Actively Recruiting
Fear of Falling in Muscular Dystrophy: Investigation of the Phenomenon and a Multidisciplinary Rehabilitation Approach to Treat It
Led by Universita di Verona · Updated on 2025-08-19
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the fear of falling (FOF) in people with muscular dystrophy, including types like myotonic, facio-scapular-humeral, Becker, cingulate, Emery-Dreifuss, and distal dystrophies. The study aims to understand how common FOF is in this group, how it changes over time, and how clinical, motor, cognitive, and psychological factors relate to FOF. It also evaluates two treatment approaches for those with disabling FOF: motor rehabilitation alone versus motor rehabilitation combined with cognitive-behavioral therapy. The study includes two treatment groups. One group receives motor rehabilitation sessions lasting 45 minutes each, with a total of 36 sessions focused on joint mobility, balance, gait training, proprioception, and use of special rehabilitation devices. The other group receives the same motor rehabilitation but fewer sessions (24 total) combined with weekly 45-minute cognitive-behavioral therapy (CBT) sessions over 12 weeks. CBT sessions work on identifying and changing thoughts and behaviors related to fear of falling. Participants will be assessed using various tools at baseline and multiple follow-up points up to nine months. The primary measure is the Falls Efficacy Scale-International (FES-I) to assess fear of falling. Secondary assessments include physical function tests, cognitive and psychological evaluations, walking activity monitored by pedometer, and quality of life surveys. The study will monitor how treatments affect fall frequency, cognitive and emotional health, and overall function.
CONDITIONS
Brief Title
Fear of Falling in Muscular Dystrophy
Who Can Participate
Eligibility Criteria
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 of at least 1
- Mini-Mental State Examination (MMSE) score corrected for age and education of at least 23.8 points
- For Work Package 2: persistent fear of falling at 3 months with a Falls Efficacy Scale-International (FES-I) score of 16 or higher
You will not qualify if you...
- Factors that make it impossible to ensure proper adherence to treatment
- Participation in other rehabilitation programs or research studies
- Language barriers preventing study participation
- Failure to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive motor rehabilitation sessions focusing on joint range maintenance, balance, gait training, proprioception, and scenic reinforcement. Some participants also receive additional cognitive behavioral therapy sessions targeting cognition, emotions, and behaviors related to fear of falling.
Multiple sessions per week totaling 36 sessions over 12 weeks
Duration - Up to 9 months post-baseline
Participants are assessed at multiple time points after treatment to evaluate physical and cognitive outcomes related to fear of falling and muscular dystrophy.
Assessments at 3, 6, and 9 months after baseline
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Verona, verona, Italy, 37134
Actively Recruiting
Research Team
V
Valentina Varalta, Doctor
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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