Duchene's Muscular DystrophyNCT06750042
Analysis of Motor Performance in Children with Duchene's Muscular Dystrophy
An observational study of Duchene's Muscular Dystrophy, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Duchene's Muscular Dystrophy
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 27 Dec 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
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,
Who may be able to join
- 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.
Who cannot join
- any cognitive or neurological condition (other than Duchene's muscular Dystrophy),
- history of previous surgical operations that can affect pulmonary functions, and structural scoliosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Duchene's Muscular Dystrophy
- Keywords
- Duchene's muscular Dystrophy, Pulmonary Functions, Pediatrics, motor performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
motor performance
motor performance will be assessed by Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2)
Measured: measured for one time
respiratory function
respiratory function by Blue Cherry; Geratherm Respiratory. It is used to measure respiratory function to provide objective information for monitoring lung health.
Measured: measured for only one time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start27 Dec 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchene's Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed fekry ibrahim salman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750042
- Sponsor's protocol ID
- analysis of motor performance
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Motor Performance in Children with Duchene's Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT06750042
- Acronym / sponsor ID
- analysis of motor performance
- Conditions
- Duchene's Muscular Dystrophy
- Keywords
- Duchene's muscular Dystrophy, Pulmonary Functions, Pediatrics, motor performance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Dec 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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,
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- any cognitive or neurological condition (other than Duchene's muscular Dystrophy),
- history of previous surgical operations that can affect pulmonary functions, and structural scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
motor performance
Time frame: measured for one time
motor performance will be assessed by Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT™-2)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchene's Muscular Dystrophy, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Salman (+962797168340, a.salman@ammanu.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
motor performance (time frame: measured for one time). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.