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.
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 < 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;
Parallel
Balance training over stabilometric platform
BehavioralThe treatment using the stabilometric platform (a total of 20 sessions) generally includes an initial phase (approximately 5 minutes) of training and warm-up in "monitor" mode, during which the patient becomes familiar with the equipment. The patient then moves on to "training library" mode, which includes the following subcategories: (1) Stabilometric tracings in both static and dynamic phases (10 minutes); (2) Dexterity exercises in both static and dynamic phases (10 minutes); (3) Imbalance exercises in both static and dynamic phases (10 minutes). The goal during this phase is to increase the patient's stability limits and provoke balance reactions through load shifts in all directions. The session concludes with 10 minutes of TecnoBody Exergames, which help to automate the functions learned within a more complex activity.
Balance training by means of conventional rehabilitation
BehavioralConventional rehabilitation to improve balance includes an initial phase of tissue mobilization, particularly of the foot structures (approximately 5 minutes per foot), in order to prepare them for the subsequent activation phase. This is followed by a phase focused on activating the anti-gravity muscles and aligning the trunk within the chosen setting (10 minutes). The treatment continues with balance training, both static and dynamic, load transfers, and dual-task exercises using external references (15 minutes). The session concludes with functional exercises relevant to the patient's daily life context (10 minutes).
Score on the subscale 'Section E. Upright stability' of the modified Friedreich Ataxia Rating Scale.
The outcome evaluates balance performance while sitting, standing, and walking. Lower scores indicate better balance performance, higher scores indicate more severe balance impairment.
Modified Friedreich's Ataxia Rating Scale (mFARS)
Clinical assessment of severity for neurological deficits, specifically designed for patients affected by Friedreich's Ataxia. The maximum score is 93, with higher scores indicating more severe neurological deficit. mFARS includes four subscales, evaluating 'bulbar' function (cough and speech), upper limb coordination, lower limb coordination, and upright stability (sitting, standing, walking).
Scale for Assessment and Rating for Ataxia (SARA).
SARA is a semi-quantitative clinical assessment of cerebellar ataxia. It is composed by eight items: gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, heel shin slide. The final score ranges from zero (absence of ataxia) to 40 (severe ataxia).
Six minutes walking test (6MWT).
6MWT is a clinical assessment of gait endurance, by measuring the distance covered (metres) while walking on a straight even path (30 meters) for six minutes. According to original instructions, the patient is asked to walk along the path as fast as possible, taking turns at the edges of the path. Patients are allowed to walk autonomously or with assistive devices and to rest by standing.
Timed Up and Go test (TUG).
TUG evaluates mobility, balance, gait competence and fall risk. The test measures the time taken (seconds) to stand up from a standard armchair, walk three metres, turn and come back sitting. The patient cannot receive physical assistance during the test but is allowed to use assistive devices.
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