Pulmonary and Upper Limb Functions in Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy Clinical Trial

Official title:

The Comparison of Pulmonary and Upper Extremity Functions Between Children With Duchenne Muscular Dystrophy and Healthy Peers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552874
• Other study ID #: GO 16/773
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: June 2018
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 31, 2018
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Duchenne Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Respiratory Function Test
• Upper Limb Function

Intervention

Other:
• The Performance of Upper Limb Questionnaire (PUL)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Test (PFT)	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.	5 minutes
Primary	The Performance Upper Limb (PUL)	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.	15 minutes