Multiple Sclerosis
Conditions
Keywords
fatigue, balance
Brief summary
Fatigability is one of the most prevalent disorder in MS followed by walking, balance and cognitive disorders. However, there are few experimental studies on the effects of fatigability on balance and gait hampering the knowledge of causal fatigue-related changes of walking, balance and cognition. Nowadays, instrumented systems such as wearable devices and optoelectronic systems are available and can be used to provide quantitative and objective indexes useful to monitor the changes of gait parameters during a fatiguing performance. (Moreover), instrumented assessment of patients' performances in dual task paradigms can reveal the possible impact of fatigability on cognitive functions. So far, high intensity functional training has been already used in MS to reduce fatigability. However, the true impact of reduced fatigability on walking, balance and cognition has not been assessed after a fatiguing task making impossible to understand the real impact of treatments focusing on fatigability on these functions. Thus, the aims of the present proposal are to assess the: 1) the acute effect of experimentally induced motor fatigability on walking, balance and cognitive functions using an objective instrumented assessment before, during, and after an overground fatiguing walking test. 2) to investigate the effect of high intensity multimodal functional training to improve motor and cognitive disorders.
Interventions
OTHERMultimodal functional training
40 minutes of multimodal functional training: 20 minutes of aerobic training on treadmill, 10 minutes of dynamic balance training; 10 minutes of functional strength training.
OTHERUsual care
Exercises aimed at improving balance and mobility
Sponsors
Fondazione Don Carlo Gnocchi ETS
Ente Ospedaliero Ospedali Galliera
Fondazione Italiana Sclerosi Multipla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* More than 18 years of age * Clinical diagnosis of Multiple Sclerosis (MS) * Stable disease course without worsening more than 1 EDSS point over the last 3 months, -EDSS between 1.5 and 6 points * Must be able to maintain upright posture without any assistance for 30 seconds * Must be able to release a written informed consent.
Exclusion criteria
* MS relapse within the previous three months; * Unable to comprehend the aims of the study and to follow test instructions; * Diagnosis of major depression (DSM-5); * Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment); * Cardiovascular diseases; * Unconfirmed or uncertain diagnosis of MS (McDonald criteria) * Other concomitant neurological disease; * Patients already performing aerobic or walking exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| difference in walking velocity during the fatiguing walking test | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | difference between velocity at the beginning of the test and velocity at the end of the fatiguability walking test, \[m/s\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gait asymmetry and gait regularity | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | gait asymmetry, gait regularity on the vertical and medio-lateral plane estimated by autocorrelation coefficients during the fatiguability walking test. These variables will be calculated from IMU's data. |
| Antero-posterior and medio-lateral accelerations in stabilometric tasks | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | Antero-posterior and medio-lateral accelerations from the IMU placed on the pelvis during a 60 seconds tasks performed with open and closed eyes. |
| Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS) | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | BICAMS includes the Symbol Digit Modalities test (SDMT), the California Verbal Learning Test-2 (CVLT2) and the Brief Visuospatial Memory Test-Revised (BVMT-R). The total scores will be calculated considering the normative scores. The score on the oral SDMT varies from 0 to 110 and must be calculated with respect to years of schooling. The CVLT2 score varies from a minimum of 0 to a maximum of 16 points. The BVMT-R score ranges from a minimum of 0 to a maximum of 36 points. |
Countries
Italy
Outcome results
None listed