Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversita di Verona
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive rehabilitation: CG group
Device60 minutes of cognitive training with a computerized device
Motor rehabilitation: MG group
Device60 minutes of robot-assisted gait training with the G-EO System
Combined rehabilitation: CbG group
Device30 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.
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: Cognitive Group (CG)Experimental treatment 1 intervention
Group B: Motor Group (MG)Experimental treatment 1 intervention
Group C: Combined Group (CbG)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment2
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).
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmentSecondary outcomes
1
Brief Repeatable Battery (BRB)
The the Brief Repeatable Battery (BRB) is composed of the Selective Reminding Test - SRT (to evaluate verbal learning and delayed memory recall; the words recalled in three different subtests are recorded); the Spatial Recall Test - SPART (to evaluate visuospatial learning and delayed memory recall; the total number of correct responses for the three trials and the delayed recall trial are recorded); the SDMT (described above); the Paced Auditory Serial Addition Test - PASAT (to assesses auditory information processing speed, attention, and calculation; the score is the sum of correct answers recorded - max 60); the Word List Generation -WLG (to assesses semantic verbal fluency; the score is the number of correct words recorded).
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen2
The Stroop Test (ST)
The Stroop Test (ST), which evaluates attention and the ability to inhibit automatic responses. The Stroop effect is evaluated by computing a time interference effect (based on execution time) and an error interference effect (based on number of errors).
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen3
Trail Making Test (TMT)
The Trail Making Test (TMT), which consists of two parts: the TMT-A, used as a measure of psychomotor speed and visual search/attention skills, and the TMT-B, used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded.
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen4
The Verbal Fluency Test (VF)
The Verbal Fluency Test (VF), which is composed of 3 subtests: the Phonemic Fluency, the Semantic Fluency, and the Phonemic/Semantic Alternate Fluency test. For each trial, the number of correct words generated in 60 sec is recorded. Performance score in each subtest is the sum of the correct words generated in all trials.
Time frame
The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmenSponsors and contacts
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Source ClinicalTrials.gov