Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2023
CompletedFirst Submitted
Initial submission to the registry
January 24, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2026
ExpectedFebruary 11, 2025
December 1, 2024
Same day
January 24, 2025
February 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Symbol Digit Modalities Test
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).
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment
2-minute walking test
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).
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment
Secondary Outcomes (12)
Brief Repeatable Battery (BRB)
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Stroop Test (ST)
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Trail Making Test (TMT)
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Verbal Fluency Test (VF)
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Modified Five Point Test (MFPT)
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
- +7 more secondary outcomes
Study Arms (3)
Cognitive Group (CG)
EXPERIMENTAL60 minutes of cognitive training with a computerized device
Motor Group (MG)
EXPERIMENTAL60 minutes of robot-assisted gait training with the G-EO System
Combined Group (CbG)
EXPERIMENTAL30 minutes of cognitive training with a computerized device + 30 minutes of robot-assisted gait training with the G-EO System.
Interventions
60 minutes of cognitive training with a computerized device
60 minutes of robot-assisted gait training with the G-EO System
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sezione medicina fisica e riabilitativa dipartimento di neuroscienze
Verona, verona, 37134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
January 24, 2025
First Posted
February 11, 2025
Study Start
July 5, 2023
Primary Completion
July 5, 2023
Study Completion (Estimated)
July 5, 2026
Last Updated
February 11, 2025
Record last verified: 2024-12