Studio Pilota Sull'Efficacia Della Pedana Stabilometrica Nel Trattamento Del Paziente Con Atassia di Friedreich

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy
RECRUITING
Pieve Di Soligo
Contact Information
Primary
Gabriella Paparella, Medical Degree
gabriella.paparella@lanostrafamiglia.it
00390438906330
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 24
Treatments
Experimental: Platform Group
Balance training including both conventional rehabilitation (24 sessions) and training over a stabilometric platform (20 sessions).
Active_comparator: Conventional Group
Balance training including only conventional rehabilitation (44 sessions).
Sponsors
Leads: IRCCS Eugenio Medea

This content was sourced from clinicaltrials.gov