Neuromuscular DiseasesNCT03507530
Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
An observational study of Neuromuscular Diseases and Duchenne Muscular Dystrophy, run by Canan İpek at 1 site in Turkey (Türkiye).
Trial summary
For ambulatory children with DMD, physiotherapy is aimed at protecting ambulation, improving motor performance to the best level and increasing quality of life. The investigators think that the treatment of children with Duchenne Muscular Dystrophy may become more effective with physiotherapy programs based on the… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Neuromuscular Diseases, Duchenne Muscular Dystrophy, Dystrophy
- What is being tested?
- Assessments
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2018to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Duchenne Muscular Dystrophy, Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Neuromuscular Diseases Unit.
Who may be able to join
- Diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist,
- Being volunteer,
- Being between 6 and 15 years old,
- Being between levels 1-5 according to the Brooke Lower Extremity Functional Classification developed to classify lower extremity functions in children with DMD,
- Being able to cooperate with the physiotherapist's directives.
Who cannot join
- Being between levels 6-10 (children who do not have independent ambulatory ability) according to the Brooke Lower Extremity Functional Classification,
- Not being able to cooperate with the physiotherapist's directives,
- End of the volunteering.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Sıhhiye, 06100
Graduate School of Health Sciences
+90 (312) 305 10 90
About this study
Official title: Investigating The Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
For ambulatory children with DMD, physiotherapy is aimed at protecting ambulation, improving motor performance to the best level and increasing quality of life. The investigators think that the treatment of children with Duchenne Muscular Dystrophy may become more effective with physiotherapy programs based on the comprehensive physiotherapy evaluation results, including the evaluation of fear of falling. This study investigates the fear of falling in children with Duchenne Muscular Dystrophy and questioning whether their fear of falling affects their quality of life and their physical performance.
- Being tested
- Assessments
- Keywords
- physiotherapy and rehabilitation, fear of falling, quality of life
- Medical subject headings
- Neuromuscular Diseases, Muscular Dystrophy, Duchenne, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentsOther
Falls related assessments, functional physical performance evaluations and quality of life assessments.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Falling
"ICF Based 'Fear of Falling' Assessment in Pediatric Neuromuscular Diseases" is developed by researchers as examining the 'fear of falling' assessments in the literature and organizing the activities that children with Duchenne Muscular Dystrophy (DMD) may have experience fear of falling. There are six main titles which are based on DMD population and ICF headings. As follows: "Learning and Applying Knowledge", "General Tasks and Demands", "Mobility", "Self-Care", "Major Life Areas" and "Community, Social and Civic Living". It is a form total of 34 items which children with DMD answer to the fear of falling during different activities as "never = 0", "sometimes = 1", "always = 2" or "not applicable = NA". High scores indicate high fear of falling.
Measured: 15-30 minutes
Secondary outcomes (11)
History of Falls
Fall history of children with DMD is assessed using the 17-item History of Fall Questionnaire, which was developed by Ann Myers in 1996 and was later used to assess the fear of falling of individuals with Spinal Muscular Atrophy, a neuromuscular disease. Accordingly, past experiences of falling children are evaluated in sub-titles such as frequency, location, internal and external causes, injury.
Measured: 15-20 minutes
Posture Analysis
Posture analysis is made by using "New York Posture Rating Scale".
Measured: 15-20 minutes
Performance Evaluation
6 minute walking test (6MWT) are used.
Measured: 6 minutes
Evaluation of Energy Consumption
Physiological Cost Index is used to evaluate energy consumption. It reflects the increased heart rate required for walking and is expressed as heartbeats per meter by formula: [Heart rate after 6MWT- Heart rate at rest]/Walking speed (m/min).
Measured: 15-20 minutes
Fatigue
To evaluate the fatigue of the children with DMD, PedsQL Multidimensional Fatigue Scale is used. This scale assesses fatigue with a total of 18 items, 6 items in each of the 3 main headings: "General Fatigue", "Sleeping / Resting Fatigue" and "Cognitive Fatigue". There are three different forms for young children (5-7 years), children (8-12 years) and adolescents (13-17 years). All three forms have both child and parent reports. The reliability and validity of the scale is proven in Turkish.
Measured: 15-20 minutes
Balance Assessment
The Pediatric Berg Balance Scale is used to assess the functional balance in the daily activities of children with DMD. The scale consists of 14 sections and each section is scored between 0-4; the highest score that can be taken from the scale is 56 and the higher scores show the better balance level.
Measured: 15-20 minutes
Functional Walking Assessment
Gillette Functional Walking Scale is used for practical assessment of walking. The parent marks the item that best describes the child's ability to walk within 10 items. The high score means better walking ability.
Measured: 5-10 minutes
Gait Analysis
Spatio-temporal characteristics of gait are assessed. Step length, stride length, step width (width of the walking base) and stance width are measured by footprint method which we use talcum powder to make them appear.The walking speed are recorded according to the 6MWT results.
Measured: 15-20 minutes
Ambulation Assessment
The North Star Ambulatory Assessment which is a 17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy (DMD) is used. The activities are scored as follows:
2 - 'Normal' - no obvious modification of activity
1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently
Measured: 15-20 minutes
Quality of Life
The Pediatric Outcomes Data Collection Instrument is used for a comprehensive assessment of quality of life of children with DMD. Functional dimensions are assessed include upper extremity functioning, transfers and basic mobility, sports and physical function, comfort/pain, global function (an average of the four previous scores), and happiness with physical condition. Scores for all dimensions are scaled from 0 to 100, with 100 being the highest level of function or happiness.
Measured: 15-20 minutes
Activity Limitation
ACTIVLIM questionnaire is used which was designed to evaluate limitations in activities involving upper and lower limbs in adults and children with neuromuscular diseases, is linked to the domains of the Activities and Participation of the International Classification of Functioning, Disability and Health (ICF), and to its Children and Youth version (ICF-CY). There are 22 daily living activities and each item is answered on a 3-level scale (impossible, difficult, easy). The highest score that can be taken from the test is 44 and the higher scores indicate less activity limitation.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study startApr 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canan İpek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Canan İpek, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507530
- Sponsor's protocol ID
- GO 18/45
- Status last verified
- Apr 2018
- First submitted
- 8 Apr 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating The Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT03507530
- Acronym / sponsor ID
- GO 18/45
- Keywords
- physiotherapy and rehabilitation, fear of falling, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Canan İpekUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 25 Apr 2018 (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.
For ambulatory children with DMD, physiotherapy is aimed at protecting ambulation, improving motor performance to the best level and increasing quality of life. The investigators think that the treatment of children with Duchenne Muscular Dystrophy may become more effective with physiotherapy programs based on the comprehensive physiotherapy evaluation results, including the evaluation of fear of falling. This study investigates the fear of falling in children with Duchenne Muscular Dystrophy and questioning whether their fear of falling affects their quality of life and their physical performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Duchenne Muscular Dystrophy, Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Neuromuscular Diseases Unit.
Key inclusion criteria (5 listed)
- Diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist,
- Being volunteer,
- Being between 6 and 15 years old,
- Being between levels 1-5 according to the Brooke Lower Extremity Functional Classification developed to classify lower extremity functions in children with DMD,
- Being able to cooperate with the physiotherapist's directives.
Key exclusion criteria (3 listed)
- Being between levels 6-10 (children who do not have independent ambulatory ability) according to the Brooke Lower Extremity Functional Classification,
- Not being able to cooperate with the physiotherapist's directives,
- End of the volunteering.
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 |
|---|---|---|
| AssessmentsFalls related assessments, functional physical performance evaluations and quality of life assessments. | Other | – |
Primary outcome
Fear of Falling
Time frame: 15-30 minutes
"ICF Based 'Fear of Falling' Assessment in Pediatric Neuromuscular Diseases" is developed by researchers as examining the 'fear of falling' assessments in the literature and organizing the activities that children with Duchenne Muscular Dystrophy (DMD) may have experience fear of falling. There are six main titles which are based on DMD population and ICF headings. As follows: "Learning and Applying Knowledge", "General Tasks and Demands", "Mobility", "Self-Care", "Major Life Areas" and "Community, Social and Civic Living". It is a form total of 34 items which children with DMD answer to the fear of falling during different activities as "never = 0", "sometimes = 1", "always = 2" or "not applicable = NA". High scores indicate high fear of falling.
11 secondary outcomes
History of Falls
Time frame: 15-20 minutes
Posture Analysis
Time frame: 15-20 minutes
Performance Evaluation
Time frame: 6 minutes
Evaluation of Energy Consumption
Time frame: 15-20 minutes
Fatigue
Time frame: 15-20 minutes
Balance Assessment
Time frame: 15-20 minutes
Functional Walking Assessment
Time frame: 5-10 minutes
Gait Analysis
Time frame: 15-20 minutes
Ambulation Assessment
Time frame: 15-20 minutes
Quality of Life
Time frame: 15-20 minutes
Activity Limitation
Time frame: 5-10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases and Duchenne Muscular Dystrophy, run by Canan İpek at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Apr 2018. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Canan İpek (+90-312-305 15 76-77, cananipek@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Falling (time frame: 15-30 minutes). 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 27 Apr 2018.