protocolSection identificationModule nctId: NCT06274281, orgStudyIdInfo id: TOMs_FMD, briefTitle: Digital Telerehabilitation in Functional Motor Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Universita di Verona, class: OTHER, descriptionModule briefSummary: Functional motor disorders (FMDs) are a broad spectrum of functional neurological disorders, including abnormal gait/balance disorders. Patients experience high degrees of disability and distress, equivalent to those suffering from degenerative neurological diseases. Rehabilitation is essential in their management. However, the current systems of rehabilitation delivery face two main challenges. Patients are not receiving the amount and kind of evidence-based rehabilitation they need due to the lack of rehabilitation professionals and experts in the field. The rehabilitation setting is not adequate for the long-term management and monitoring of these patients. Digital medicine is a new field that means "using digital tools to upgrade the practice of medicine to one that is high-definition and far more individualized." It can upgrade rehabilitation practice, addressing the existing critical components towards marked efficiency and productivity. Digital telerehabilitation will increase the accessibility to personalized rehabilitation by expert professionals placing tools to monitor the patient's health by themselves.The increasing development and availability of portable and wearable technologies are rapidly expanding the field of technology-based objective measures (TOMs) in neurological disorders. However, substantial challenges remain in (1) recognizing TOMs relevant to patients and clinicians to provide accurate, objective, and real-time assessment of gait and activity in a real-world setting and (2) their integration into telerehabilitation systems towards a digital rehabilitation transition.This feasibility study provides preliminary data on the integration of a real-time gait and activity analysis by wearable devices in the real world with a digital platform to improve the diagnosis, monitoring, and rehabilitation of patients with FMDs., conditionsModule conditions: Functional Movement Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is an experimental single-blind randomized-controlled trial (RCT) with 2-parallel arms comparing the effects between the experimental group (EG) and control group (CG). After screening, a simple randomization list will be generated by a physician using an automated randomization system (alloca-tion ratio 1:1) to assign eligible patients to either the EG or the CG. Group allocation will be kept concealed., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The outcome assessor will be blinded to the type of intervention performed by the patient., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Digital Telerehabilitation, interventions name: Usual care, outcomesModule primaryOutcomes measure: number of patients who accept/refuse the treatment, physiotherapy compliance and falls or event near falling occurred during rehabilitation, primaryOutcomes measure: Budget issues related to TOMs, primaryOutcomes measure: Time spent to train patients, secondaryOutcomes measure: Change in the Simplified Functional Movement Disorders Rating Scale (S-FMDRS) score, secondaryOutcomes measure: Multidimensional Fatigue Inventory Scale (MFI-20) score, secondaryOutcomes measure: Change in the Brief Pain Inventory (BPI) score, secondaryOutcomes measure: Change in the Beck Depression Inventory (BDI-II) score, secondaryOutcomes measure: Change in the Beck Anxiety Inventory (BAI) score, secondaryOutcomes measure: Change in the 12-item Short-Form Health Survey (SF-12) score, secondaryOutcomes measure: The EuroQol-5D (EQ-5D), secondaryOutcomes measure: iMTA Productivity Cost Questionnaire, secondaryOutcomes measure: Change in the Clinical Global Impression (CGI) score, secondaryOutcomes measure: Gait outcome: Gait speed, secondaryOutcomes measure: Gait outcome: Stride length, secondaryOutcomes measure: Gait outcome: Cadence, secondaryOutcomes measure: Balance outcome: CoP trajectory, secondaryOutcomes measure: Balance outcomes: Sway area, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, city: Verona, zip: 37131, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, locations facility: USD Parkinson's Disease and Movement Disorders Unit, city: Verona, zip: 37134, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False