Progressive Multiple SclerosisNCT06485115
Telerehabilitation in Progressive Multiple Sclerosis
A study testing Digital Telerehabilitation (Euleria Home) and Conventional therapy in people with Progressive Multiple Sclerosis, run by Universita di Verona at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Progressive Multiple Sclerosis
- What is being tested?
- Digital Telerehabilitation (Euleria Home) and Conventional therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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 locations and contacts
1 site in 1 country.
Italy1 site
Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona
Verona, 37131
About this study
Official title: The Effectiveness of Combining a Home-based Digital Motor Telerehabilitation Program With Conventional Therapy in Progressive Multiple Sclerosis: a Multicentre, Randomized Controlled 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.
Read the detailed 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.
- Conditions
- Progressive Multiple Sclerosis
- Being tested
- Digital Telerehabilitation (Euleria Home), Conventional therapy
- Keywords
- Balance, Dual Task, Cognitive Function, Digital Telemedicine, Wearables
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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).
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).
Measured: 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).
The kinematics of the upper limb will be recorded using Inertial Measurement Unit (IMU) system during the performance of the Nine Hole Peg test part of the Multiple Sclerosis Functional Composite (MSFC).
Measured: 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)
Change in the Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations. The items are scored on a 7 point scale (1= strongly disagree and 7= strongly agree). The minimum score is 9 and maximum score possible is 63. Higher score indicate greater fatigue severity.
Measured: 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)
Change in the Activities-specific balance confidence (ABC)
The Activities-specific balance confidence (ABC) Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. It is a 16-item self-report measure in which patients rate their balance confidence for performing activities. Items are rated on a rating scale that ranges from 0 - 100. Score of zero represents no confidence, a score of 100 represents complete confidence. Overall score is calculated by adding item scores and then dividing by the total number of items.
Measured: 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)
Change in the Manual Ability Measure-36 (MAM-36)
The Manual Ability Measure-36 (MAM-36) is designed as an outcome instrument to assess hand function based on the patient's responses to functional questions. Patient rates functional abilities based on his or her perception of the difficulty or ease in completing one or two-handed daily tasks. Item level scores are as follows: 1=cannot do, 2=very hard, 3=a little hard and 4=easy, 0=not applicable/almost never do. The total score ranging from 0 to 144; higher scores indicate better-perceived manual ability.
Measured: 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)
The number of falls in the previous month
Number of falls in the previous month
Measured: 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)
Timed Up and Go (TUG) test - Cognitive
In the Timed Up and Go (TUG) test - Cognitive, individuals will be asked to complete the test while counting backward by threes from a randomly selected number between 20 and 100
Measured: 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)
Electroencephalography (EEG) during the Timed Up and Go (TUG) test - Cognitive
During the Timed Up and Go (TUG) test - Cognitive, the participant's brain activity will be recorded using electroencephalography (EEG) to assess the participant's mental workload and vigilance state during the task
Measured: 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)
Timed Up and Go (TUG) test - Manual
In the Timed Up and Go (TUG) test - Manual, individuals will be asked to complete the test holding a cup filled with water.
Measured: 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)
Electroencephalography (EEG) during the Timed Up and Go (TUG) test - Manual
During the Timed Up and Go (TUG) test - Manual, the participant's brain activity will be recorded using electroencephalography (EEG) to assess the participant's mental workload and vigilance state during the task
Measured: 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)
Change in the gait speed (cm/s)
Gait analysis will be used to collect gait speed (cm/s)
Measured: 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)
Change in the cadence (step/min)
Gait analysis will be used to collect cadence (step/min)
Measured: 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)
Change in the stride length (cm)
Gait analysis will be used to collect stride length (cm)
Measured: 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)
Change in the length of the centre of pressure (CoP)
Stabilometric platform will be used to evaluated the length of the centre of pressure (CoP)
Measured: 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)
Change in the trajectory (mm)
Stabilometric platform will be used to evaluated the trajectory (mm)
Measured: 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)
Change in the sway area (mm2)
Stabilometric platform will be used to evaluated the sway area (mm2)
Measured: 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)
Change in the Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) is a self-administered questionnaire divided into intensity (range: 0-40; higher = worse) and interference (range: 0-70; higher = worse)
Measured: 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)
Change in the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a brief self-report questionnaire composed of 14 items (7 items each for anxiety and depression), with a score ranging between 0 and 21 for the anxiety and depression subscales. Scores between 8 and 10 indicate a moderate presence of symptoms, whereas a score greater than 11 indicates a significant number of symptoms that likely correspond with a clinical diagnosis.
Measured: 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)
Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
The Hospital Anxiety and Depression Scale - Anxiety (HADS-A, 7 items) subscale scores will be calculated, possibly ranging from 0 (no symptoms) to 21 (most severe symptoms)
Measured: 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)
Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D)
The Hospital Anxiety and Depression Scale - Depression (HADS-D, 7 items) subscale scores will be calculated, possibly ranging from 0 (no symptoms) to 21 (most severe symptoms)
Measured: 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)
Change in the Modified Asworth Scale
The Modified Ashworth Scale is a 6-points muscle tone assessment scale used to assess the resistance experienced during passive range of motion. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
Measured: 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)
Change in the Modified Tardieu Scale
The Modified Tardieu Scale si a clinical measure of muscle spasticity in patients with neurological conditions. The Modified Tardieu Scale comprises four elements, including R1, R2, R2-R1 and X score. R1 represents an angle of catch, where a sudden increase of muscle resistance is felt during a fast passive stretch. R2 is an angle indicating the tested muscle length at a slow passive range of motion. R2-R1 was introduced to differentiate spasticity from contracture.15 Contracture is indicated if the value of R2-R1 is small, while a large value indicates spasticity. The X score describes types of muscle resistance when passive stretches are applied during the assessment (grade 0-5). Quality of Muscle Reaction (scored 0-5); 0 is no resistance to passive ROM to 5 indicating joint is immobile.
Measured: 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)
Change in the the Multiple Sclerosis Quality Of Life-54 (MSQOL-54)
The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. The single item measures are satisfaction with sexual function and change in health. There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores.
Measured: 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)
The EuroQol five domains (EQ-5D)
The EuroQol five-dimensions (EQ5D) is a versatile quality of life (QOL) instrument with five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a visual analog scale. It can be used to calculate quality-adjusted life years. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').
Measured: 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)
The volumes of health services
The volumes of health services will be collected at baseline encompassing the resources use 6 months prior the start of the study and 24 weeks after the in-hospital treatment (T3) estimating the resource use during the entire trial duration
Measured: Before treatment (T0), and 24 weeks after the in-hospital treatment (T3)
The Multiple Sclerosis Health Resource Utilization Survey (MS-HRS)
Direct healthcare costs will be assessed using the Multiple Sclerosis Health Resource Utilization Survey (MS-HRS). The Multiple Sclerosis Health Resource Utilization Survey (MS-HRS) is a multilingual, reliable, valid and easy to administer questionnaire providing a holistic cross-sectional and longitudinal assessment of resource utilization in people with multiple sclerosis.
Measured: Before treatment (T0), and 24 weeks after the in-hospital treatment (T3)
The TheiTA Productivity Cost Questionnaire
Indirect costs will be measured using validated log as the TheiTA Productivity Cost Questionnaire for productivity loss
Measured: Before treatment (T0), and 24 weeks after the in-hospital treatment (T3)
Change in the Clinical Global Impression (CGI)
Self-rated perception of change will be assessed with the 7-point Clinical Global Impression (CGI) scale with scores from 1 (very much improved) to 7 (very much worse)
Measured: 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)
Changes in effective brain connectivity through Electroencephalography (EEG)
Only patients eligible for EEG will be evaluated to detect changes in effective brain connectivity through EEG during a motor observation, execution, and motor imagery task.
Measured: 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)
Change in the Brief Illness Perception Questionnaire (B-IPQ)
The Brief Illness Perception Questionnaire (B-IPQ) consists of eight items on an individual's cognitive and emotional representation of one's health conditions.To score the B-IPQ questionnaire, each item is rated on a 0-10 scale, with higher scores indicating a more threatening perception of the illness. The total score is calculated by summing the scores of all eight items, with a possible range of 0-80. Higher scores indicate worse illness perception.
Measured: 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)
Change in the Multidimensional Psychological Flexibility Inventory (MPFI)
The Multidimensional Psychological Flexibility Inventory (MPFI), a 60-item scale that measures the 6 dimensions of psychological flexibility and the 6 dimensions of inflexibility posited by the Hexaflex model. To score the Multidimensional Psychological Flexibility Inventory subscales, are assigned responses point values from 1 to 6 and then average the responses across the items of each scale so that higher scores reflect higher levels of the dimension being assessed by each set of items. The averages of the 6 flexibility subscales can be averaged to create a composite representing global flexibility. Similarly, the averages of the 6 inflexibility subscales can be averaged to create a global inflexibility composite.
Measured: 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)
Change in the Self-Efficacy for Multiple Sclerosis Scale (SEMS)
The Self-Efficacy for Multiple Sclerosis Scale (SEMS) assesses self-efficacy related to the management of MS. It comprises 15 items starting from the root statement "I am confident that I can…" and is rated on a 5-point Likert scale from 0 (Not at all confident) to 4 (Very confident)
Measured: 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)
Tele-healthcare Satisfaction Questionnaire-Wearable Technology
Tele-healthcare Satisfaction Questionnaire-Wearable Technology consists of 6 areas (benefit, usability, self-concept, privacy and loss of control, quality of life, and wearing comfort) that evaluate the satisfaction of the subject with the wearable part of a system. Each area includes 5 statements rated by the user on a 5-point Likert scale between 0 (strongly disagree with the statement) and 4 (strongly agree with the statement)
Measured: At the end of the 12 weeks of telerehabilitation
Patients' In-home Digital Telerehabilitation training experience questionnaire
One questionnaire used by the research group to evaluate patients' In-home Digital Telerehabilitation training experience with the Digital Telerehabilitation program "EG treatment experience". The questionnaire consists of 9 questions scored on a 10-point scale (1=not at all; 10=very much) and 17 open-ended questions to investigate pleasantness, usefulness, acceptability, safety, satisfaction, and future development.
Measured: At the end of the 12 weeks of telerehabilitation
Activity levels through Technology-based Objective Measures (TOMS)
Wearable sensors (Axivity AX3) will be used to collect the activity levels.
Measured: 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)
Number of steps through Technology-based Objective Measures (TOMS)
Wearable sensors (Axivity AX3) will be used to collect the number of steps.
Measured: 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)
Distance traveled through Technology-based Objective Measures (TOMS)
Wearable sensors (Axivity AX3) will be used to collect the distance traveled.
Measured: 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)
Risk of fall assessment
An inertial sensor will be used to detect near falls during balance training and i twill be placed on the forehead with an elastic band.
Measured: During the 4 weeks in-hospital rehabilitation (3 days/week for 4 week - total of 10 sessions)
Adverse Events
Safety in terms of reported adverse events during the treatment (falls or event near falling) will be collected
Measured: At the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2)
Number of patients who accept/refuse the treatment
Measures of feasibility in terms of the recruitment rate before the end of treatment will be collected.
Measured: At the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2)
Number of dropouts
Measures of feasibility in terms of the number of dropouts before the end of treatment will be collected
Measured: At the end of the 12 weeks of telerehabilitation or usual care after the end of the in-hospital treatment (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Responsible party
- Principal investigator, Marialuisa Gandolfi, Universita di Verona
- Investigators
- Marialuisa Gandolfi, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485115
- Sponsor's protocol ID
- 2023/R-Multi/010
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lassmann H, Bruck W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol. 2007 Apr;17(2):210-8. doi: 10.1111/j.1750-3639.2007.00064.x.
PubMed 17388952Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology. 1996 Apr;46(4):907-11. doi: 10.1212/wnl.46.4.907.
PubMed 8780061Lassmann H, van Horssen J, Mahad D. Progressive multiple sclerosis: pathology and pathogenesis. Nat Rev Neurol. 2012 Nov 5;8(11):647-56. doi: 10.1038/nrneurol.2012.168. Epub 2012 Sep 25.
PubMed 23007702Feinstein A, Freeman J, Lo AC. Treatment of progressive multiple sclerosis: what works, what does not, and what is needed. Lancet Neurol. 2015 Feb;14(2):194-207. doi: 10.1016/S1474-4422(14)70231-5.
PubMed 25772898Morgen K, Kadom N, Sawaki L, Tessitore A, Ohayon J, McFarland H, Frank J, Martin R, Cohen LG. Training-dependent plasticity in patients with multiple sclerosis. Brain. 2004 Nov;127(Pt 11):2506-17. doi: 10.1093/brain/awh266. Epub 2004 Sep 29.
PubMed 15456705Tomassini V, Matthews PM, Thompson AJ, Fuglo D, Geurts JJ, Johansen-Berg H, Jones DK, Rocca MA, Wise RG, Barkhof F, Palace J. Neuroplasticity and functional recovery in multiple sclerosis. Nat Rev Neurol. 2012 Nov 5;8(11):635-46. doi: 10.1038/nrneurol.2012.179.
PubMed 22986429Tieri G, Morone G, Paolucci S, Iosa M. Virtual reality in cognitive and motor rehabilitation: facts, fiction and fallacies. Expert Rev Med Devices. 2018 Feb;15(2):107-117. doi: 10.1080/17434440.2018.1425613. Epub 2018 Jan 10.
PubMed 29313388Peran P, Nemmi F, Dutilleul C, Finamore L, Falletta Caravasso C, Troisi E, Iosa M, Sabatini U, Grazia Grasso M. Neuroplasticity and brain reorganization associated with positive outcomes of multidisciplinary rehabilitation in progressive multiple sclerosis: A fMRI study. Mult Scler Relat Disord. 2020 Jul;42:102127. doi: 10.1016/j.msard.2020.102127. Epub 2020 May 6.
PubMed 32438326Lotze M, Ladda AM, Stephan KM. Cerebral plasticity as the basis for upper limb recovery following brain damage. Neurosci Biobehav Rev. 2019 Apr;99:49-58. doi: 10.1016/j.neubiorev.2019.01.027. Epub 2019 Jan 30.
PubMed 30710580Schmidt R, Lee T, Winstein C, et al. Motor control and learning: a behavioral emphasis. 2018. cited Sep. 17, 2022.,36
Gandolfi M, Mazzoleni S, Morone G, Iosa M, Galletti F, Smania N. The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review. Expert Rev Med Devices. 2023 Jan;20(1):35-44. doi: 10.1080/17434440.2023.2169129. Epub 2023 Jan 29.
PubMed 36649574Dehem S, Montedoro V, Edwards MG, Detrembleur C, Stoquart G, Renders A, Heins S, Bruno D, Lejeune T. Development of a robotic upper limb assessment to configure a serious game. NeuroRehabilitation. 2019;44(2):263-274. doi: 10.3233/NRE-182525.
PubMed 31006692Maier M, Rubio Ballester B, Duff A, Duarte Oller E, Verschure PFMJ. Effect of Specific Over Nonspecific VR-Based Rehabilitation on Poststroke Motor Recovery: A Systematic Meta-analysis. Neurorehabil Neural Repair. 2019 Feb;33(2):112-129. doi: 10.1177/1545968318820169. Epub 2019 Jan 30.
PubMed 30700224Shaw MT, Best P, Frontario A, Charvet LE. Telerehabilitation benefits patients with multiple sclerosis in an urban setting. J Telemed Telecare. 2021 Jan;27(1):39-45. doi: 10.1177/1357633X19861830. Epub 2019 Jul 15.
PubMed 31307269Thompson AJ. Neurorehabilitation in multiple sclerosis: foundations, facts and fiction. Curr Opin Neurol. 2005 Jun;18(3):267-71. doi: 10.1097/01.wco.0000169743.37159.a0.
PubMed 15891410
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Combining a Home-based Digital Motor Telerehabilitation Program With Conventional Therapy in Progressive Multiple Sclerosis: a Multicentre, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06485115
- Acronym / sponsor ID
- 2023/R-Multi/010
- Conditions
- Progressive Multiple Sclerosis
- Keywords
- Balance, Dual Task, Cognitive Function, Digital Telemedicine, Wearables
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Digital motor Telerehabilitation added to conventional therapy | Experimental | Device: Digital Telerehabilitation (Euleria Home), Other: Conventional therapyAll 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). |
| Conventional therapy alone | Other | Other: Conventional therapyAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Home-based Digital motor Telerehabilitation added to conventional therapy |
| Conventional therapyAfter 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. | Other | Conventional therapy alone, Home-based Digital motor Telerehabilitation added to conventional therapy |
Primary outcome
Change in the Timed Up and Go test
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)
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.
44 secondary outcomes
Change in 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)
Mental workload through Electroencephalography (EEG) during Multiple Sclerosis Functional Composite Score
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)
Vigilance state through Electroencephalography (EEG) during Multiple Sclerosis Functional Composite Score
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)
Surface electromyography (EMG) 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)
Inertial Measurement Unit (IMU) 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)
Change in the Fatigue Severity Scale (FSS)
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)
Change in the Activities-specific balance confidence (ABC)
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)
Change in the Manual Ability Measure-36 (MAM-36)
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)
The number of falls in the previous month
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)
Timed Up and Go (TUG) test - Cognitive
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)
Electroencephalography (EEG) during the Timed Up and Go (TUG) test - Cognitive
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)
Timed Up and Go (TUG) test - Manual
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)
Electroencephalography (EEG) during the Timed Up and Go (TUG) test - Manual
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)
Change in the gait speed (cm/s)
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)
Change in the cadence (step/min)
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)
Change in the stride length (cm)
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)
Change in the length of the centre of pressure (CoP)
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)
Change in the trajectory (mm)
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)
Change in the sway area (mm2)
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)
Change in the Brief Pain Inventory (BPI)
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)
Change in the Hospital Anxiety and Depression Scale
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)
Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
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)
Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D)
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)
Change in the Modified Asworth Scale
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)
Change in the Modified Tardieu Scale
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)
Change in the the Multiple Sclerosis Quality Of Life-54 (MSQOL-54)
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)
The EuroQol five domains (EQ-5D)
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)
The volumes of health services
Time frame: Before treatment (T0), and 24 weeks after the in-hospital treatment (T3)
The Multiple Sclerosis Health Resource Utilization Survey (MS-HRS)
Time frame: Before treatment (T0), and 24 weeks after the in-hospital treatment (T3)
The TheiTA Productivity Cost Questionnaire
Time frame: Before treatment (T0), and 24 weeks after the in-hospital treatment (T3)
Change in the Clinical Global Impression (CGI)
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)
Changes in effective brain connectivity through Electroencephalography (EEG)
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)
Change in the Brief Illness Perception Questionnaire (B-IPQ)
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)
Change in the Multidimensional Psychological Flexibility Inventory (MPFI)
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)
Change in the Self-Efficacy for Multiple Sclerosis Scale (SEMS)
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)
Tele-healthcare Satisfaction Questionnaire-Wearable Technology
Time frame: At the end of the 12 weeks of telerehabilitation
Patients' In-home Digital Telerehabilitation training experience questionnaire
Time frame: At the end of the 12 weeks of telerehabilitation
Activity levels through Technology-based Objective Measures (TOMS)
Time frame: 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)
Number of steps through Technology-based Objective Measures (TOMS)
Time frame: 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)
Distance traveled through Technology-based Objective Measures (TOMS)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 17388952Lassmann H, Bruck W, Lucchinetti CF. The immunopathology of multiple sclerosis: an overview. Brain Pathol. 2007 Apr;17(2):210-8. doi: 10.1111/j.1750-3639.2007.00064.x.
- Background: PubMed 8780061Lublin FD, Reingold SC. Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology. 1996 Apr;46(4):907-11. doi: 10.1212/wnl.46.4.907.
- Background: PubMed 23007702Lassmann H, van Horssen J, Mahad D. Progressive multiple sclerosis: pathology and pathogenesis. Nat Rev Neurol. 2012 Nov 5;8(11):647-56. doi: 10.1038/nrneurol.2012.168. Epub 2012 Sep 25.
- Background: PubMed 25772898Feinstein A, Freeman J, Lo AC. Treatment of progressive multiple sclerosis: what works, what does not, and what is needed. Lancet Neurol. 2015 Feb;14(2):194-207. doi: 10.1016/S1474-4422(14)70231-5.
- Background: PubMed 15456705Morgen K, Kadom N, Sawaki L, Tessitore A, Ohayon J, McFarland H, Frank J, Martin R, Cohen LG. Training-dependent plasticity in patients with multiple sclerosis. Brain. 2004 Nov;127(Pt 11):2506-17. doi: 10.1093/brain/awh266. Epub 2004 Sep 29.
- Background: PubMed 22986429Tomassini V, Matthews PM, Thompson AJ, Fuglo D, Geurts JJ, Johansen-Berg H, Jones DK, Rocca MA, Wise RG, Barkhof F, Palace J. Neuroplasticity and functional recovery in multiple sclerosis. Nat Rev Neurol. 2012 Nov 5;8(11):635-46. doi: 10.1038/nrneurol.2012.179.
- Background: PubMed 29313388Tieri G, Morone G, Paolucci S, Iosa M. Virtual reality in cognitive and motor rehabilitation: facts, fiction and fallacies. Expert Rev Med Devices. 2018 Feb;15(2):107-117. doi: 10.1080/17434440.2018.1425613. Epub 2018 Jan 10.
- Background: PubMed 32438326Peran P, Nemmi F, Dutilleul C, Finamore L, Falletta Caravasso C, Troisi E, Iosa M, Sabatini U, Grazia Grasso M. Neuroplasticity and brain reorganization associated with positive outcomes of multidisciplinary rehabilitation in progressive multiple sclerosis: A fMRI study. Mult Scler Relat Disord. 2020 Jul;42:102127. doi: 10.1016/j.msard.2020.102127. Epub 2020 May 6.
- Background: PubMed 30710580Lotze M, Ladda AM, Stephan KM. Cerebral plasticity as the basis for upper limb recovery following brain damage. Neurosci Biobehav Rev. 2019 Apr;99:49-58. doi: 10.1016/j.neubiorev.2019.01.027. Epub 2019 Jan 30.
- BackgroundSchmidt R, Lee T, Winstein C, et al. Motor control and learning: a behavioral emphasis. 2018. cited Sep. 17, 2022.,36
- Background: PubMed 36649574Gandolfi M, Mazzoleni S, Morone G, Iosa M, Galletti F, Smania N. The role of feedback in the robotic-assisted upper limb rehabilitation in people with multiple sclerosis: a systematic review. Expert Rev Med Devices. 2023 Jan;20(1):35-44. doi: 10.1080/17434440.2023.2169129. Epub 2023 Jan 29.
- Background: PubMed 31006692Dehem S, Montedoro V, Edwards MG, Detrembleur C, Stoquart G, Renders A, Heins S, Bruno D, Lejeune T. Development of a robotic upper limb assessment to configure a serious game. NeuroRehabilitation. 2019;44(2):263-274. doi: 10.3233/NRE-182525.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marialuisa Gandolfi principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Telerehabilitation (Euleria Home) and Conventional therapy in people with Progressive Multiple Sclerosis, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marialuisa Gandolfi, PhD (+390458124943, marialuisa.gandolfi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Timed Up and Go test (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485115, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024; AzTrials last refreshed its copy on 29 Oct 2026.