Reducing fear of falling in people with muscular dystrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project will first measure how common fear of falling is among people with various forms of muscular dystrophy and how it changes over time, relating it to clinical, motor, cognitive, and psychological measures. Participants aged 16–65 who can walk (FAC ≥1) and meet the cognitive screening cutoff are followed, with persistent disabling fear of falling (FES-I ≥16 at three months) qualifying them for WP2. In WP2, those with persistent fear are assigned to receive standard motor rehabilitation alone or motor rehabilitation plus cognitive-behavioral psychotherapy and outcomes such as fall frequency, psychological measures, and functional status are tracked. Secondary analyses will look for distinct patient profiles and the impact of treatments on activity, participation, and quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of muscular dystrophy: myotonic, facio-scapular-humeral, Becker, cingulate, Emery-Dreifuss, and distal;
* 16 to 65 years of age;
* Patients with residual walking capacity: functional ambulation category (FAC) at least equal to 1
* MMSE corrected for age and education of 23,8 points.

Specific Work Package 2 (WP2) inclusion criterion:

\- the persistence of Fear Of Falling at 3 months, identified as a score of at least 16 points at the Falls efficacy scale - International (FES-I);

Exclusion Criteria:

* The presence of factors that may lead to the assumption that it is a priori impossible to ensure adequate adherence to the proposed treatment;
* Concurrent management in other rehabilitation centers or participation in other research projects
* Language barrier;
* Failure to sign informed consent.

Where it's running

• Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
  Verona, verona, Italy Recruiting

Study contacts

• Study coordinator: Valentina Varalta, Doctor
• Email: valentina.varalta@univr.it
• Phone: 045 8124956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.