Reliability and Validity of the Turkish Version of the Upper Limb Short Questionnaire in Duchenne Muscular Dystrophy
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|ClinicalTrials.gov Identifier: NCT05274555|
Recruitment Status : Completed
First Posted : March 10, 2022
Last Update Posted : June 9, 2022
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Purpose: This study aimed to evaluate the construct validity and reliability of the Turkish version of the Upper Limb Short Questionnaire (ULSQ) in Duchenne muscular dystrophy (DMD).
Materials and methods: A total of 41 children with DMD have participated in the study. Upper and lower extremities functional levels were assessed with Vignos Scale and Brooke Upper Extremity Functional Rating Scale, respectively. The construct validity of the questionnaire was determined using the correlation between the ULSQ and ABILHAND-Kids. The Cronbach alpha value was calculated to determine internal consistency. To determine test-retest reliability, 17 randomly selected children were evaluated seven days after the first evaluation, and the "Intraclass Correlation Coefficient (ICC)" value was calculated.
|Condition or disease||Intervention/treatment|
|Duchenne Muscular Dystrophy Upper Extremity Problem||Other: Assessment|
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Official Title:||Reliability and Validity of the Turkish Version of the Upper Limb Short Questionnaire in Duchenne Muscular Dystrophy|
|Actual Study Start Date :||March 27, 2019|
|Actual Primary Completion Date :||April 25, 2021|
|Actual Study Completion Date :||June 29, 2021|
- Other: Assessment
The Upper Limb Short Questionnaire was administered by the researcher in face-to-face sessions with the children and their caregivers.
The lower extremity functions and ambulation levels of the children were evaluated by the researcher using the Vignos Scale.
The Brooke Upper Extremity Functional Rating Scale and ABILHAND-Kids were used to evaluate children's upper extremity functions.
- Upper Limb Short Questionnaire [ Time Frame: 2 years ]The Upper Limb Short Questionnaire consists of questions about UE function (5 items), pain (6 items), and stiffness (3 items). ULSQ can be used as an identifier of arm-hand limitations during the clinical investigation. The total score changes between 0 and 14. Lower scores present children have more problems in the upper extremities.
- ABILHAND-Kids [ Time Frame: 2 years ]That evaluates upper extremity function according to 18 different activities performed by children. The total score calculates by summing the grades that children get from each item and change between 0 and 36. Lower scores present lower ability while higher scores indicate higher ability of the hand/upper extremity in the ABILHAND-Kids.
- The Vignos Scale [ Time Frame: 2 years ]This scale classifies patients' walking abilities in 10 grades ranging from 1 to 10. At the first level, the patient can walk and climb the steps without assistance, but at the last level, patient is confined to bed.
- The Brooke Upper Extremity Functional Rating Scale [ Time Frame: 2 years ]It classifies upper extremity function with 6 different levels based on the children's upper extremity movements. Level 1 means patient can start the movement with the arms at the sides and fully joins the hands above the head, Level 6 is defined as unable to raise their hands to their mouths and cannot use their hands functionally.
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|Ages Eligible for Study:||5 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- being diagnosed with DMD, being between the ages of 5-18, not having any additional neurological disorder, volunteering to participate in the research
- patients diagnosed after 10 years of age, patients who had never taken corticosteroids, and patients aged 14 years or older but were still ambulatory
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): NCT05274555
|Dokuz Eylul University|
|Responsible Party:||Dilan Savaş, Physiotherapist, M.Sc., Dokuz Eylul University|
|Other Study ID Numbers:||
|First Posted:||March 10, 2022 Key Record Dates|
|Last Update Posted:||June 9, 2022|
|Last Verified:||June 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked