RECRUITINGINTERVENTIONAL

Fear of Falling in Muscular Dystrophy

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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); Who Should NOT Join This Trial: - 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

Motor rehabilitation

Motor rehabilitation will be characterized by sessions of 45 minutes each with a patient (total sessions 36): physiotherapist ratio of 1:1. The rehabilitation project will be defined by the PM\&R specialist and the physiotherapist who will take charge of the patient. The treatment will focus on the maintenance of active and passive joint ranges, on the training of balance and gait, and on exercises of proprioception and scenic reinforcement. Specific devices (rehabilitation beds, verticalizer, posturography platform) will be used during motor treatment

BEHAVIORAL

Motor Rehabilitation and Cognitive Behavioral Therapy

1 session per week of 45 minutes of cognitive behavioral therapy and 2 sessions per week of 45 minutes of motor rehabilitation. The length of the treatment is the same as the control group: 12 weeks for 12 CBT sessions and 24 motor rehabilitation sessions (a total of 36 sessions). Motor rehabilitation will be the same as that provided to the control group. In addition, participants will receive Cognitive-Behavioral Therapy (CBT), consisting of individual 45-minute sessions (one psychotherapist per patient). The sessions will focus on the relationship between cognition, emotions, and behavior. Specifically, the therapist will work with the patient to identify and modify automatic thoughts, cognitive distortions, and underlying beliefs or patterns associated with the fear of falling.

Locations (1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, Italy