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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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
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.
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Verona, verona, Italy
RECRUITINGFalls 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).
Time frame: 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).
North Star Ambulatory Assessment (NSAA)
to assess motor functionality. It is a scale consisting of 17 items that assess the performance of different functional skills, graded on a scale from 0 (unable), 1 (completed independently but with modifications), to 2 (completed without compensation. NSAA measures functional motor abilities in ambulant children with Duchenne Muscular Dystrophy (DMD). It is usually used to monitor the progression of the disease and treatment effects (Scott et al., 2012).
Time frame: it will be administered at 3 months (T1).
Posturographic examination
to assess postural abilities. During the posturographic examinations, the amount of body oscillation is determined by recording the Centre of Pressure (COP) displacements over a period (Verbecque et al., 2016). Utilizing a posturographic platform for quantitative analysis offers enhanced accuracy and a deeper understanding of the patient's functional status. TYMO® device, a portable posturography platform, is employed to measure the tilts of the body's center of mass and track the outcomes of the rehabilitation process. This tool facilitates an objective, straightforward, and quantitative evaluation of the patient's functional status. The evaluative exercises offer various tests, including weight distribution assessment in force or percentage, balance assessment, equilibrium control assessment, and step counting.
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
Amount of walking
to assess walking functionality. The amount of walking will be measured one week before and one week after the rehabilitation intervention using a pedometer. To ensure maximum accuracy, participants will wear a watch all day except at night to track the number of steps.
Time frame: It will be measured one week before and one week after the rehabilitation intervention using a pedometer
Falls history
to assess the number of falls in the previous 3 months and any related consequences. During the first assessment, patients will be asked about the presence and number of falls in the last 3 months and the consequences of these falls.
Time frame: It will be collected at Baseline (T0).
Barthel index (BI)
to assess the level of disability. The Barthel Index, a scale used to assess the level of disability, consists of 10 items related to common daily activities (feeding, dressing/grooming, personal hygiene, bathing/showering, bladder continence, transferring from chair to bed, using the toilet, mobility/ambulation on level ground, climbing or descending stairs), investigating the degree of patient dependence/independence. The score for each item can be 0 (=dependent), 5 (=requires assistance), or 10 (=independent), with a maximum possible score of 100. A score below 100 indicates the presence of dependence (Mahoney et al.,1965).
Time frame: It will be administered at Baseline (T0).
Montreal Cognitive Assessment (MoCA)
to assess cognitive global status. It is a screening tool for overall cognitive functioning consisting of 12 subtests exploring the following cognitive domains: memory (scores 0-5), visuospatial abilities (score 0-4), executive functions (score 0-4), attention, concentration, and working memory (score 0-6), language (score 0-6), spatial and temporal orientation (score 0-6). The total score ranges from 0 to 30, with higher scores indicating better cognitive functioning (Santangelo et al., 2015).
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
Trail Making Test (TMT)
to assess psychomotor speed, attentional set-shifting, and visual-spatial search speed. It is composed of two parts. In Part A, which investigates selective attention, the participant must connect 25 circled numbers (distributed in a standardized random layout) in ascending order. In Part B, which investigates attentional set-shifting, the participant must alternately connect circled numbers from 1 to 13 and circled letters from A to N (e.g., 1-A-2-B-3-C). There is also a third index consisting of the difference between the scores obtained in Part A and Part B, indicating psychomotor and visual-spatial search speed. The faster and more accurate the patient is, the more their performance will be within the norm (Siciliano et al., 2019).
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
Modified Five-Point Test (MFPT)
to assess visuospatial fluency by measuring the ability and speed to initiate a mental programming task and self-monitoring and visuospatial fluency. The result is based on the number of correct and unique drawings generated in 3 minutes (UDs) and the total number of drawings created according to a strategy (CSs) (Cattelani et al., 2011).
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
Beck Depression Inventory-II (BDI)
to assess depressive symptoms. It is a self-administered instrument that assesses the severity of depression in adult subjects. It consists of 21 items and yields a total score; a higher score indicates greater depressive symptoms (range 0-63). The scale includes different cut-offs depending on the severity of the symptoms: 0-13 mild depression, 14-19 moderate depression, 20-28 moderate depression, 29-63 severe depression (Montano, Flebus, 2006).
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
State-Trait Anxiety Inventory (STAI)
to assess anxiety symptoms. The questionnaire consists of 40 items to which the subject must respond in terms of perceived intensity on a Likert scale from 1 to 4 (higher scores indicating greater anxiety symptoms). The items are grouped into two scales. The first one investigates state anxiety, conceived as a particular experience of helplessness or insecurity in the face of perceived harm that can lead to worry or escape and avoidance. The second investigates trait anxiety, the tendency to perceive stressful situations as dangerous and threatening and to respond to various situations with varying intensity (Pedrabissi, Santinello, 1989).
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
The Big Five Observer (BFO)
to define personality traits. It is a sheet for observing and evaluating individual and organizational behaviors and social attitudes toward others. It can be used in any situation requiring hetero or self-assessment activities. The BFO is grounded in the theoretical framework of the psycholinguistic approach, using terms that are understandable even to non-psychologists. It consists of 40 pairs of opposite adjectives (8 for each Big Five: Extraversion-Introversion, Agreeableness-Disagreeableness, Conscientiousness-Negligence, Neuroticism-Emotional Stability, Openness-Closedness of Mind) selected from the Italian language vocabulary to be evaluated on a 7-point Likert scale (Caprara et al., 1994).
Time frame: It will be administered at 3 months (T1).
Short Form Health Survey questionnaire (SF-36)
to assess patient's quality of life. It is a popular instrument for evaluating Health-Related. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales contribute in different proportions to scoring PCS and MCS measures (Apolone \& Mosconi, 1998).
Time frame: It will be administered at 3 months (T1).
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