Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy

NCT03507530 | Unknown

• 1 other identifier: GO 18/45
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Diseases; Duchenne Muscular Dystrophy; Dystrophy; Dystrophy, Muscular

Keywords

physiotherapy and rehabilitation; fear of falling; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  15-30 minutes

Secondary Outcomes (11)

• History of Falls

  15-20 minutes

• Posture Analysis

  15-20 minutes

• Performance Evaluation

  6 minutes

• Evaluation of Energy Consumption

  15-20 minutes

• Fatigue

  15-20 minutes

Interventions

Assessments OTHER

Falls related assessments, functional physical performance evaluations and quality of life assessments.

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canan İpek: lead

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases; Muscular Dystrophy, Duchenne; Muscular Dystrophies

Condition Hierarchy (Ancestors)

Nervous System Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Canan İpek

CONTACT

+90-312-305 15 76-77; cananipek@hacettepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: April 25, 2018
• Study Start: April 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)