Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295718
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-06
First Post:
2024-02-29
Brief Title:
Tele-assessment of Functional Performance and Quality of Life in Patients With Duchenne Muscular Dystrophy Validity and Reliability Study
Sponsor:
Sahra Şirvan
Organization:
Istanbul University
Study Overview
Official Title:
Tele-assessment of Functional Performance and Quality of Life in Patients With Duchenne Muscular Dystrophy Validity and Reliability Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thanks to tele-assessment methods it may be possible to evaluate DMD patients without traveling to clinical centers In recent years the applicability of remote assessment methods in DMD patients as in many populations is being investigated However studies have generally focused on a single evaluation parameter such as physical function a special evaluation method or a special evaluation tool The aim of this study is to investigate whether remote assessment of functional performance and quality of life in DMD patients is valid and reliable If a valid and reliable tele-evaluation method that includes functional performance and quality of life parameters is found to be valid and reliable the travel burden on patients and caregivers can be eased patients39 stress and anxiety related to travel can be reduced caregivers can save time and energy and provide patients with the best possible treatment
Detailed Description:
DMD is a progressive muscle disease that causes difficulties in mobility and impairment of vital functions as a result of X chromosome-linked dystrophin deficiency Symptoms appear between the ages of 3 and 5 and in untreated cases loss of ambulation occurs around the age of 8-12 Long sitting periods due to wheelchair use increase the risk of contracture osteopenia fracture and scoliosis and accompanying cardiorespiratory complications cause mortality in the early 20s in most cases Determining functional performance in DMD is a guide for determining appropriate treatment options and objectively evaluating the effectiveness of treatment However the evaluation methods applied are performed in clinical environments that require frequent travel and require both time and physical effort The aim of this study is to investigate whether remote assessment of functional performance and quality of life in DMD patients is valid and reliable For this purpose 20 volunteers diagnosed with DMD at Istanbul University-Cerrahpaşa Child Neurology Polyclinic and who meet the inclusion criteria will be evaluated in two ways online and face-to-face in terms of functional performance and quality of life parameters In addition scoring will be performed by two different physiotherapists during the evaluation and the reliability of the tele-evaluation among the evaluators will be examined Functional performance timed performance tests Brooke Upper Extremity Functional Classification and Vignos Lower Extremity Functional Classification Quality of life will be evaluated with PedsQL-30 Neuromuscular Module and PedsQL Multidimensional Fatigue Scale Thanks to valid and reliable tele-assessment methods for DMD patients travel burden can be alleviated for both patients and caregivers and disease-related stress and anxiety can be reduced In this way caregivers can save time and energy while providing the best care to patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None