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Telerehabilitation During Pandemic Containment Measures of COVID19

U

Université de Sherbrooke

Status

Completed

Conditions

Stroke

Treatments

Other: upper limb training

Study type

Interventional

Funder types

Other

Identifiers

NCT04945356
MP-31-2021-3817

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

upper limb virtual training
Experimental group
Description:
6-week virtual training of the affected upper limb using the Physiotec application
Treatment:
Other: upper limb training

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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