NCT05713890招募中不适用
An Integrated and Home-based Motor Rehabilitation Combining Virtual Reality and Action Observation Treatment in People With Multiple Sclerosis: a Clinical and Neuroimaging Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in right hand Nine-hole peg test (9HPT)
研究概览
简要总结
Action Observation Treatment (AOT) is a rehabilitative strategy which has been proposed as a promising approach to improve motor performance in neurological conditions, including multiple sclerosis (MS).
In this clinical trial, the investigators aim to explore the role of a home-based AOT with virtual reality (VR) in improving upper limb motor function in people with MS (PwMS). The objectives are:
- To compare the effects of home-based VR-AOT versus VR-landscape observation (LO) on upper limb motor performance;
- To measure brain network functional changes (functional plasticity) and structural variations of gray matter (GM) and white matter (WM) (structural plasticity) using advanced magnetic resonance imaging (MRI) techniques following VR-AOT and VR-LO;
- To study the correlations between MRI changes and clinical improvements and the predictors of VR-AOT efficacy.
All participants will undergo treatment sessions for 3 weeks (5 consecutive days/week, total=15 sessions lasting 30 minutes each). Those in the VR-AOT group will observe, imagine and execute two upper limb motor tasks in each session. Those in the VR-LO group will perform the same tasks, but they will observe inanimate landscapes beforehand instead.
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
- Single (Outcomes Assessor)
盲法说明
The assessors (neurologists, physiotherapists and neuropsychologists) will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years;
- •Diagnosis of MS according to 2017 revised McDonald criteria;
- •Ability to understand the purpose and risks of the study and provide signed informed consent;
- •Ability to remotely perform VR-AOT;
- •Right pre-morbid handedness (EHI>50);
- •Muscle strength deficit involving the right upper limb (≥1 point decrease of MRC scale);
- •Presence of activity limitation of the right hand (need of adaptations, supervision or help by another person for the execution of daily living activities according to items 1-6 of the FIM);
- •EDSS score 2.0-7.0 (inclusive);
- •Cerebellar functional system score of the EDSS ≤1;
- •Baseline 9HPT score >21 seconds and <180 seconds.
排除标准
- •MRI contraindications;
- •Significant visual deficits not allowing to observe VR stimuli;
- •Moderate to severe pain disturbances (VAS≥4);
- •Concomitant neuro-psychiatric or systemic diseases (other than MS);
- •Clinical relapses or steroid treatment in the past 3 months;
- •Modification of symptomatic treatment or botulin toxin injection in the upper limb in the past 3 months;
- •Stable disease-modifying treatment for MS for ≤6 months;
- •Rehabilitation treatment in the past 3 months.
结局指标
主要结局
Change in right hand Nine-hole peg test (9HPT)
时间窗: Baseline, after 3 weeks of training and after a 3-month follow-up
Time required to complete the 9HPT, a measure of hand dexterity, with the right hand (average of two tests).
次要结局
- Change in finger tapping frequency(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in Expanded Disability Status Scale (EDSS)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in Symbol-Digit Modalities Test (SDMT)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Changes in regional gray matter volumes(Baseline and after 3 weeks of training)
- Change in left hand Nine-hole peg test (9HPT)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in Modified Ashworth Scale (MAS)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in items 1-6 of the Functional Independence Measure (FIM)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in Multiple Sclerosis Quality of Life-54 (MSQOL-54)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Changes in white matter microstructural architecture(Baseline and after 3 weeks of training)
- Changes in brain activation during an object manipulation task(Baseline and after 3 weeks of training)
- Change in hand grip strength(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in Paced Auditory Serial Addition Test (PASAT)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in Medical Research Council (MRC) scale(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in Modified Fatigue Impact Scale (MFIS)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in Arm Function in Multiple Sclerosis Questionnaire (AMSQ)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)(Baseline, after 3 weeks of training and after a 3-month follow-up)
- Change in global brain volume(Baseline and after 3 weeks of training)
- Changes in resting state functional connectivity(Baseline and after 3 weeks of training)
研究者
Prof. Massimo Filippi
Professor
IRCCS San Raffaele
研究点 (2)
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