NCT06685744招募中不适用
Effectiveness of TeleNEUROrehabilitation Systems for Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: the FIT4TeleNEURO Pragmatic Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 12
- 主要终点
- Change in static and dynamic balance as measured by the Mini-Best Test
研究概览
简要总结
The goal of the FIT4TeleNEURO pragmatic trial is to verify, in real-life care contexts, the superiority in terms of the effectiveness of early rehabilitation intervention with Telerehabilitation (TR) protocols (TR single Approach, task-oriented - TRsA; TR combined approach, task-oriented and impairment-oriented - TRcA) compared to conventional management (Educational treatment, ET).
The main questions it aims to answer are:
- Are Telerehabilitation protocols more effective than educational treatment?
- Is the TRcA treatment more effective than the TRsA? The study investigates the effects of rehabilitation treatment by comparing the two target cases (Multiple Sclerosis - MS and Parkinson's Diseases - PD).
Participants will be subjective to:
- 3 time-point of assessment (baseline, post-treatment and follow up) with motor, cognitive and quality-of-life measures
- A 5-weeks rehabilitation treatment (4 times/week)
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)
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of probable PD according to MDS criteria (Postuma et al., 2015) in staging between 1 and 3 on the Hoehn & Yahr scale (Goetz et al., 2004) or diagnosis of MS according to the criteria of MC Donald 2010 (Polman et al., 2011) with disability level at the Expanded Disability Status Scale EDSS (Kurtzke, 1983) ≤ 4.5;
- •age between 25 and 85 years;
- •preserved cognitive level at the Montreal Cognitive Assessment test (MoCA test >15.5) (Santangelo et al., 2015);
- •no rehabilitation program in place at the time of enrolment;
- •stable drug treatment (last three month) with L-Dopa or dopamine agonists (PD group) or Disease Modifying Therapies (DMTs) (MS group).
排除标准
- •presence of comorbidities that might prevent patients from undertaking a safe home program or determining clinical instability (i.e., severe orthopedic or severe cognitive deficits);
- •presence of major psychiatric complications or personality disorders;
- •presence of severe impairment of visual and/or acoustic perception;
- •falls resulting in injuries or more than 2 falls in the 6 months prior to recruitment (PD and MS groups).
- •pregnancy
- •relapse ongoing/at least 3 months since the last relapse (MS group);
- •presence of "frequent" freezing as recorded at the administration of Section II (daily life activity) of the UPDRS (score ≥ 3) (PD group);
- •EDSS-FS (cerebellar function) ≥ 3 (MS group).
结局指标
主要结局
Change in static and dynamic balance as measured by the Mini-Best Test
时间窗: Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment)
The Mini-BESTest aims to identify the disordered systems underlying the postural control responsible for poor functional balance. This tool is composed by 27 tasks (36 items in total) assessing bio-mechanical constraints, stability limits/verticality, anticipatory responses, postural responses, sensory orientation, and stability in gait. Each item is scored based on ordinal scale scoring from 0- 3 where 3 = best performances and 0 = worst performances. The total score is provided as a percentage. Higher scores are indicative of better performance.
次要结局
- Change in dynamic and static balance measured by the Fullerton Advanced Balance Scale - FAB(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in dynamic balance as measured by the modified Dynamic Gait Index - mDGI(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in perceived stability during activities of daily living as measured by the Activities Balance Confidence scale - ABC(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in perceived fatigue during activities of daily living measured by the Fatigue Severity Scale - FSS(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in functional lower limbs strength as measured by the Five Times Sit to Stand Test - 5xSTS(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in mobility and leg function performance as measured by the Timed 25 Foot Walk - T25FW(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in aerobic capacity and endurance as measured by the 6-Minute Walk Test - 6MWT(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in global cognitive functioning as measured by the Montreal Cognitive Assessment test - MoCA(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in visuoperceptual and attentional abilities as measured by the Trail Making Test - TMT parti A e B(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in visuoperceptual and attentional abilities as measured by the Symbol Digit Modalities Test - SDMT, Smith A., 1973; Nocentini U., 2006(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in the perceived level of disability as measured by the World Health Organization disability assessment schedule 2.0 - WHODAS 2.0(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
- Change in depressive symptoms as measured by the Beck Depression Inventory - BDI-II(Baseline, 5 weeks after baseline, and follow-up (3 months after the end of treatment))
研究者
研究点 (12)
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