| NCT ID | NCT07129954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universita di Verona |
| Condition | Fear of Falling |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-02 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07129954 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 65 Years, studying Fear of Falling. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07129954 currently recruiting?
Yes, NCT07129954 is actively recruiting participants. Contact the research team at valentina.varalta@univr.it for enrollment information.
Where is the NCT07129954 trial being conducted?
This trial is being conducted at Verona, Italy.
Who is sponsoring the NCT07129954 clinical trial?
NCT07129954 is sponsored by Universita di Verona. The trial plans to enroll 100 participants.