Actively Recruiting

Phase Not Applicable
Age: 16Years - 65Years
All Genders
NCT07129954

Fear of Falling in Muscular Dystrophy

Led by Universita di Verona · Updated on 2025-08-19

100

Participants Needed

1

Research Sites

108 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fear of Falling in Muscular Dystrophy

Who Can Participate

Age: 16Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of muscular dystrophy: myotonic, facio-scapular-humeral, Becker, cingulate, Emery-Dreifuss, or distal
  • Age between 16 and 65 years
  • Residual walking ability with a functional ambulation category (FAC) of at least 1
  • Mini-Mental State Examination (MMSE) score corrected for age and education of at least 23.8 points
  • For specific treatment group: Fear of Falling score of at least 16 points on the Falls Efficacy Scale - International (FES-I) at 3 months
Not Eligible

You will not qualify if you...

  • Factors that make it unlikely for the participant to follow the treatment properly
  • Receiving care at other rehabilitation centers or participating in other research studies
  • Language barrier
  • Not signing informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, Italy, 37134

Actively Recruiting

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Research Team

V

Valentina Varalta, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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