Fear of Falling in Muscular Dystrophy

NCT07129954 | Recruiting DMC

• 1 other identifier: 561CET
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

Fear of Falling; Muscular Dystrophy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Falls Efficacy Scale-International (FES-I)

  it allows us to identify the severity of the fear of falling. It consists of 16 questions directed to the patient, each of which can receive a score from 1 (=not at all concerned) to 4 (=very concerned). The scale range is from 16 to 64, where a lower score indicates less fear of falling. Specifically, a score between 16-19 indicates absent/mild fear of falling, between 20-27 moderate, and between 28-64 high (Morgan et al., 2013).

  The Falls Efficacy Scale - International (FES-I) will be administered at Baseline (T0), at 3 months (T1), at 6 months (T3), and at 9 months (T5).

Secondary Outcomes (12)

• North Star Ambulatory Assessment (NSAA)

  it will be administered at 3 months (T1).

• Posturographic examination

  It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).

• Amount of walking

  It will be measured one week before and one week after the rehabilitation intervention using a pedometer

• Falls history

  It will be collected at Baseline (T0).

• Barthel index (BI)

  It will be administered at Baseline (T0).

Study Arms (2)

Motor Rehabilitation

ACTIVE COMPARATOR

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

Behavioral: Motor rehabilitation

Motor rehabilitation + cognitive behavioral therapy

EXPERIMENTAL

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).

Behavioral: Motor Rehabilitation and Cognitive Behavioral Therapy

Interventions

Motor rehabilitation BEHAVIORAL

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

Motor Rehabilitation

Motor Rehabilitation and Cognitive Behavioral Therapy BEHAVIORAL

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.

Motor rehabilitation + cognitive behavioral therapy

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of muscular dystrophy: myotonic, facio-scapular-humeral, Becker, cingulate, Emery-Dreifuss, and distal;
• 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.
• \- 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, 37134, Italy

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Muscular Dystrophies

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Valentina Varalta, Doctor

CONTACT

045 8124956; valentina.varalta@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

IT (1)