Telerehabilitation in Progressive Multiple Sclerosis

University of Verona

Status: Not yet enrolling

Conditions: Progressive Multiple Sclerosis

Treatments: Other: Conventional therapy; Device: Digital Telerehabilitation (Euleria Home)

Study type: Interventional

Funder types: Other

Identifiers

NCT06485115

2023/R-Multi/010

Details and patient eligibility

About

Multiple sclerosis (MS) is a highly disabling chronic, inflammatory, demyelinating disease of the Central Nervous System (CNS). Significant progress has been made during the past three decades in managing the relapsing-remitting phase of Multiple Sclerosis (RRMS). However, once patients have entered the progressive stage of MS (secondary progressive, SPMS), therapeutic options are limited to symptomatic treatments and rehabilitation. In addition, 10-20% of patients experience unremitting disease progression (primary progressive MS, or PPMS). The limited research focusing on Progressive MS (PMS) and the lack of ecological validity highlight the need for a bolder approach that combines more than one intervention intending to produce synergistic effects. The primary aim is to test the effectiveness of combining a home-based Digital Telerehabilitation program with in-hospital rehabilitation on mobility against in-hospital rehabilitation alone.

Full description

The literature emphasizes a striking dearth of studies devoted solely to people with SPMS or PPMS and the lack of ecological validity in assessing the results. This suggests that an additional effort is required, a bolder approach that combines more than one intervention intending to produce synergistic effects, an improvement in one area boosting the putative benefits of therapy in another, the overall outcome exceeding the sum of the individual treatments.

The primary aim will be to test the effectiveness of combining a home-based digital motor telerehabilitation program (experimental intervention) with in-hospital rehabilitation on mobility (primary outcome) against in-hospital rehabilitation without any additional therapy except for general instructions for self-management as usual care (conventional treatment) in patients with SPMS or PPMS.

The secondary aims will be to explore the effects on measures of motor and cognitive function; the patients reported outcomes on balance and upper extremity function, fatigue, pain, anxiety, and depressive symptoms; the self-perception of clinical change; and Health-Related Quality of Life. Furthermore, the investigators will explore the patient's perspective and experience with Digital Telerehabilitation post-treatment using quantitative-qualitative methods (EG intervention). An economic evaluation of the introduction of the digital telemedicine program will be carried out within the health technology assessment (HTA) framework, considering the perspective of the healthcare system and society as a whole.

This single-blind RCT with 2-parallel arms will compare the effects between the experimental group (EG) and control group (CG). After the screening, an administrator external to research groups (the principal investigator) will generate a block randomization list at each Unit to prevent selection bias using an automated randomization system (www.randomization.com) (allocation ratio 1:1) to assign eligible patients to either the EG or the CG. Patients will be stratified according to the EDSS (≥ 6 and < 6). Group allocation will be kept concealed. All patients will receive an individualized ten sessions of an in-hospital rehabilitation program (1 hour/day, 3 days/week) by a qualified physiotherapist at each participating unit. Then, the EG will follow a 12-week individualized Digital Telerehabilitation program (1 hour/day, 3 days/week, EG) while the CG will not receive any additional therapy except for general instructions for self-management according to the allocation group. All the patients will undergo four clinical evaluations: before (T0) and after (T1) the in-hospital rehabilitation program, 12 weeks (T2), and 24 weeks (follow-up, T3) after it. One researcher assistant with experience in assessing primary and secondary outcomes blinded to group assignment will evaluate study participants at all time points in each Unit.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75;
• Diagnosis of MS (primary or secondary progressive);
• Mild to moderate balance impairments with increased fall risk, defined as TUG > 8.4s;
• A disability rate, as calculated using the Kurtzke Expanded Disability Status Scale (EDSS) lower than 7;
• Acceptable level of digital skills;
• The presence of the caregiver.

Exclusion criteria

• Other conditions that may affect motor function;
• Impaired cognitive functioning (Mini-Mental Status Examination <24/30);
• Severe visual deficits (daltonism and visual acuity deficit);
• Unable or refused to attend the rehabilitation treatment.

Patients who fulfill the following specified inclusion criteria will also undergo an EEG evaluation. However, ineligibility for this examination does not exclude them from participating in the rehabilitation study.

The inclusion criteria for the EEG protocol will include:

• The absence of metallic implants in the brain;
• No history of brain surgery;
• No use of medications that alter cortical excitability or are presumed to affect brain plasticity;
• Right-handed dominance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Home-based Digital motor Telerehabilitation added to conventional therapy

Experimental group

Description:

All patients will receive an individualized ten sessions of an in-hospital rehabilitation program (1 hour/day, 3 days/week) by a qualified physiotherapist at each participating unit. Then, the EG will follow a 12-week individualized Digital Telerehabilitation program (1 hour/day, 3 days/week, EG).

Treatment:

Device: Digital Telerehabilitation (Euleria Home)

Other: Conventional therapy

Conventional therapy alone

Other group

Description:

All patients will receive an individualized ten sessions of an in-hospital rehabilitation program (1 hour/day, 3 days/week) by a qualified physiotherapist at each participating unit. Then, the CG will not receive any additional therapy except for general instructions for self- management according to the allocation group.

Treatment:

Other: Conventional therapy