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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Retention rate to the telerehabilitation intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Retention rate to the telerehabilitation intervention
时间窗: in the week after the last session of telerehabilitation training
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
时间窗: in the week after the last session of telerehabilitation training
the number of telerehabilitation training sessions that participants took part in during the 6-week training program
Participants' satisfaction with telerehabilitation assessed with the Telerehabilitation Satisfaction questionnaire
时间窗: in the week after the last session of telerehabilitation training
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).
Adverse events related to the intensity of training assessed with the Borg scale embedded within the Physiotec application
时间窗: after each training session throughout the duration of the telerehabilitation training program
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
时间窗: after each training session throughout the duration of the telerehabilitation training program
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 the application assessed with the User Satisfaction questionnaire
时间窗: in the week after the last session of telerehabilitation training
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
时间窗: in the week after the last session of telerehabilitation training
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
次要结局
- Change in motor recovery of affected upper limb assessed with the Stroke Rehabilitation Assessment of Movement(baseline and in the week after the last session of telerehabilitation training)
- Change in quality of life assessed with the 12-item Short Form Survey(baseline and in the week after the last session of telerehabilitation training)
- Change in life habits assessed with the LIFE-H 3.0 questionnaire(baseline and in the week after the last session of telerehabilitation training)
- Change in reintegration to social activities assessed with the Reintegration to Normal Living Index(baseline and in the week after the last session of telerehabilitation training)
- Change in range of motion at the affected upper limb assessed visually(baseline and in the week after the last session of telerehabilitation training)
- Change in the quantity and quality of affected upper limb use assessed with the Motor Activity Log(baseline and in the week after the last session of telerehabilitation training)
- Participants' perceived improvement of the affected upper limb following training assessed with the Global Rating of Change Score questionnaire(in the week after the last session of telerehabilitation training)
- Fear of COVID assessed with the Fear of COVID-19 scale(baseline)
研究者
Marie-Hélène Milot
researcher and principal investigator
Université de Sherbrooke