Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04945356
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2021-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telerehabilitation During Pandemic Containment Measures of COVID19
Sponsor:
Université de Sherbrooke
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: