Home-based EXergames To impRove cognitivE Function in MUltiple Sclerosis: the EXTREMUS Study. A Multicenter, Randomized, Single-blind Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- Symbol Digit Modalities Test
研究概览
简要总结
Study design: Phase II, multicenter, randomized, sham-controlled, single-blind, parallel arm, multicenter study to test the hypothesis that home-based exergames is not inferior to home-based cognitive rehabilitation delivered by a software application (app) for mobile devices and both interventions are superior to a placebo-analogue cognitive intervention in improving cognitive function and reducing cognitive-motor interference in people with multiple sclerosis (MS).
Procedures: Participants will be randomized in a 1:1:1 ratio to receive an 8-week home-based training with exergames (intervention of interest) or adaptive COGNI-TRAcK (comparator intervention) or sham COGNI-TRAcK (placebo-analogue intervention). Study assessment will be done at study enrolment (baseline), at the end of the 8-week intervention period (immediate post-training, Week 8) and after 16 weeks from randomization (post-training follow-up, Week 16).
Investigational interventions:
- Exergames: home-based repetition of several games delivered by the Nintendo © Wii Balance Board, a commercial off-the-shelf video game console for re-training of balance and postural strategies
- Adaptive COGNI-TRAcK: adaptive (i.e. automatic adjustment of tasks difficulty) working memory training delivered by a customized application software for mobile devices to self-administer at-home
- Sham COGNI-TRAcK: non-adaptive (i.e. constant difficulty level) working memory training delivered by the same app as afore described
Primary endpoint: changes at the Symbol Digit Modalities Test (SDMT), a measure of sustained attention and information processing speed.
Secondary endpoint: changes at the BICAMS (z-scores), a brief, practical and universal assessment tool for cognitive impairment in MS.
Additional endpoints: magnitude of cognitive-motor interference estimated as dual-task cost of balance and walking.
Sample size estimation: The investigators estimated a pre-defined 8-point non-inferiority margin, based on a significant effect of the COGNI-TRAcK in inducing an about 8-point mean increase at SDMT score (with respect to a sham intervention). Accordingly, 35 participants per arm are required to ensure, with an approximately 85%-power level, that the lower limit of a one-side 95% confidence interval will be above the pre-defined non-inferiority margin. Therefore, considering also a drop-out rate of 25%, a total of 132 subjects should be enrolled.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 55 years (inclusive);
- •cognitive impairment, defined as failure in the SDMT, defined as a corrected score less than 38, i.e. below the 5th percentile of normative value;
- •Expanded Disability Status Scale (EDSS) score between 2.0 and 5.5;
- •ability to stand upright for at least 180 seconds without any support;
- •ability to understand and comply with study requirements;
- •ability to provide a valid informed consent before any study procedure.
排除标准
- •relapse in the previous 6 months;
- •initiation of disease-modifying or symptomatic treatments or physiotherapy programme in the 3 months prior to study entry;
- •any medication/physiotherapy changes occurring over the previous 3 months;
- •significant visual impairment, defined as a Visual System scoring more than 2 at the Kurtzke Functional Systems Score;
- •clinically relevant depression, defined as Beck Depression Inventory-II (BDI-II) score equal or more than 14;
- •overt dementia, defined as an adjusted Mini Mental State Examination (MMSE) score equal or less than 24;
- •history of epilepsy or seizures;
- •any medical condition, including musculoskeletal disorders that can interfere with the study conduction.
研究组 & 干预措施
Exergames
干预措施: Exergames (Behavioral)
Adaptive COGNI-TRAcK
干预措施: Adaptive COGNI-TRAcK (Behavioral)
Sham COGNI-TRAcK
干预措施: Sham COGNI-TRAcK (Behavioral)
结局指标
主要结局
Symbol Digit Modalities Test
时间窗: Change from randomization to 8-week visit
The participant is presented with a page headed by a key that pairs the single digits 1-9 with nine symbols. Rows below contain only symbols, the subject's task is to orally report the correct number in the spaces below. After completing the first 10 items with guidance, the subject is timed to determine how many responses can be made in 90 seconds. Range score: not applicable. Higher scores mean a better outcome. Explored domain: Sustained attention and information processing speed.
次要结局
- Stroop Color-Word Test(At randomization, 8 weeks and 16 weeks)
- Brief International Cognitive Assessment for Multiple Sclerosis(At randomization, 8 weeks and 16 weeks)
研究者
Luca Prosperini
Principal Investigator
San Camillo Hospital, Rome