Development and Clinical Trials of a Rehabilitation Platform to Accelerate the Recovery of Patients With COVID Neuromotor Sequelae
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Barthel Index (BI)
研究概览
简要总结
Prolonged hospitalization in severe COVID-19 cases can lead to substantial muscle loss and functional deterioration. While rehabilitation is vital, conventional approaches encounter capacity constraints. Therefore, assessing the efficacy of robotic-assisted rehabilitation is crucial for post-COVID-19 fatigue syndrome patients, aiming to improve motor function and overall recovery. The study focuses on evaluating rehabilitation effectiveness in individuals with upper-extremity impairment using a hand exoskeleton-based robotic system.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 30 years old
- •Patients infected with COVID-19 and has received care at the Centro Hospitalario Benito Menni
- •Patients with acute or limited functional or strength impairment in at least one of the upper extremities
- •Patients who would complete a rehabilitation program and a series of patient reported outcome questionnaires and a follow up evaluation
- •Patients who give inform written consent.
排除标准
- •Presence of behavioral disorders
- •Dementia (loss of memory of cognitive functions)
- •Disorders of consciousness (confusional states and drowsiness)
- •Uncontrolled or severely limiting delusions and hallucinations
- •Infectious skin diseases
- •Rrisk of epileptic seizures due to COVID itself or prior to it
- •Severe visual impairments
- •Severe spasticity with a Modified Ashworth Scale >2, joint stiffness in the wrist and fingers
- •Pain with a score >8 on the Visual Analog Scale (VAS) during mobilization of the affected hand.
结局指标
主要结局
Barthel Index (BI)
时间窗: Baseline / 6 weeks
The Barthel Index (BI) modified by Granger et al is an ordinal scale for measuring the ability of an individual to independently execute 15 activities of daily living (ADL) related with mobility and self-care. BI aims to evaluate the degree of independence, with a final score ranging from 0 to 100, where 0 indicates full dependence.
Range of motion
时间窗: Baseline / 6 weeks
The range of motion was analyzed by goniometry measurements using the HandTutor® glove. It provides the active and passive movement of the participants fingers through sensors located in the front and back of the glove.
Functional Independence Measure (MIF)
时间窗: Baseline / 6 weeks
The Functional Independence Measure (MIF) was designed to provide an indicator of disability independent of a patient's impairment. The scale consists of 18 items to evaluate functional abilities in the area of communication, locomotion, self-care, social cognition, sphincter control and transfers. Each of these items is quantified utilizing a 7-point Likert scale. The total score, obtained by summing the individual item scores, spans from 18 to 126, with 18 denoting a state of complete dependence
SF-36 Health Questionnaire
时间窗: Baseline / 6 weeks
The SF-36 Health Questionnaire consists of 36 items designed to assess health-related quality of live. It encompasses eight scales, each comprising 2 to 10 items, which aimed to evaluate various health attributes. These scales include physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health.The score of each scale ranges from 0 to 100, with higher scores indicating a better health-related quality of life.
次要结局
- Semi-structured interview(Baseline)
研究者
Juan Carlos Fraile
Professor
University of Valladolid