Actively Recruiting
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Led by IRCCS Eugenio Medea · Updated on 2025-05-02
24
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older
- Weight less than 150 kg
- Genetic diagnosis of Friedreich's Ataxia
- Score between 1 to 6 on 'Gait' item of SARA scale
- Score between 1 to 3 on 'Stance' item of SARA scale
- Ability to walk at least 10 meters with or without walking aids
- Ability to stand unsupported
- Friedreich Ataxia Rating Scale stage between 2 and 4
You will not qualify if you...
- Younger than 14 years
- Diagnosis of acquired ataxia
- Score of 0 or 7 on 'Gait' item of SARA scale
- Score of 0 or 4 to 6 on 'Stance' item of SARA scale
- Inability to walk
- Ability to walk less than 10 meters
- Can only stand with support
- Other neurological conditions
- Current major psychiatric disorder such as psychosis or major depression
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy
Pieve di Soligo, Veneto, Italy, 31053
Actively Recruiting
Research Team
G
Gabriella Paparella, Medical Degree
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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