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

RecruitingNAAges 14 Years - anyAllIRCCS Eugenio Medea
NCT06692296 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 14 years; * Weight \< 150 kg; * Genetic diagnosis of Friedreich's Ataxia; * Subscores of SARA (Scale for the Assessment and Rating of Ataxia) as follows: (1) from 1 to 6 for the item 'Gait (walking ability)'; (2) from 1 to 3 for the item 'Stance (ability to maintain a stable posture)'; (3) ability to walk ≥10 metres with or without walking aids; (4) ability to stand unsupported; Stadiation of the Friedreich Ataxia Rating Scale between 2 and 4. Exclusion Criteria: * Age \< 14 years; * Diagnosis of acquired ataxia; * Subscores for items on the SARA scale of: (1) 0 or 7 for gait; (2) 0 or 4-6 for stance; * Inability to walk; * Ability to walk \< 10 meters; * Standing position possible only with support; * Other associated neurological conditions; * Current major psychiatric disorder (psychosis and major depression).
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What it tests

  • Balance training over stabilometric platform
  • Balance training by means of conventional rehabilitation
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Where

1 site
Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy
Pieve di Soligo, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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