Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation

NCT ID: NCT06820125

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2026-07-05

Brief Summary

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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.

Detailed Description

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Conditions

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Rehabilitation Multiple Sclerosis Cognitive Deficit Motor Deficits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cognitive Group (CG)

60 minutes of cognitive training with a computerized device

Group Type EXPERIMENTAL

Cognitive rehabilitation: CG group

Intervention Type DEVICE

60 minutes of cognitive training with a computerized device

Motor Group (MG)

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

Group Type EXPERIMENTAL

Motor rehabilitation: MG group

Intervention Type DEVICE

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

Combined Group (CbG)

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

Group Type EXPERIMENTAL

Combined rehabilitation: CbG group

Intervention Type DEVICE

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.

Interventions

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Cognitive rehabilitation: CG group

60 minutes of cognitive training with a computerized device

Intervention Type DEVICE

Motor rehabilitation: MG group

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

Intervention Type DEVICE

Combined 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Nicola Smania, MD, Clinical Professor

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sezione medicina fisica e riabilitativa dipartimento di neuroscienze

Verona, verona, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valentina Varalta

Role: CONTACT

045 8124956

Facility Contacts

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Nicola Smania, Direttore

Role: primary

045 8124573

Other Identifiers

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4257CESC

Identifier Type: -

Identifier Source: org_study_id

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