Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation
NCT ID: NCT06820125
Last Updated: 2025-02-11
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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RECRUITING
NA
48 participants
INTERVENTIONAL
2023-07-05
2026-07-05
Brief Summary
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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.
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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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Cognitive Group (CG)
60 minutes of cognitive training with a computerized device
Cognitive rehabilitation: CG group
60 minutes of cognitive training with a computerized device
Motor Group (MG)
60 minutes of robot-assisted gait training with the G-EO System
Motor rehabilitation: MG group
60 minutes of robot-assisted gait training with the G-EO System
Combined Group (CbG)
30 minutes of cognitive training with a computerized device + 30 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Universita di Verona
OTHER
Responsible Party
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Nicola Smania, MD, Clinical Professor
Doctor
Locations
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Sezione medicina fisica e riabilitativa dipartimento di neuroscienze
Verona, verona, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4257CESC
Identifier Type: -
Identifier Source: org_study_id
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