The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System for Continuum of Care in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change in measure of quality of life
研究概览
简要总结
The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS, Khymeia) compared to usual care treatment for patients with MS at home.
The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care training. The investigators will assess the effect of VRRS system on the quality of life, motor, and cognitive abilities. (Phase I) In the second phase of the present study we aim to evaluate the effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (lDLPFC) combined with VRRS compared to placebo tDCS stimulation combined with VRRS. The effects of the intervention patient-relevant outcomes will be assessed using a randomized controlled trial design with four groups. The investigators will assess the effect of VRRS system on patient-relevant outcomes motor, cognitive and participation. (Phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Multiple Sclerosis (RR and SP) based on McDonald criteria
- •Education ≥ 8 ages
- •Italian mother language
- •Right-handedness
- •Use of corticosteroids for three months prior to the study, having and no acute exacerbations of symptoms within three months of the study.
排除标准
- •Existence of visual acuity and acoustic perception problems, to prevent performance of VRRS activities
- •Relapses next to the time of enrolment (3 months)
- •EDSS > 6.5.
研究组 & 干预措施
VRRS Khymeia
The group will receive a kit home-based (a tablet home, an exercise equipment, access to a daily individualized training program).
The exercise program will be remotely charged by therapist on the patient's computer.
Each patient's performed session will be reviewed remotely by the therapist.
干预措施: VRRS Khymeia (Behavioral)
Usual care program
The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
干预措施: Usual care program (Behavioral)
VRRS Khymeia plus active tDCS
The group will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training
干预措施: VRRS Khymeia plus active tDCS (Behavioral)
VRRS Khymeia plus placebo tDCS
The group will receive 5 sessions of an individualized home-based VRRS training combined with placebo tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training
干预措施: VRRS Khymeia plus placebo tDCS (Behavioral)
结局指标
主要结局
Change in measure of quality of life
时间窗: Baseline up to 6 weeks and 6 months
Quality of life will be measured by 54-item Multiple Sclerosis Quality of Life (MSQOL-54) questionnaire There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In addition, there are 12 subscales: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. There are also two single-item measures: satisfaction with sexual function and change in health. Administration forms and scoring instructions can be downloaded (https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/MSQOL54\_995.pdf ). Higher values represent a better outcome
次要结局
- Change gross manual dexterity(Baseline up to 6 weeks and 6 months)
- Change in balance(Baseline up to 6 weeks and 6 months)
- Change cognitive status(Baseline up to 6 weeks and 6 months)
- Change in Behavioral (anxiety)(Baseline up to 6 weeks and 6 months)
- Change in Emotional Traits(Baseline up to 6 weeks and 6 months)
- Change in global cognitive status(Baseline up to 6 weeks and 6 months)
- Change in gait(Baseline up to 6 weeks and 6 months)
- Change in fatigue(Baseline up to 6 weeks and 6 months)
- Change in Behavioral (depression)(Baseline up to 6 weeks and 6 months)
研究者
Francesca Baglio
MD, researcher
Fondazione Don Carlo Gnocchi Onlus