Home-based EXergames To impRove cognitivE Function in MUltiple Sclerosis
NCT ID: NCT04169750
Last Updated: 2021-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
135 participants
INTERVENTIONAL
2020-03-01
2022-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exergames
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".
Adaptive COGNI-TRAcK
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.
Sham COGNI-TRAcK
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.
Interventions
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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".
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Fondazione Don Carlo Gnocchi Onlus
OTHER
Fondazione Italiana Sclerosi Multipla
OTHER
Rehabilitation Unit 'Mons. L. Novarese' Hospital, Moncrivello (VC), IT
UNKNOWN
University of Chieti
OTHER
San Camillo Hospital, Rome
OTHER
Responsible Party
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Luca Prosperini
Principal Investigator
Principal Investigators
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Luca Prosperini, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
A.O. San Camillo-Forlanini
Locations
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Italian MS Foundation
Genova, GE, Italy
LaRiCE Lab, Don Gnocchi Foundation IRCCS
Milan, MI, Italy
A.O. San Camillo, MS Center
Rome, RM, Italy
Dept. of Rehabilitation, M.L. Novarese
Moncrivello, VC, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Prosperini L, Tacchino A, Ruggieri S, Brichetto G, Podda J, Anastasi D, Cardini R, Corrini C, Quartuccio ME, Alcamisi I, Di Giovanni R, Gamberini G, Grange E, Pietrolongo E, Rispoli MG, Tomassini V, Cattaneo D, Solaro C. Home-based EXergames To impRovE cognitive function in MUltiple Sclerosis (EXTREMUS). J Neurol Neurosurg Psychiatry. 2025 Oct 1:jnnp-2025-336609. doi: 10.1136/jnnp-2025-336609. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2017/R/22
Identifier Type: -
Identifier Source: org_study_id
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