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Pulmonary and Upper Limb Functions in Duchenne Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT03552874
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Numan Bulut, Hacettepe University

Brief Summary:
Although it is known that the functions of pulmonary and upper limb is affected in late stage of Duchenne Muscular Dystrophy (DMD) negatively, the investigators do not have clear information about its early stage. The aim of this study was to investigate the differences in pulmonary and upper limb functions between children with DMD in early stage and healthy peers.

Condition or disease Intervention/treatment
Duchenne Muscular Dystrophy Upper Limb Function Respiratory Function Test Other: The Performance of Upper Limb Questionnaire (PUL)

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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Comparison of Pulmonary and Upper Extremity Functions Between Children With Duchenne Muscular Dystrophy and Healthy Peers
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : March 31, 2018


Group/Cohort Intervention/treatment
Patient Group
Children whose ages between 5-10 years with Duchenne Muscular Dystrophy.
Other: The Performance of Upper Limb Questionnaire (PUL)
Other Name: Pulmonary Function Test (PFT)

Healthy Group
Healthy peers
Other: The Performance of Upper Limb Questionnaire (PUL)
Other Name: Pulmonary Function Test (PFT)




Primary Outcome Measures :
  1. Pulmonary Function Test (PFT) [ Time Frame: 5 minutes ]
    The pulmonary function tests of the participants were evaluated with a spirometry. The child was asked to perform the spirometric tests for three times with maximum effort. The child was motivated before each attempt for stronger and longer expiration.The result of Pulmonary function Test were recorded.

  2. The Performance Upper Limb (PUL) [ Time Frame: 15 minutes ]
    Upper limb functions of participants were evaluated with The Performance of Upper Limb (PUL) scale. This scale, which was shown to be reliable in DMD, has 22 items in total. It consists of 3 different levels of function: high, mid, and distal. PUL also has four items determining timed performance.



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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is gender based because Duchenne Muscular Dystrophy is only seen in males.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Fourty seven participants including 31 children with DMD and 16 healthy peers were included
Criteria

Inclusion Criteria:

children with DMD was;

  • age between 5-10 years
  • being on treatment with corticosteroids for more than 6 months
  • being at Level I according to Brooke Upper and Lower Extremity Classification Systems

Healthy peers;

  • age between 5-10 years
  • not having any diagnosed disease

Exclusion Criteria:

• Children has undergo surgery and disease affect upper extremity or pulmonary function in last six months.


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Responsible Party: Numan Bulut, Department of Physiotherapy and Rehabilitation, Principal Investigator, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier: NCT03552874     History of Changes
Other Study ID Numbers: GO 16/773
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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