Telerehabilitation in Progressive Multiple Sclerosis

NCT06485115 | Not Yet Recruiting DMC

• 1 other identifier: 2023/R-Multi/010
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Progressive Multiple Sclerosis

Keywords

Balance; Dual Task; Cognitive Function; Digital Telemedicine; Wearables

Outcome Measures

Primary Outcomes (1)

• Change in the Timed Up and Go test

  The patient mobility will be measured by the Timed Up and Go (TUG) test (Euleria Lab, Rovereto - TN, Italy). We will give patients verbal instructions to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down.

  Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks after the in-hospital treatment (T3)

Secondary Outcomes (44)

• Change in the Multiple Sclerosis Functional Composite (MSFC)

  Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks after the in-hospital treatment (T3)

• Mental workload through Electroencephalography (EEG) during Multiple Sclerosis Functional Composite Score

  Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks after the in-hospital treatment (T3)

• Vigilance state through Electroencephalography (EEG) during Multiple Sclerosis Functional Composite Score

  Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks after the in-hospital treatment (T3)

• Surface electromyography (EMG) during the performance of the Nine Hole Peg test part of the Multiple Sclerosis Functional Composite (MSFC).

  Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks after the in-hospital treatment (T3)

• Inertial Measurement Unit (IMU) system during the performance of the Nine Hole Peg test part of the Multiple Sclerosis Functional Composite (MSFC).

  Before treatment (T0), after 4 weeks of in-hospital rehabilitation (T1), at the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2), and 24 weeks after the in-hospital treatment (T3)

Study Arms (2)

Home-based Digital motor Telerehabilitation added to conventional therapy

EXPERIMENTAL

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).

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

Conventional therapy alone

OTHER

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.

Other: Conventional therapy

Interventions

Digital Telerehabilitation (Euleria Home) DEVICE

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.

Home-based Digital motor Telerehabilitation added to conventional therapy

Conventional therapy OTHER

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.

Conventional therapy alone; Home-based Digital motor Telerehabilitation added to conventional therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universita di Verona: lead
• Università degli Studi di Ferrara: collaborator

Study Sites (1)

Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona

Verona, 37131, Italy

Location

Related Publications (49)

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MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marialuisa Gandolfi

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marialuisa Gandolfi, PhD

CONTACT

+390458124943; marialuisa.gandolfi@univr.it

Marialuisa Gandolfi

CONTACT

3491656108; marialuisa.gandolfi@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 3, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)