NCT06692296 Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
| NCT ID | NCT06692296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Friedreich Ataxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-02-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Gabriella Paparella, Medical Degree
PRINCIPAL INVESTIGATOR
Scientific Institute, IRCCS E. Medea, Department of Conegliano, Treviso, Italy.
Frequently Asked Questions
Who can join the NCT06692296 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Friedreich Ataxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06692296 currently recruiting?
Yes, NCT06692296 is actively recruiting participants. Contact the research team at gabriella.paparella@lanostrafamiglia.it for enrollment information.
Where is the NCT06692296 trial being conducted?
This trial is being conducted at Pieve di Soligo, Italy.
Who is sponsoring the NCT06692296 clinical trial?
NCT06692296 is sponsored by IRCCS Eugenio Medea. The principal investigator is Gabriella Paparella, Medical Degree at Scientific Institute, IRCCS E. Medea, Department of Conegliano, Treviso, Italy.. The trial plans to enroll 24 participants.