RecruitingNot ApplicableNCT05355389

Cognitive-motor Telerehabilitation in MS

Cognitive-motor Telerehabilitation in Multiple Sclerosis

Sponsor

Universitair Ziekenhuis Brussel

Enrollment

90 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

Summary

The primary goal of this project is providing evidence that a home-based combined cognitive-motor training program improves cognition in persons with multiple sclerosis (MS), compared to single cognitive and motor rehabilitation. Secondary goals are to assess the effects on walking performance and to identify the mechanisms of improvement and predictors of treatment response. The main backbone of this project will be a randomized controlled two-centre clinical trial, in which an at-home computerised cognitive-motor rehabilitation program using telemedicine aimed at improving working memory in persons with MS will be evaluated. Based on the information gathered during this trial, possible mechanisms of improvement will be identified by analysing anatomical and neurophysiological changes on structural MRI and resting-state and task-related EEG before and after rehabilitation. Furthermore, factors that can predict treatment response to the rehabilitation program will be identified.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a telerehabilitation program delivered remotely (online) that combines cognitive and physical exercises for people with multiple sclerosis (MS) who have mild to moderate memory and thinking difficulties. The goal is to see if this program improves both brain function and movement. **You may be eligible if...** - You have a confirmed diagnosis of multiple sclerosis - You have mild to moderate memory/cognitive difficulties (measured by a digit span test) - Your disability level is below a moderate threshold (EDSS score below 6.0) - You are between 18 and 65 years old - You can safely do physical rehabilitation at home **You may NOT be eligible if...** - You have received cognitive rehabilitation in the past 6 months - You have been in an inpatient rehabilitation program recently or have one planned - You recently changed your MS disease-modifying medication - You had a relapse less than one month ago - You have a major psychiatric condition that would affect cognitive test results - You are unable or unwilling to undergo EEG or MRI testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive training

For the cognitive treatment intervention the widely used cognitive training program RehaCom will be used. This is a computer-aided program with more than 30 modules focusing on different domains of cognition. RehaCom has shown improvements in verbal learning, visuospatial memory, information processing speed, attention, executive functions, depression, fatigue and quality of life in PwMS (PMID 31927200, 28116167, 19825502, 23192417). Patients will train on their home computer without direct therapist supervision, using three RehaCom modules that are focused on improving working memory. Both patients in the combined intervention and the cognitive intervention group will be doing a 45-minute computer session respectively one and two days per week for a total of 12 weeks.

BEHAVIORALMotor training

For the motor treatment intervention a patient-tailored aerobic training program will be used. Based on their baseline physical activity level patients can choose out of a number of aerobic activities of either mild, moderate or strenuous intensity, with a total training time of 90 minutes for the motor intervention group and 45 minutes for the combined intervention group, divided over at least two training sessions per week of at least 15 minutes per session. The training will be carried out individually at home, without therapist supervision. All physical activities will be logged using the sport watch equipped with a heart rate sensor and an accelerometer. Training intensity will be assessed using the patient's heart rate and the Rating of Perceived Exertion scale.

Locations(2)

Universitair Ziekenhuis Brussel

Brussels, Belgium

National MS Center Melsbroek

Melsbroek, Belgium

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NCT05355389

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