MedTrace Logo

Telerehabilitation in Progressive Multiple Sclerosis

NCT06485115 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-07-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Digital Telerehabilitation (Euleria Home)

After the in-hospital rehabilitation treatment (1 h/day, 3 days/week), the EG patients will perform the Digital Telerehabilitation program at home. The three weekly sessions will be asynchronous (with the caregiver's supervision if necessary). At each Unit, the physiotherapist will develop the training sessions on the Home- based Digital Telerehabilitation program and monitor the training execution provided by the digital device to adapt the rehabilitation treatment to the patients' improvements/difficulties. The Digital Telerehabilitation device (Euleria Home, Euleria Health) will consist of one wearable sensor and an app on a tablet that guides the patient through the customized exercise-therapy path configured by the professional. The sensor is worn on different body segments to monitor movements and provides real-time feedback on angles, balance, and repetitions.

OTHER

Conventional therapy

After the in-hospital rehabilitation treatment (1 h/day, 3 days/week), the CG patients will be advised to perform the Self-management activities learned during the in-hospital rehabilitation training without home-based Digital Telerehabilitation devices.

Sponsors & Collaborators

  • Università degli Studi di Ferrara

    collaborator OTHER

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Marialuisa Gandolfi · Universita di Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485115 on ClinicalTrials.gov