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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
Sponsor:
Information provided by (Responsible Party):
Canan İpek, Hacettepe University

Tracking Information
First Submitted Date April 8, 2018
First Posted Date April 25, 2018
Last Update Posted Date April 27, 2018
Estimated Study Start Date April 2018
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03507530 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 15, 2018)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
Official Title Investigating The Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy
Brief 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 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with Duchenne Muscular Dystrophy, Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Neuromuscular Diseases Unit.
Condition
  • Neuromuscular Diseases
  • Duchenne Muscular Dystrophy
  • Dystrophy
  • Dystrophy, Muscular
Intervention Other: Assessments
Falls related assessments, functional physical performance evaluations and quality of life assessments.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 15, 2018)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Canan İpek +90-312-305 15 76-77 cananipek@hacettepe.edu.tr
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03507530
Other Study ID Numbers GO 18/45
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Canan İpek, Hacettepe University
Study Sponsor Canan İpek
Collaborators Not Provided
Investigators Not Provided
PRS Account Hacettepe University
Verification Date April 2018