Fear of Falling in Muscular Dystrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-65
SponsorUniversita di Verona
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Motor rehabilitation
- Motor Rehabilitation and Cognitive Behavioral Therapy
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov