RecruitingNot ApplicableNCT06820125

Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation

Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation in Patients with Multiple Sclerosis


Sponsor

Universita di Verona

Enrollment

48 participants

Start Date

Jul 5, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

Interventions

DEVICECognitive rehabilitation: CG group

60 minutes of cognitive training with a computerized device

DEVICEMotor rehabilitation: MG group

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

DEVICECombined rehabilitation: CbG group

30 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.


Locations(1)

Sezione medicina fisica e riabilitativa dipartimento di neuroscienze

Verona, verona, Italy

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NCT06820125


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