Reducing fear of falling in people with muscular dystrophy

Fear of Falling in Muscular Dystrophy: Investigation of the Phenomenon and a Multidisciplinary Rehabilitation Approach to Treat it

This study tests whether adding cognitive-behavioral therapy to motor rehabilitation helps people aged 16–65 with muscular dystrophy who have a persistent fear of falling.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: Universita di Verona (other)
• Locations: 1 site (Verona, verona)
• Trial ID: NCT07129954 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal participants are people aged 16–65 with a confirmed form of muscular dystrophy who can walk (FAC ≥1) and meet the MMSE cognitive screening cutoff, with those entering the intervention arm additionally having persistent fear of falling (FES-I ≥16).

Not a fit: Patients who are non-ambulatory (FAC <1), have significant cognitive impairment, cannot attend on-site rehabilitation, are already in other rehabilitation programs, or cannot adhere to treatment are unlikely to benefit from the interventions tested.

Why it matters

Potential benefit: If successful, combining CBT with motor rehabilitation could reduce fear of falling, lower fall rates, and improve daily function and quality of life for people with muscular dystrophy.

How similar studies have performed: CBT combined with physical rehabilitation has reduced fear of falling in older adults and some neurological conditions, but its specific effectiveness in muscular dystrophy is not well established and remains relatively novel.

Eligibility criteria

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 this trial is running

Verona, verona

• Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione — Verona, verona, Italy (RECRUITING)

Study contacts

• Study coordinator: Valentina Varalta, Doctor

Conditions: Fear of Falling, Duchenne Muscular Dystrophy, Muscular Dystrophies, Rehabilitation, Muscular Dystrophy