Cognitive-motor Telerehabilitation in MS

ConditionMultiple Sclerosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversitair Ziekenhuis Brussel

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically definite multiple sclerosis (revised McDonald criteria 2017)

Expanded Disability Status Scale (EDSS) below 6.0

Digit span backwards z-score between [-3 and -0.5] standard deviations below the median of the normative values

Age between 18 and 65

Disqualifiers

Cognitive rehabilitation within six months before inclusion

Inpatient multidisciplinary rehabilitation program within three months before inclusion or planned inpatient program during trial

Start of or switch in immunomodulator treatment within three months before inclusion

Less than one month post-exacerbation

Trial design

Design model

Parallel

Treatments tested in this trial

Cognitive training
Behavioral
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.
Motor training
Behavioral
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.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Cognitive-motor training groupExperimental treatment 2 interventions

Group B: Cognitive training groupActive comparator 1 intervention

Group C: Motor training groupActive comparator 1 intervention

Trial outcomes