Analysis of Motor Performance in Children with Duchene's Muscular Dystrophy

December 25, 2024 updated by: Ahmed fekry ibrahim salman, Cairo University
25 boys, ages ranging from 6 to 16 years, diagnosed with Duchene's muscular Dystrophy (DMD) will participated in the study. They will be selected from the Pediatric Rehabilitation Center of Deraya University's outpatient clinic in El-Minia district, Minia-Egypt. The outcome will be assessed motor performance will be assed by Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2) : balance, running speed and agility, bilateral coordination and strength and by Blue Cherry; Geratherm Respiratory. It is used to measure vital capacity (VC), forced expired volume in one second (FEV1), FEV1/FVC, FEV1/VC, and peak expiratory flow (PEF) to provide objective information for monitoring lung health.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

25 ages ranging from 6 to 16 years, diagnosed with Duchene's muscular Dystrophy will participate in this study. They were selected from Pediatric rehabilitation center of Deraya university out-patient clinic in El-Minia district, Minia,

Description

Inclusion Criteria:

  • the diagnosis is Duchene's muscular Dystrophy only not other types,
  • ambulated with or without assistance,
  • oriented and endurance enough to understand orders to perform ventilation on the Blue Cherry; Geratherm Respiratory device.

Exclusion Criteria:

  • any cognitive or neurological condition (other than Duchene's muscular Dystrophy),
  • history of previous surgical operations that can affect pulmonary functions, and structural scoliosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Duchene's muscular Dystrophy
age ranging from 6 to 16 years, diagnosed with Duchene's muscular Dystrophy (DMD) will participate in the study. They will be selected from the Pediatric Rehabilitation Center of Deraya University's outpatient clinic in El-Minia district, Minia-Egypt.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
motor performance
Time Frame: measured for one time
motor performance will be assessed by Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2)
measured for one time
respiratory function
Time Frame: measured for only one time
respiratory function by Blue Cherry; Geratherm Respiratory. It is used to measure respiratory function to provide objective information for monitoring lung health.
measured for only one time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 27, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 25, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • analysis of motor performance

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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