DANCE REhabilitation Experience (DANCEREX-DTx): Protocol for a Randomized Controlled Trial on Effectiveness of Digital Therapeutics in Chronic Neurological Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 3
- 主要终点
- Adherence to treatment
研究概览
简要总结
The goal of this clinical trial is to test a new digital therapeutic solution which combines a holistic, multidimensional rehabilitation program based on dance and music with an innovative motivational system (DANCEREX-DTx) in Chronic Neurological Disorders (Multiple Sclerosis and pre-Mild Cognitive Impairment - MCI/ MCI at risk of Alzheimer's Disease). The main questions it aims to answer are 1] efficacy of the digital therapeutic solution in terms of adherence, clinical/functional measures, quality of life and surrogate measures; 2] usability and acceptability of the system.
Participants will be randomized (with an allocation ratio of 2:2:1) into the experimental group (DANCEREX - 24 sessions of multidimensional dance-based program integrated with an innovative motivational system), active comparator group (24 sessions of multidimensional dance-based program) and placebo group (24 sessions of educational program). Researchers will compare the experimental group to the other two groups to see if a digital therapeutic solution integrating a multidimensional dance-based program and motivational system is effective in increasing adherence to rehabilitation treatment.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 85 years (adult and older adult);
- •education equal to or more than five years
- •agreement to participate with the signature of the informed consent form;
- •clinical diagnosis of Multiple Sclerosis (MS) according to the 2017 revised criteria of MC Donald - Expanded Disability Status Scale (EDSS) score equal or less than 4.5, R-R disease course, freedom from relapses, and steroid treatment for at least one month, OR clinical diagnosis of pre-Mild Cognitive Impairment - MCI (Subjective Memory Complaints and/or Subjective Cognitive Complaints)/MCI at risk of Alzheimer's Disease with the Clinical Dementia Rating (CDR) scale equal or less than 0.5
- •Normal score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test > 15.5 Santangelo et al., 2015)
排除标准
- •presence of comorbidities that prevent patients from undertaking a safe home program (e.g., balance problems, history of falls in the past 6 months, use of assistive devices for deambulation)
- •presence of overt hearing/visual impairment
- •for the MCI group, the absence of a caregiver/study partner able to support the participant;
- •no living in one's own home;
- •for the MS group, score in cerebellum function at EDSS greater than 3
研究组 & 干预措施
DANCEREX Treatment
Multidimensional dance-based program with motivational support integrated into applied game. The treatment will last 12 weeks with a frequency of two sessions a week, each lasting about 45 min.
干预措施: DANCEREX-DTx (Device)
Multidimensional dance-based program
Multidimensional dance-based program without motivational support. The treatment will last 12 weeks with a frequency of two sessions a week, each lasting about 45 min.
干预措施: Multidimensional dance-based program (Device)
Educational Program
Educational/informative videos on managing of clinical conditions.The program will last 12 weeks with a frequency of two sessions a week, each lasting about 45 min.
干预措施: Educational Program (Device)
结局指标
主要结局
Adherence to treatment
时间窗: 12 weeks of treatment
Adherence to treatment, in terms of both numbers of drop-out and percentage of attended sessions on the total prescribed
次要结局
- Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Conti et al., 2015)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Change in visuoperceptual and attentional abilities measured by Symbol Digit Modalities Test (SDMT; Smith A., 1973; Nocentini U., 2006)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Change in executive functions, including visual attention and inhibitory control of behavior measured by Stroop Test (Caffarra et al., 2002)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Change in Verbal and semantic fluency measured by The Verbal Fluency and Semantic Tests (Carlesimo et al., 1996; Novelli et al., 1986).(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Change in long term visual memory measured by Free and Cued Selective Reminding Test (FCSRT) (Frasson et al., 2011)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Changes in affect measured by Positive-Negative Affect Schedule (PANAS; Watson et al, 1988)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Change in long term verbal memory measured by 15-Words of Rey (Carlesimo et al., 1995)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Change in Static and dynamic balance measured by Mini-Best Test (Franchignoni et al., 2010)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Change in Aerobic Capacity and Gait measured by 6' Minute Walking Test (6MWT)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Changes in patient's self-rated health measured by EuroQol five dimensions (5D) and five levels (5L) (The EuroQol Group, 1990; Janssen et al.,2013)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Changes in patient's self-rated health status measured by Short Form Health Survey 36 (SF36; Ware, 2000)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Changes in patient's fatigue measured by Modified Fatigue Index Scale (MFIS; Kos et al., 2006)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Changes in depressive symptoms measured by Beck Depression Inventory for Primary Care (BDI-PC, Steer et al., 1999)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
- Changes in anxiety level measured by State-Trait Anxiety Inventory - Form Y (STAI - Y; Spielberger, 1983; Pedrabissi & Santinello, 1989)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))