Clinical Trial

Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia

Recruiting
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Summary
The primary objective is to evaluate the potential effectiveness of an individualized intensive rehabilitation intervention using the "Prokin 252" stabilometric platform in the treatment of adolescent and adult patients with Friedreich's Ataxia. The secondary objective is to assess the retention of the rehabilitation treatment effects over time. Enrolled patients will be randomized and assigned to one of two treatment groups for four weeks. Three assessments will be conducted for each patient: one before treatment (T0), one at the end of treatment (T1), and a follow-up assessment 90 days after T1 via telemedicine (T2). This study is: * Exploratory: The study aims to explore the usefulness of the stabilometric platform in a rehabilitative setting in combination with conventional therapy; * Not "first-in-human"; * Longitudinal: The study will investigate changes over time in motor and functional ability scales, as well as stabilometric platform parameters, within the same cohort; * Randomized, controlled, open-label; * Monocentric: The study will be conducted only at the "La Nostra Famiglia" Association in Conegliano and Pieve di Soligo - IRCCS Eugenio Medea in Conegliano - UOC Neuromotor Rehabilitation in Pieve di Soligo, Via Monte Grappa, 96, 31053 Pieve di Soligo TV; * Prospective; * Post-market.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-11-14; most recent amendment 2025-04-29.
Status change: Not Yet Recruiting → Recruiting 2025-04-29
Trial Details
NCT Number NCT06692296
Lead Sponsor IRCCS Eugenio Medea
Conditions Friedreich Ataxia
Enrollment 24 participants
Start Date 2025-02-03
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-02