Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation

University of Verona

Status: Enrolling

Conditions: Rehabilitation; Multiple Sclerosis; Motor Deficits; Cognitive Deficit

Treatments: Device: Cognitive rehabilitation: CG group; Device: Combined rehabilitation: CbG group; Device: Motor rehabilitation: MG group

Study type: Interventional

Funder types: Other

Identifiers

NCT06820125

4257CESC

Details and patient eligibility

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Cognitive Group (CG)

Experimental group

Description:

60 minutes of cognitive training with a computerized device

Treatment:

Device: Cognitive rehabilitation: CG group

Motor Group (MG)

Experimental group

Description:

60 minutes of robot-assisted gait training with the G-EO System

Treatment:

Device: Motor rehabilitation: MG group

Combined Group (CbG)

Experimental group

Description:

30 minutes of cognitive training with a computerized device + 30 minutes of robot-assisted gait training with the G-EO System.

Treatment:

Device: Combined rehabilitation: CbG group