NCT06692296Recruiting
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Studio Pilota Sull'Efficacia Della Pedana Stabilometrica Nel Trattamento Del Paziente Con Atassia di Friedreich
Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 14 Nov 2024
- Start date
- 3 Feb 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- IRCCS Eugenio Medea
- Diseases
- Friedreich ataxia
- NCT number
- NCT06692296
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 3 Feb 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other associated neurological conditions;
- Current major psychiatric disorder (psychosis and major depression).
Age
- Age \< 14 years;
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy Coordinator of this site? Confirm its status | Pieve di Soligo | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.