- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507530
Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
Investigating The Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Canan İpek
- Phone Number: +90-312-305 15 76-77
- Email: cananipek@hacettepe.edu.tr
Study Locations
-
-
Sıhhiye
-
Ankara, Sıhhiye, Turkey, 06100
- Recruiting
- Hacettepe University
-
Contact:
- Graduate School of Health Sciences
-
Contact:
- Phone Number: +90 (312) 305 10 90
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15-30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
History of Falls
Time Frame: 15-20 minutes
|
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.
|
15-20 minutes
|
Posture Analysis
Time Frame: 15-20 minutes
|
Posture analysis is made by using "New York Posture Rating Scale".
|
15-20 minutes
|
Performance Evaluation
Time Frame: 6 minutes
|
6 minute walking test (6MWT) are used.
|
6 minutes
|
Evaluation of Energy Consumption
Time Frame: 15-20 minutes
|
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).
|
15-20 minutes
|
Fatigue
Time Frame: 15-20 minutes
|
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.
|
15-20 minutes
|
Balance Assessment
Time Frame: 15-20 minutes
|
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.
|
15-20 minutes
|
Functional Walking Assessment
Time Frame: 5-10 minutes
|
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.
|
5-10 minutes
|
Gait Analysis
Time Frame: 15-20 minutes
|
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.
|
15-20 minutes
|
Ambulation Assessment
Time Frame: 15-20 minutes
|
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 |
15-20 minutes
|
Quality of Life
Time Frame: 15-20 minutes
|
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.
|
15-20 minutes
|
Activity Limitation
Time Frame: 5-10 minutes
|
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.
|
5-10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 18/45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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