Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ente Ospedaliero Ospedali Galliera | OTHER |
| Fondazione Italiana Sclerosi Multipla | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal functional training | Experimental | Multimodal training to reduce fatigue and to improve balance and strength |
|
| Usual care | Active Comparator | Rehabilitative intervention to improve balance and mobility |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal functional training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| difference in walking velocity during the fatiguing walking test | difference between velocity at the beginning of the test and velocity at the end of the fatiguability walking test, [m/s] | Baseline and at 6-8 weeks (after the completion of 16 training sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| gait asymmetry and gait regularity | 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. | Baseline and at 6-8 weeks (after the completion of 16 training sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Fatigue Impact Scale (MFIS) | Assessment of fatigue with a 21-items questionnaire that ranges from 0 to 36 as maximum score. | Baseline and at 6-8 weeks (after the completion of 16 training sessions) |
| Multiple Sclerosis Walking Scale-12 (MSWS-12) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Gervasoni, Phd | Contact | 3334534540 | 0039 | egervasoni@dongnocchi.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Don Carlo Gnocchi | Recruiting | Milan | MI | 20148 | Italy |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual care | Other | Exercises aimed at improving balance and mobility |
|
| Antero-posterior and medio-lateral accelerations in stabilometric tasks |
Antero-posterior and medio-lateral accelerations from the IMU placed on the pelvis during a 60 seconds tasks performed with open and closed eyes. |
| Baseline and at 6-8 weeks (after the completion of 16 training sessions) |
| Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS) | 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. | Baseline and at 6-8 weeks (after the completion of 16 training sessions) |
Assessment of perceived walking ability with a 12-items questionnaire that ranges from a minimum of 12 points to a maximum of 60 points.
| Baseline and at 6-8 weeks (after the completion of 16 training sessions) |
| Activities Balance Confidence Scale (ABC) | Assessment of perceived balance with a 16-items questinnaire that ranges from a minimum of 0% to a maximum of 100%. | Baseline and at 6-8 weeks (after the completion of 16 training sessions) |
| Beck Depression Inventory (BDI-II). | Assessment of mood and anxiety with a 21-items questionnaire that ranges from a minimum of 0 points to a maximum of 63 points | Baseline and at 6-8 weeks (after the completion of 16 training sessions) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |