Telerehabilitation in Progressive Multiple Sclerosis
ConditionProgressive Multiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversita di Verona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Telerehabilitation (Euleria Home)
DeviceAfter 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.
Conventional therapy
Other interventionAfter 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.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Home-based Digital motor Telerehabilitation added to conventional therapyExperimental treatment 2 interventions
Group B: Conventional therapy aloneOther 1 intervention
Trial outcomes
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.
Time frame
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
1
Change in the Multiple Sclerosis Functional Composite (MSFC)
Multiple Sclerosis Functional Composite (MSFC) is a multidimensional, three-component performance scale to assess the degree of impairment in MS patients: gait, upper extremity function, and cognition. Since the units of three variables measured by three tests are different (Timed 25-foot Walk Test (T25FW) and 9-Hole Peg Test (9HPT) and number of correct answers in 3-second version of the Paced Auditory Serial Addition Test (PASAT-3)), raw scores should be converted to a common metric, namely z-scores. The overall composite score (MSFC score) is calculated by adding the z-scores for each test. Component scores are entered into a formula with scores from the reference population in order to derive the means and standard deviations required to determine Z-scores. A score of +1 indicates that, on average, an individual scored 1 SD better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.
Time frame
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)2
Mental workload through Electroencephalography (EEG) during Multiple Sclerosis Functional Composite Score
During the Multiple Sclerosis Functional Composite (MSFC) administration, the participant's brain activity will be recorded using electroencephalography (EEG) to assess the participant's mental workload and vigilance state during the task.
Time frame
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)3
Vigilance state through Electroencephalography (EEG) during Multiple Sclerosis Functional Composite Score
During the Multiple Sclerosis Functional Composite (MSFC) administration, the participant's brain activity will be recorded using electroencephalography (EEG) to assess the participant's vigilance state during the task.
Time frame
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)4
Surface electromyography (EMG) during the performance of the Nine Hole Peg test part of the Multiple Sclerosis Functional Composite (MSFC).
The muscular activity of the upper limb will be recorded using surface electromyography (EMG) system during the performance of the Nine Hole Peg test part of the Multiple Sclerosis Functional Composite (MSFC).
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universita di Verona
Lead sponsor
Università degli Studi di Ferrara
Collaborator
Source ClinicalTrials.gov
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