NCT07129954Recruiting
Fear of Falling in Muscular Dystrophy
Fear of Falling in Muscular Dystrophy: Investigation of the Phenomenon and a Multidisciplinary Rehabilitation Approach to Treat it
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Primary objectives WP1: Evaluate the prevalence of FOF in the study population and how this varies over time. Evaluate whether there are relationships between the variables investigated (clinical, motor, cognitive, psychological) and the presence of FOF. WP2: To evaluate, among those who presented disabling FOF, the effects of two different therapeutic approaches: motor rehabilitation vs. motor rehabilitation plus cognitive-behavioral psychotherapy. Secondary objectives WP1: To evaluate whether different profiles defined by specific clinical, motor, cognitive, psychological, and personological characteristics can be characterized among patients with dystrophy and FOF and how these impact functionality, activity, participation, and quality of life. WP2: Evaluate the effects of cognitive-behavioral therapy (CBT) and a motor treatment on cognitive and psychological aspects, the frequency of falls, and the functional validity.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 11 Aug 2025
- Start date
- 2 Jul 2025
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Universita di Verona
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT07129954
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 2 Jul 2025 to the primary completion date, 1 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent management in other rehabilitation centers or participation in other research projects
Other illness
- Failure to sign informed consent.
Other
- The presence of factors that may lead to the assumption that it is a priori impossible to ensure adequate adherence to the proposed treatment;
- Language barrier;
Who the study is looking for
- 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);
Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.