Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia

Launched by IRCCS EUGENIO MEDEA · Nov 14, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special rehabilitation tool called the "Prokin 252" stabilometric platform can help improve balance in people with Friedreich's Ataxia, a condition that affects movement and coordination. The study will involve adolescents and adults aged 14 and older who have been genetically diagnosed with Friedreich's Ataxia and meet certain criteria related to their walking and standing abilities. Participants will be randomly placed into one of two treatment groups for four weeks and will be assessed three times: before the treatment starts, at the end of the four weeks, and again 90 days later through a telemedicine appointment.

Eligible participants will need to be able to walk at least 10 meters and stand without support, among other requirements. The goal is to see if the balance improvements from using the stabilometric platform last over time. This study is being conducted at the "La Nostra Famiglia" Association in Italy and is not yet recruiting participants. It aims to explore new rehabilitation options for people with Friedreich's Ataxia and will track changes in balance and movement abilities throughout the trial.

Gender

ALL

Eligibility 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).