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Reliability and Validity of the Turkish Version of the Upper Limb Short Questionnaire in Duchenne Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05274555
Recruitment Status : Completed
First Posted : March 10, 2022
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
Dilan Savaş, Dokuz Eylul University

Study Description
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Brief Summary:

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 Design
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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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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
Study Population
This study was planned as a methodological research. A total of 41 children with DMD between the ages of 5-18 were included in the study.
Criteria

Inclusion Criteria:

  • being diagnosed with DMD, being between the ages of 5-18, not having any additional neurological disorder, volunteering to participate in the research

Exclusion Criteria:

  • patients diagnosed after 10 years of age, patients who had never taken corticosteroids, and patients aged 14 years or older but were still ambulatory
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Turkey
Dokuz Eylul University
Izmir, Turkey
Sponsors and Collaborators
Dokuz Eylul University
More Information
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Responsible Party: Dilan Savaş, Physiotherapist, M.Sc., Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT05274555    
Other Study ID Numbers: 2019/07-65
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked