Actively Recruiting
Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation in Patients with Multiple Sclerosis
Led by Universita di Verona · Updated on 2025-02-11
48
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different high-tech neurorehabilitation methods on cognitive and motor disabilities in people with multiple sclerosis (MS). The study aims to understand which patients benefit most from combined cognitive-motor rehabilitation compared to isolated cognitive or motor treatments. Participants are assigned to one of three groups: cognitive training using a computerized device for 60 minutes, robot-assisted gait training with the G-EO System for 60 minutes, or a combined group receiving 30 minutes of each type of training with breaks between sessions. The combined group will have sessions in varying sequences to reduce fatigue. Participants will undergo various cognitive and motor tests before treatment, after eight weeks of treatment, and two months post-treatment. These include the Symbol Digit Modalities Test, 2-minute walking test, and several other assessments measuring cognitive function, motor ability, fatigue, and quality of life. Satisfaction with treatment is also evaluated at the end. The study involves randomized assignment and single masking.
CONDITIONS
Brief Title
Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of mild or severe cognitive impairment based on neuropsychological tests below the 5th percentile cut-off
- Mild to moderate walking disability with Expanded Disability Status Scale (EDSS) between 3 and 6
- No relapse or steroid use in the past three months
- Adequate visual and auditory ability to use computer software
You will not qualify if you...
- Presence of neurological disorders other than multiple sclerosis
- Major psychiatric disorders
- High levels of anxiety or depression based on DASS-21 scores
- Substance abuse
- Any rehabilitation intervention within one month prior to recruitment
- Unstable or changed pharmacological therapy during the study
- Presence of paroxysmal vertigo
- Lower limb botulinum toxin injections within the previous 12 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either cognitive training with a computerized device, robot-assisted gait training with the G-EO System, or a combination of both. Sessions last 60 minutes for single interventions or 30 minutes each with breaks for combined training.
Weekly visits for up to 8 weeks
Duration - 2 months
Participants are assessed two months after the end of treatment to evaluate sustained effects of rehabilitation.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Sezione medicina fisica e riabilitativa dipartimento di neuroscienze
Verona, verona, Italy, 37134
Actively Recruiting
Research Team
V
Valentina Varalta
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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