Fear of FallingNCT07129954
Fear of Falling in Muscular Dystrophy
A study testing Motor rehabilitation and Motor Rehabilitation and Cognitive Behavioral Therapy in people with Fear of Falling and Duchenne Muscular Dystrophy (DMD), run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Fear of Falling, Duchenne Muscular Dystrophy (DMD), Muscular Dystrophies
- What is being tested?
- Motor rehabilitation and Motor Rehabilitation and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jul 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Verona, verona, 37134
Valentina Varalta, Doctor, 045 8124956, valentina.varalta@univr.it
About this study
Official title: Fear of Falling in Muscular Dystrophy: Investigation of the Phenomenon and a Multidisciplinary Rehabilitation Approach to Treat it
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.
Read more
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.
- Being tested
- Motor rehabilitation, Motor Rehabilitation and Cognitive Behavioral Therapy
- Keywords
- Fear of Falling, Muscular Dystrophy, Rehabilitation
- Medical subject headings
- Muscular Dystrophy, Duchenne, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor rehabilitationBehavioural
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 TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Motor Rehabilitation | Active comparator | Motor rehabilitation will be characterized by sessions of 45 minutes each with a patient (total sessions 36) Receives: 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). Receives: Behavioral: Motor Rehabilitation and Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: It will be administered at 3 months (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start2 Jul 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of FallingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Varalta, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129954
- Sponsor's protocol ID
- 561CET
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of Falling in Muscular Dystrophy: Investigation of the Phenomenon and a Multidisciplinary Rehabilitation Approach to Treat it
- ClinicalTrials.gov ID
- NCT07129954
- Acronym / sponsor ID
- 561CET
- Keywords
- Fear of Falling, Muscular Dystrophy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Rehabilitation | Active comparator | Behavioral: Motor rehabilitationMotor rehabilitation will be characterized by sessions of 45 minutes each with a patient (total sessions 36) |
| Motor rehabilitation + cognitive behavioral therapy | Experimental | Behavioral: Motor Rehabilitation and Cognitive Behavioral Therapy1 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). |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor rehabilitationMotor 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 | Behavioural | Motor Rehabilitation |
| Motor Rehabilitation and Cognitive Behavioral Therapy1 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. | Behavioural | Motor rehabilitation + cognitive behavioral therapy |
Primary outcome
Falls Efficacy Scale-International (FES-I)
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).
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).
12 secondary outcomes
North Star Ambulatory Assessment (NSAA)
Time frame: it will be administered at 3 months (T1).
Posturographic examination
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
Amount of walking
Time frame: It will be measured one week before and one week after the rehabilitation intervention using a pedometer
Falls history
Time frame: It will be collected at Baseline (T0).
Barthel index (BI)
Time frame: It will be administered at Baseline (T0).
Montreal Cognitive Assessment (MoCA)
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
Trail Making Test (TMT)
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
Modified Five-Point Test (MFPT)
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
Beck Depression Inventory-II (BDI)
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
State-Trait Anxiety Inventory (STAI)
Time frame: It will be administered at 3 months (T1), 6 months (T3), and 9 months (T5).
The Big Five Observer (BFO)
Time frame: It will be administered at 3 months (T1).
Short Form Health Survey questionnaire (SF-36)
Time frame: It will be administered at 3 months (T1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
Related trials for Fear of Falling
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Recruiting
Effects of Balance Training in Individuals With Glaucoma
Glaucoma
Not yet recruiting
Effects of Otago Exercise Combined With Short-Foot Exercise in Older Adults
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor rehabilitation and Motor Rehabilitation and Cognitive Behavioral Therapy in people with Fear of Falling and Duchenne Muscular Dystrophy (DMD), run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Varalta, Doctor (045 8124956, valentina.varalta@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls Efficacy Scale-International (FES-I) (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.