Fear of Falling in Muscular Dystrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-65
SponsorUniversita di Verona
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Crossover
Treatments tested in this trial
Motor rehabilitation
BehavioralMotor 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
Behavioral1 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Motor RehabilitationActive comparator 1 intervention
Group B: Motor rehabilitation + cognitive behavioral therapyExperimental treatment 1 intervention
Trial outcomes
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).
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).Secondary outcomes
1
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).2
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).3
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 pedometer4
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).Sponsors and contacts
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Source ClinicalTrials.gov