Actively Recruiting

Phase Not Applicable
Age: 14Years +
All Genders
ID06692296

Pilot Study on the Effectiveness of the Stabilometric Platform in Treating Patients with Friedreich's Ataxia

Led by IRCCS Eugenio Medea · Updated on 2025-05-02

24

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the potential benefits of an intensive, personalized rehabilitation program using the Prokin 252 stabilometric platform to improve balance in adolescents and adults with Friedreich's Ataxia, a progressive hereditary neurological condition causing coordination and balance problems. The study aims to explore how this technology combined with conventional therapy may help patients and to assess how well any treatment effects last over time. This is an exploratory, randomized, controlled, open-label study conducted at a single center with a prospective design. Participants will be randomly assigned to one of two groups for four weeks: one group will receive balance training combining conventional rehabilitation and the stabilometric platform, while the other group will receive only conventional rehabilitation. The stabilometric platform training includes exercises to improve stability and balance using static and dynamic phases, dexterity tasks, imbalance exercises, and interactive games. Conventional rehabilitation focuses on tissue mobilization, muscle activation, balance training, and functional exercises relevant to daily life. Each participant will undergo three assessments: before treatment (T0), at the end of treatment after four weeks (T1), and a follow-up via telemedicine 90 days after T1 (T2). Assessments include clinical scales measuring overall function and balance, such as the Modified Friedreich's Ataxia Rating Scale, Scale for Assessment and Rating of Ataxia, walking tests, and balance tests using the stabilometric platform. Researchers will track changes in these measures to evaluate treatment effectiveness and retention. The total study duration per participant includes the treatment period plus the follow-up assessment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 years or older
  • Weight less than 150 kg
  • Genetic diagnosis of Friedreich's Ataxia
  • SARA scale subscores: 1 to 6 for gait; 1 to 3 for stance
  • Ability to walk at least 10 meters with or without aids
  • Ability to stand unsupported
  • Friedreich Ataxia Rating Scale stage between 2 and 4
Not Eligible

You will not qualify if you...

  • Age under 14 years
  • Diagnosis of acquired ataxia
  • SARA scale subscores: 0 or 7 for gait; 0 or 4 to 6 for stance
  • Inability to walk
  • Ability to walk less than 10 meters
  • Standing only possible with support
  • Other neurological conditions
  • Current major psychiatric disorders such as psychosis or major depression

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive balance training either combining conventional rehabilitation with stabilometric platform sessions or conventional rehabilitation alone to improve standing balance.

24 sessions for combined treatment group and 44 sessions for conventional rehabilitation group

Follow-up

Duration - Approximately 3 months after treatment ends

Participants are reassessed via telemedicine to evaluate the lasting effects on balance and function after treatment completion.

1 telemedicine visit

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

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Research Team

G

Gabriella Paparella, Medical Degree

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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Published Research Related To This Trial

Quantitative Gait and Balance Outcomes for Ataxia Trials: Consensus Recommendations by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers.

Winfried Ilg, Sarah Milne, Tanja Schmitz-Hübsch...

https://pubmed.ncbi.nlm.nih.gov/37955812

Stabilometric assessment of context dependent balance recovery in persons with multiple sclerosis: a randomized controlled study.

Davide Cattaneo, Johanna Jonsdottir, Alberto Regola...

https://pubmed.ncbi.nlm.nih.gov/24912561

Brain changes associated with postural training in patients with cerebellar degeneration: a voxel-based morphometry study.

Roxana Gabriela Burciu, Nicole Fritsche, Oliver Granert...

https://pubmed.ncbi.nlm.nih.gov/23467375