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Fear of Falling in Muscular Dystrophy | Clinical Trials | Clareo Health

RECRUITINGNA

Fear of Falling in Muscular Dystrophy

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

NCT07129954•Universita di Verona

View on ClinicalTrials.gov

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

Age

16 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, Italy

Key Dates

Start Date

July 2, 2025

Primary Completion Date

August 1, 2027

Completion Date

August 1, 2027

Last Updated

August 19, 2025

Enrollment

100

ESTIMATED participants

Conditions

Fear of FallingDuchenne Muscular Dystrophy (DMD)Muscular DystrophiesRehabilitation

Interventions

Motor rehabilitation

BEHAVIORAL

Motor Rehabilitation and Cognitive Behavioral Therapy

BEHAVIORAL

Contacts

Valentina Varalta, Doctor

CONTACT

045 8124956 valentina.varalta@univr.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fear of Falling in Muscular Dystrophy

Inclusion Criteria

Exclusion Criteria

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