EMS_Rehab
What it found
No result yet.
What was tested
Treatment tested
- Vestibular Physical Therapy
What it measured
Main measures
Mini-BESTest
Baseline (T0), after first intervention period (T1; 4 weeks), and after crossover (T2; 8 weeks).
Walking and mobility
Other measures (7)
Neuroimaging (MRI)
Baseline (T0), after first intervention period (T1; 4 weeks), and after crossover (T2; 8 weeks).
MRI lesionsWalking and mobilityNerve conduction testsBerg Balance Scale (BBS)
Baseline (T0), after first intervention period (T1; 4 weeks), and after crossover (T2; 8 weeks).
Walking and mobilityDizziness Handicap Inventory (DHI)
Baseline (T0), after the first intervention period (T1; 4 weeks), and after the crossover intervention (T2; 8 weeks).
Walking and mobilityActivities-specific Balance Confidence (ABC) Scale
Baseline (T0), after the first intervention period (T1; 4 weeks), and after the crossover intervention (T2; 8 weeks).
Walking and mobilityFatigue Severity Scale
Baseline (T0), after the first intervention period (T1; 4 weeks), and after the crossover intervention (T2; 8 weeks).
FatigueInertial Measurement Unit (IMU)-derived Gait Parameters
Baseline (T0), after the first intervention period (T1; 4 weeks), and after the crossover intervention (T2; 8 weeks).
Walking and mobilityIMU-derived Gait Parameters
Baseline (T0), after the first intervention period (T1; 4 weeks), and after the crossover intervention (T2; 8 weeks).
Walking and mobility
Who could take part
Relapsing MS · 18 to 65
Inclusion Criteria: * people with Relapsing-Remitting Multiple Sclerosis; * All participants must be ambulatorial (EDSS ≤2.5); Exclusion Criteria: * relapse or medication changes in the prior 6 months; * people with peripheral vestibular disorders; * people with contraindications to MRI. We will also recruit 30 healthy volunteers, matched for age and sex, who will complete the assessment protocol once, to serve as a comparison group for individuals with MS.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
Background Many people with Multiple Sclerosis (MS) experience a hidden yet clinically significant symptom: impaired balance or a persistent feeling of instability, even during the early stages of the disease (Martin et al., 2006). Although these individuals may appear to walk normally, they often report feeling unsteady, avoiding crowded environments, or fearing falls. In some cases, however, balance deficits become overt and disabling, depending on the location and extent of lesions within the central nervous system. This heterogeneity complicates both the assessment and treatment of balance disorders in MS and highlights the need for personalized evaluation and rehabilitation strategies (Carpinella et al., 2022). Because early balance impairments are often subtle, they tend to be underestimated in clinical practice and may remain untreated for months or even years. This delay can negatively affect confidence, mobility, safety, and overall quality of life. The present project seeks to address this gap by promoting early identification and intervention before substantial disability develops. Project Objectives The objectives of this project are: To identify the mechanisms underlying early balance impairment in people with MS. To develop and evaluate an early intervention based on Vestibular Physical Therapy (VPT) that specifically targets sensory reweighting and visuo-vestibular integration. The rehabilitation program is designed to improve gaze stability and saccadic velocity, both of which are essential for maintaining postural control and dynamic balance. In addition, functional magnetic resonance imaging (fMRI) will be used to investigate the neurophysiological mechanisms underlying the intervention, providing insight into how the brain adapts to vestibular stimulation. If successful, this approach could enable clinicians to detect and treat balance impairments at an earlier stage, using objective and measurable changes in gait and brain function as biomarkers of rehabilitation efficacy. Methodology The study will recruit two groups of participants: Individuals diagnosed with Multiple Sclerosis (Thompson et al., 2018; Wallace et al., 2025) with mild disability (Expanded Disability Status Scale, EDSS ≤ 2.5) who report balance complaints. Healthy volunteers matched for age and sex. At baseline (T0), all participants will undergo a comprehensive assessment including: Structural and functional MRI with vestibular stimulation to investigate the integrity and functional organization of the vestibular network. Instrumented gait analysis using wearable inertial sensors (Castiglia et al., 2025). Validated clinical scales and questionnaires assessing objective balance performance, perceived stability, fear of falling, fall risk, and health-related quality of life. Participants with MS will then be randomly assigned to one of two groups: Intervention group: Participants will receive a structured Vestibular Physical Therapy (VPT) program consisting of 12 sessions (three sessions per week). Unlike conventional vestibular rehabilitation, this protocol specifically focuses on sensory reweighting and visuo-vestibular integration to enhance gaze stability, saccadic velocity, and postural control. Control group: Participants will continue receiving standard clinical care for MS without additional vestibular rehabilitation during the initial study phase. Following completion of the 12-session intervention, all participants will repeat the full assessment battery (T1) to evaluate changes in gait performance, balance, patient-reported outcomes, and brain function. After a 4-week washout period, a crossover design will be implemented, with participants switching to the alternate treatment arm for an additional 12-session period, followed by a final assessment (T2). Participants initially assigned to the control group will not require a washout period before crossing over to the intervention, as they will not have received VPT during the first phase of the study.
Papers
Background
Tramontano M, Paolocci G, Piatti D, Attanasio G, Casagrande Conti L, Bergamini E, Manzari L, Lacquaniti F, Staab JP, Bosco G, Indovina I. Dynamic postural stability, symmetry, and smoothness of gait in patients with persistent postural-perceptual dizziness. J Vestib Res. 2025 Mar;35(2):82-90. doi: 10.1177/09574271241295615. Epub 2024 Nov 6.Background
Piatti D, Paolocci G, Verdecchia DH, Grasso MG, Bosco G, Indovina I, Tramontano M. Effectiveness of vestibular physical therapy on balance and dizziness in people with multiple sclerosis: A systematic review and meta-analysis. J Vestib Res. 2026 May 5:9574271261444952. doi: 10.1177/09574271261444952. Online ahead of print.Background
Caronni A, Gervasoni E, Ferrarin M, Anastasi D, Brichetto G, Confalonieri P, Di Giovanni R, Prosperini L, Tacchino A, Solaro C, Rovaris M, Cattaneo D, Carpinella I. Local Dynamic Stability of Gait in People With Early Multiple Sclerosis and No-to-Mild Neurological Impairment. IEEE Trans Neural Syst Rehabil Eng. 2020 Jun;28(6):1389-1396. doi: 10.1109/TNSRE.2020.2991636. Epub 2020 Apr 30.
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History
Started
Oct 2026
Main results due
Oct 2028
Finished
Oct 2029
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