Longitudinal gait and balance decline in Friedreich's Ataxia: A pilot study.
Theresa A Zesiewicz, Jeannie B Stephenson, Seok Hun Kim...
https://pubmed.ncbi.nlm.nih.gov/28411441Actively Recruiting
Led by IRCCS Eugenio Medea · Updated on 2025-05-02
24
Participants Needed
1
Research Sites
N/A
Total Duration
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
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy
Pieve di Soligo, Veneto, Italy, 31053
Actively Recruiting
G
Gabriella Paparella, Medical Degree
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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