Fear of Falling in Muscular Dystrophy

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Falls Efficacy Scale-International (FES-I) — 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).
  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).

Trial sites (1)

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