change in reintegration to social activities assessed with the Reintegration to Normal Living Index
timeFrame: baseline and in the week after the last session of telerehabilitation training
measure: Change in motor recovery of affected upper limb assessed with the Stroke Rehabilitation Assessment of Movement
timeFrame: baseline and in the week after the last session of telerehabilitation training
measure: Change in range of motion at the affected upper limb assessed visually
timeFrame: baseline and in the week after the last session of telerehabilitation training
measure: Participants' perceived improvement of the affected upper limb following training assessed with the Global Rating of Change Score questionnaire
timeFrame: in the week after the last session of telerehabilitation training
measure: Fear of COVID assessed with the Fear of COVID-19 scale
timeFrame: baseline
Other outcomes:
Locations:
city: Chicoutimi
country: Canada
facility: Université du Québec à Chicoutimi
state: Quebec
city: Montréal
country: Canada
facility: McGill University
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement
state: Quebec
Study officials:
References: