Clinical trial NCT06820125: Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation
Official title: Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation in Patients with Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation
Multiple Sclerosis
Cognitive Deficit
Motor Deficits
Keywords: rehabilitation
multiple sclerosis
cognitive deficits
motor deficits
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Symbol Digit Modalities Test
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment
measure: 2-minute walking test
timeFrame: 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:
measure: Brief Repeatable Battery (BRB)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: The Stroop Test (ST)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Trail Making Test (TMT)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: The Verbal Fluency Test (VF)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: The Modified Five Point Test (MFPT)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Test of Attentional Performance (TAP; version 2.3.1)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: N-Back task
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Time up and Go (TUG)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: eight-infrared camera system (sampling frequency: 60-120 fps) with the VICON Vero 2.2 motion analysis system (Vicon Motion Analysis System Ltd),
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: The Multiple Sclerosis Quality of Life-29 (MSQOL-29)
timeFrame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: At the end of the treatment
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Sezione medicina fisica e riabilitativa dipartimento di neuroscienze
Study officials:
References: