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Telerehabilitation During Pandemic Containment Measures of COVID19

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
upper limb training
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, telerehabilitation, COVID19, function, upper limb, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Université du Québec à Chicoutimi
  • McGill University
  • Centre de recherche sur le vieillissement

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

upper limb virtual training

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in quality of life assessed with the 12-item Short Form Survey
SF-12: this 12-question health survey assesses both physical and mental components of the respondent's current health status compared to their health status one month ago. It covers 8 domains such as limitations in physical activities because of health problems and bodily pain. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Change in life habits assessed with the LIFE-H 3.0 questionnaire
LIFE-H 3.0: this test includes 240 items and assesses the level of participation in daily activities and social roles. It also considers the degree of difficulty in carrying out tasks as well as the type of assistance required by the person. Each question is scored on a 0-9 scale where a score of 0 implies a total disruption of participation.
Change in the quantity and quality of affected upper limb use assessed with the Motor Activity Log
Motor Activity Log-14: this questionnaire assesses, on a 6-point ordinal scale, the use and quality of use of the affected upper limb in 14 everyday activities. A high score means that the participant perceives a greater use of his arm and a better quality of movement.
Change in reintegration to social activities assessed with the Reintegration to Normal Living Index
Reintegration to Normal Living Index: this questionnaire covers the following domains: indoor, community, distance mobility, self-care, daily activity, recreational and social activities, family role(s), personal relationships, presentation of self to others and general coping skills. Using 11 questions, it quantitatively assesses, on a 0-10 cm visual analogue scale, the degree to which individuals achieve reintegration into normal living. Each score is summed to provide a total score out of 110 points (adjusted back to 100) where a higher score indicates a better perception of reintegration
Change in motor recovery of affected upper limb assessed with the Stroke Rehabilitation Assessment of Movement
Stroke Rehabilitation Assessment of Movement: it is a performance-based measure that evaluates, on a 3-point ordinal scale, motor recovery at the affected upper limb. The total score for the upper limb section is 20 points with a higher score indicating a better motor recovery.
Change in range of motion at the affected upper limb assessed visually
Range of motion of the upper extremity will be visually estimated by a research assistant, using the TERA+ platform, for the shoulder (flexion), elbow (flexion & extension), forearm pronation/supination, wrist (extension & flexion) and finger (flexion & extension).
Participants' perceived improvement of the affected upper limb following training assessed with the Global Rating of Change Score questionnaire
Global Rating of Change Score: this questionnaire will assess the participant's perceived improvement in the function of his trained upper limb on a 7-point ordinal scale from 3 (very much improved) to -3 (very much worse)
Fear of COVID assessed with the Fear of COVID-19 scale
Fear of COVID-19 scale: this 7-item questionnaire will assess the perception of the participants about the COVID19 pandemic using a five-item Likert- type scale (from "strongly disagree" to "strongly agree"). The minimum score possible for each question is 1, and the maximum is 5. A total score is calculated by adding up each item score. The higher the score, the greater the fear of coronavirus-19 is.

Full Information

First Posted
June 24, 2021
Last Updated
April 26, 2022
Sponsor
Université de Sherbrooke
Collaborators
McGill University, Université du Québec à Chicoutimi, Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT04945356
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
McGill University, Université du Québec à Chicoutimi, Université de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, telerehabilitation, COVID19, function, upper limb, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
upper limb virtual training
Arm Type
Experimental
Arm Description
6-week virtual training of the affected upper limb using the Physiotec application
Intervention Type
Other
Intervention Name(s)
upper limb training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention rate to the telerehabilitation intervention
Description
the number of participants enrolled at the end of the study divided by the number of participants recruited at the beginning of the study
Time Frame
in the week after the last session of telerehabilitation training
Title
Adherence to the telerehabilitation training program
Description
the number of telerehabilitation training sessions that participants took part in during the 6-week training program
Time Frame
in the week after the last session of telerehabilitation training
Title
Adverse events related to the intensity of training assessed with the Borg scale embedded within the Physiotec application
Description
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)
Time Frame
after each training session throughout the duration of the telerehabilitation training program
Title
Adverse events related to pain levels assessed with the visual analog scale embedded within the Physiotec application
Description
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).
Time Frame
after each training session throughout the duration of the telerehabilitation training program
Title
Participants' satisfaction with telerehabilitation assessed with the Telerehabilitation Satisfaction questionnaire
Description
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).
Time Frame
in the week after the last session of telerehabilitation training
Title
Participants' satisfaction with the application assessed with the User Satisfaction questionnaire
Description
User Satisfaction questionnaire: this questionnaire contains 6 questions about the participants satisfaction about the application (from 1 = not at all to 5 = extremely)
Time Frame
in the week after the last session of telerehabilitation training
Title
Participants' satisfaction with the exercise program assessed with the Health Care Satisfaction questionnaire
Description
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
Time Frame
in the week after the last session of telerehabilitation training
Secondary Outcome Measure Information:
Title
Change in quality of life assessed with the 12-item Short Form Survey
Description
SF-12: this 12-question health survey assesses both physical and mental components of the respondent's current health status compared to their health status one month ago. It covers 8 domains such as limitations in physical activities because of health problems and bodily pain. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time Frame
baseline and in the week after the last session of telerehabilitation training
Title
Change in life habits assessed with the LIFE-H 3.0 questionnaire
Description
LIFE-H 3.0: this test includes 240 items and assesses the level of participation in daily activities and social roles. It also considers the degree of difficulty in carrying out tasks as well as the type of assistance required by the person. Each question is scored on a 0-9 scale where a score of 0 implies a total disruption of participation.
Time Frame
baseline and in the week after the last session of telerehabilitation training
Title
Change in the quantity and quality of affected upper limb use assessed with the Motor Activity Log
Description
Motor Activity Log-14: this questionnaire assesses, on a 6-point ordinal scale, the use and quality of use of the affected upper limb in 14 everyday activities. A high score means that the participant perceives a greater use of his arm and a better quality of movement.
Time Frame
baseline and in the week after the last session of telerehabilitation training
Title
Change in reintegration to social activities assessed with the Reintegration to Normal Living Index
Description
Reintegration to Normal Living Index: this questionnaire covers the following domains: indoor, community, distance mobility, self-care, daily activity, recreational and social activities, family role(s), personal relationships, presentation of self to others and general coping skills. Using 11 questions, it quantitatively assesses, on a 0-10 cm visual analogue scale, the degree to which individuals achieve reintegration into normal living. Each score is summed to provide a total score out of 110 points (adjusted back to 100) where a higher score indicates a better perception of reintegration
Time Frame
baseline and in the week after the last session of telerehabilitation training
Title
Change in motor recovery of affected upper limb assessed with the Stroke Rehabilitation Assessment of Movement
Description
Stroke Rehabilitation Assessment of Movement: it is a performance-based measure that evaluates, on a 3-point ordinal scale, motor recovery at the affected upper limb. The total score for the upper limb section is 20 points with a higher score indicating a better motor recovery.
Time Frame
baseline and in the week after the last session of telerehabilitation training
Title
Change in range of motion at the affected upper limb assessed visually
Description
Range of motion of the upper extremity will be visually estimated by a research assistant, using the TERA+ platform, for the shoulder (flexion), elbow (flexion & extension), forearm pronation/supination, wrist (extension & flexion) and finger (flexion & extension).
Time Frame
baseline and in the week after the last session of telerehabilitation training
Title
Participants' perceived improvement of the affected upper limb following training assessed with the Global Rating of Change Score questionnaire
Description
Global Rating of Change Score: this questionnaire will assess the participant's perceived improvement in the function of his trained upper limb on a 7-point ordinal scale from 3 (very much improved) to -3 (very much worse)
Time Frame
in the week after the last session of telerehabilitation training
Title
Fear of COVID assessed with the Fear of COVID-19 scale
Description
Fear of COVID-19 scale: this 7-item questionnaire will assess the perception of the participants about the COVID19 pandemic using a five-item Likert- type scale (from "strongly disagree" to "strongly agree"). The minimum score possible for each question is 1, and the maximum is 5. A total score is calculated by adding up each item score. The higher the score, the greater the fear of coronavirus-19 is.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Université du Québec à Chicoutimi
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 2B1
Country
Canada
Facility Name
McGill University
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Centre de recherche sur le vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H4C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Telerehabilitation During Pandemic Containment Measures of COVID19

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