home-based exergames to improve cognitive function in multiple sclerosis

Conditions: Multiple Sclerosis

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.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.

Keywords: rehabilitation cognitive impairment exergames neuroplasticity clinical trial