Fear of Falling in Muscular Dystrophy

University of Verona

Status: Enrolling

Conditions: Rehabilitation; Fear of Falling; Muscular Dystrophies; Duchenne Muscular Dystrophy (DMD)

Treatments: Behavioral: Motor rehabilitation; Behavioral: Motor Rehabilitation and Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07129954

561CET

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Motor Rehabilitation

Active Comparator group

Description:

Motor rehabilitation will be characterized by sessions of 45 minutes each with a patient (total sessions 36)

Treatment:

Behavioral: Motor rehabilitation

Motor rehabilitation + cognitive behavioral therapy

Experimental group

Description:

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).

Treatment:

Behavioral: Motor Rehabilitation and Cognitive Behavioral Therapy