Using a stabilometric platform to improve balance in Friedreich's Ataxia patients
Studio Pilota Sull'Efficacia Della Pedana Stabilometrica Nel Trattamento Del Paziente Con Atassia di Friedreich
This study is testing if using a special balance platform can help improve coordination and stability for people with Friedreich's Ataxia during rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Pieve di Soligo, Veneto) |
| Trial ID | NCT06692296 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an individualized rehabilitation intervention using the 'Prokin 252' stabilometric platform for patients with Friedreich's Ataxia. Participants will be randomly assigned to one of two treatment groups for four weeks, with assessments conducted before treatment, at the end of treatment, and 90 days post-treatment via telemedicine. The study aims to explore the platform's usefulness in combination with conventional therapy and to assess the retention of treatment effects over time. Friedreich's Ataxia is a progressive neurodegenerative disorder that significantly impacts balance and coordination, making effective rehabilitation crucial.
Who should consider this trial
Good fit: Ideal candidates are adolescents and adults aged 14 years and older with a genetic diagnosis of Friedreich's Ataxia and specific functional abilities.
Not a fit: Patients under 14 years old, those with acquired ataxia, or individuals unable to walk may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve balance and functional independence for patients with Friedreich's Ataxia.
How similar studies have performed: While this approach is exploratory, existing literature suggests that rehabilitation can play a critical role in managing ataxic syndromes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Pieve di Soligo, Veneto
- Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy — Pieve di Soligo, Veneto, Italy (Recruiting)
Study contacts
- Principal investigator: Gabriella Paparella, Medical Degree — Scientific Institute, IRCCS E. Medea, Department of Conegliano, Treviso, Italy.
- Study coordinator: Gabriella Paparella, Medical Degree
- Email: gabriella.paparella@lanostrafamiglia.it
- Phone: 00390438906330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.