Cognitive rehabilitation: CG groupMotor rehabilitation: MG groupCombined rehabilitation: CbG group
Cognitive rehabilitation: CG group: 60 minutes of cognitive training with a computerized device
Motor rehabilitation: MG group: 60 minutes of robot-assisted gait training with the G-EO System
Combined rehabilitation: CbG group: 30 minutes of cognitive training with a computerized device + 30 minutes of robot-assisted gait training with the G-EO System. To mitigate the effects of fatigue in sequential training, the patients included in this group will undergo the cognitive (treatment CG) and motor (treatment MG) sessions in a counterbalanced order (half of the participants will follow the CG-MG sequence, and the other half will follow the MG-CG sequence). Five-minute breaks will be provided between the cognitive and motor sessions.
Study summary
The first aim of this project is to investigate the effects of different high-tech neurorehabilitation interventions (cognitive, motor, and combined cognitive-motor) on both cognitive and motor disability outcomes in people with multiple sclerosis (MS).
The second aim is to identify the cognitive and motor profiles of MS patients who benefit the most from either the combined cognitive-motor rehabilitation intervention or the isolated cognitive or motor treatments.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* presence of mild (one or two neuropsychological tests below the cut-off score, 5th percentile) or severe (more than two neuropsychological tests below the cut-off score, 5th percentile) cognitive impairment,
* mild to moderate walking disability with Expanded Disability Status Scale (EDSS) between 3 and 6,
* no relapse or associated steroid use in the past three months,
* adequate visual and auditory capacity to operate computer software.
Exclusion Criteria:
* presence of other neurological disorders than MS,
* major psychiatric disorders,
* high levels of anxiety and/or depression (score\>20 for Depression scale and up to 14 for Anxiety scale on Italian adaptation of the Depression, Anxiety and Stress Scale (DASS-21),
* substance abuse,
* any type of rehabilitation intervention in the month prior to recruitment
* pharmacological therapy not well defined and/or changed during the study
* presence of paroxysmal vertigo
* lower limb botulinum toxin injections within the previous 12 weeks
Primary outcome measure(s)
Symbol Digit Modalities Test — The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment This test evaluates the visual information processing speed and attention; the number of correct answers in 90 seconds is registered (higher scores indicate better performance).
2-minute walking test — The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment The 2MWT will be administered to measure self-paced walking ability. Patients will be asked to walk back and forth, as fast as they could, along a 30-m indoor corridor in 2 minutes. No talking will be permitted during the test. The distance walked (in meters) will be recorded (higher scores indicated better performance).
Trial sites (1)
Facility
City
Region
Status
Sezione medicina fisica e riabilitativa dipartimento di neuroscienze
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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