NCT04169750

Home-based EXergames To impRove cognitivE Function in MUltiple Sclerosis

Home-based EXergames To impRove cognitivE Function in MUltiple Sclerosis: the EXTREMUS Study. A Multicenter, Randomized, Single-blind Non-inferiority Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: San Camillo Hospital, Rome · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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: 1. 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 2. 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 3. 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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	Exergames	The training protocol will be delivered by the Nintendo ® Wii balance board and consists of repetitions of several games selected from the "Wii Fit Plus" package (http:// www.wiifit.com/training/balance-games.html). Each game starts at basic level, and when a certain score is reached, patients is automatically transferred to a more advanced level. Patients will be encouraged to play the next game if they have a level progress; otherwise, 10 minutes will be allocated for each game. During the first 4 weeks of training, patients will be allowed to play only "Zazen" (sitting position), "Table Tilt" and "Ski Slalom"; thereafter they will add the remaining games "Penguin Slide", "Tightrope Walk", "Balance Bubble" and "Soccer Heading".
BEHAVIORAL	Adaptive COGNI-TRAcK	The training protocol will be delivered by a dedicated app for mobile devices (mobile phone or tablet). The app implements three different types of exercises (each one executed for about 10 min a session), consisting in a visuo-spatial working memory task, an "operation" N-back task and a "dual" N-back task. The adaptive training is structured so that the exercises difficulty level will increase by one step every time the user will perform a correct exercise. On the other hand, the difficulty level will decrease by one step if the exercise is incorrect for three times in a row.
BEHAVIORAL	Sham COGNI-TRAcK	The training protocol will be delivered by a dedicated app for mobile devices (mobile phone or tablet) as previously described for adaptive COGNI-TRAcK. However, the non-adaptive training (placebo-analogue intervention) consists in an algorithm implementing two low difficulty levels alternating every day regardless of the user's performance.

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-06-30
• Completion: 2022-09-30
• First posted: 2019-11-20
• Last updated: 2021-10-01

Locations

4 sites across 1 country: Italy