Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
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|ClinicalTrials.gov Identifier: NCT03507530|
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : April 27, 2018
|Condition or disease||Intervention/treatment|
|Neuromuscular Diseases Duchenne Muscular Dystrophy Dystrophy Dystrophy, Muscular||Other: Assessments|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Investigating The Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
- Other: Assessments
Falls related assessments, functional physical performance evaluations and quality of life assessments.
- 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.
- 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.
- Posture Analysis [ Time Frame: 15-20 minutes ]Posture analysis is made by using "New York Posture Rating Scale".
- Performance Evaluation [ Time Frame: 6 minutes ]6 minute walking test (6MWT) are used.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507530
|Contact: Canan İpek||+90-312-305 15 firstname.lastname@example.org|
|Ankara, Sıhhiye, Turkey, 06100|
|Contact: Graduate School of Health Sciences|
|Contact +90 (312) 305 10 90|