Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation
Recruiting · NCT06820125 · Interventional (participants receive a specific treatment) · Lead sponsor: Universita di Verona
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive rehabilitation: CG groupCombined rehabilitation: CbG groupMotor rehabilitation: MG group
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Sezione medicina fisica e riabilitativa dipartimento di neuroscienze - Verona, verona, Italy