HemophiliaNCT06826209
Comparison of Upper Extremity Functional Performance in Hemophilic and Healthy Children
An observational study of Hemophilia and Upper Extremity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate the functional performance of the upper extremity joints (scapula, shoulder, elbow, and wrist) in haemophilic children and compare muscle strength and ADL limitations with healthy children. Read more about this study
- Who is it for?
- Ages 7 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia, Upper Extremity, Strength
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2024to 24 Oct 2026
- 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 7 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Male children diagnosed with Hemophilia, who are being followed by the same physician at the Hematology Unit of the Department of Pediatrics, Faculty of Medicine, Hacettepe University, will be included in the study
Who may be able to join
- Diagnosed with Hemophilia A or B
- Receiving prophylaxis treatment (a routine treatment)
- Negative for inhibitors at the time of enrollment
Who cannot join
- Positive for inhibitors at the time of enrollment
- Acute elbow bleeding
- History of acute muscle bleeding
- History of surgery in any upper extremity joints
- Having undergone radionuclide synovectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Upper Extremity Functional Performance, Muscle Strength, and Activities of Daily Living Levels in Children with Hemophilia and Healthy Children
The goal of this observational study is to evaluate the functional performance of the upper extremity joints (scapula, shoulder, elbow, and wrist) in haemophilic children and compare muscle strength and ADL limitations with healthy children.
Read the detailed description
This study aims to evaluate the upper extremity functional performance, muscle strength, and daily living activity levels of hemophilic children and compare them with healthy children. The goal is to determine the effects of hemophilia on these children and contribute to the development of appropriate rehabilitation strategies. Parameters include explosive strength, isometric muscle strength, wrist grip strength, and functional exercise capacity. Additionally, the ADL-Glittre pediatric version test and Hemophilia Joint Health Score (HJHS) will be used to assess joint health and GYA performance. Muscle strength is crucial for hemophilic children to perform daily activities, and the relationship between muscle strength and GYA levels will be investigated. The project aims to guide the development of physiotherapy and rehabilitation strategies for hemophilic children and contribute to the literature by filling existing gaps, ultimately creating an important reference for healthcare professionals and families.
- Conditions
- Hemophilia, Upper Extremity, Strength, Performance, Children
- Keywords
- Hemophilia, Muscle Strength, Upper Extremity
- Medical subject headings
- Hemophilia A
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 |
|---|---|---|
| Hemophilia groups | Patients group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemophilia Joint Health Score
The Hemophilia Joint Health Score (HJHS) is a clinical tool used to assess joint health in individuals with hemophilia, focusing on major joints such as the knees, elbows, and ankles. It evaluates symptoms like pain, swelling, and range of motion restrictions, with a grading system that helps determine the severity of joint damage. The HJHS also considers joint function in daily activities, making it an essential tool for monitoring joint health and the progression of hemophilic arthropathy. It plays a vital role in both clinical management and research, helping guide treatment strategies and assess their effectiveness.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Muscle Strength
The Lafayette Handheld Dynamometer is a device used to measure upper extremity muscle strength in children with hemophilia. It assesses muscle strength under isometric conditions and is typically used to test the muscles around the shoulder, elbow, and wrist. The measurements aim to determine the maximum force exerted by the muscles, which is important for identifying potential reductions in muscle strength in individuals with hemophilia. This test is valuable for determining physical performance levels, planning treatment approaches, and guiding rehabilitation processes.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start24 Oct 2024
- Primary completion24 Jun 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferhat Öztürk, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826209
- Sponsor's protocol ID
- FTREK24/103
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Upper Extremity Functional Performance, Muscle Strength, and Activities of Daily Living Levels in Children with Hemophilia and Healthy Children
- ClinicalTrials.gov ID
- NCT06826209
- Acronym / sponsor ID
- FTREK24/103
- Conditions
- Hemophilia, Upper Extremity, Strength, Performance, Children
- Keywords
- Hemophilia, Muscle Strength, Upper Extremity
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 24 Jun 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 13 Feb 2025 (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.
The goal of this observational study is to evaluate the functional performance of the upper extremity joints (scapula, shoulder, elbow, and wrist) in haemophilic children and compare muscle strength and ADL limitations with healthy children.
Detailed description
This study aims to evaluate the upper extremity functional performance, muscle strength, and daily living activity levels of hemophilic children and compare them with healthy children. The goal is to determine the effects of hemophilia on these children and contribute to the development of appropriate rehabilitation strategies. Parameters include explosive strength, isometric muscle strength, wrist grip strength, and functional exercise capacity. Additionally, the ADL-Glittre pediatric version test and Hemophilia Joint Health Score (HJHS) will be used to assess joint health and GYA performance. Muscle strength is crucial for hemophilic children to perform daily activities, and the relationship between muscle strength and GYA levels will be investigated. The project aims to guide the development of physiotherapy and rehabilitation strategies for hemophilic children and contribute to the literature by filling existing gaps, ultimately creating an important reference for healthcare professionals and families.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemophilia groups | – | –Patients group |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Male children diagnosed with Hemophilia, who are being followed by the same physician at the Hematology Unit of the Department of Pediatrics, Faculty of Medicine, Hacettepe University, will be included in the study
Key inclusion criteria (3 listed)
- Diagnosed with Hemophilia A or B
- Receiving prophylaxis treatment (a routine treatment)
- Negative for inhibitors at the time of enrollment
Key exclusion criteria (5 listed)
- Positive for inhibitors at the time of enrollment
- Acute elbow bleeding
- History of acute muscle bleeding
- History of surgery in any upper extremity joints
- Having undergone radionuclide synovectomy
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
Hemophilia Joint Health Score
Time frame: Through study completion, an average of 1 year
The Hemophilia Joint Health Score (HJHS) is a clinical tool used to assess joint health in individuals with hemophilia, focusing on major joints such as the knees, elbows, and ankles. It evaluates symptoms like pain, swelling, and range of motion restrictions, with a grading system that helps determine the severity of joint damage. The HJHS also considers joint function in daily activities, making it an essential tool for monitoring joint health and the progression of hemophilic arthropathy. It plays a vital role in both clinical management and research, helping guide treatment strategies and assess their effectiveness.
1 secondary outcome
Muscle Strength
Time frame: Through study completion, an average of 1 year
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 13 Feb 2025.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia and Upper Extremity, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 5 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: enrolling by invitation, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemophilia Joint Health Score (time frame: Through study completion, an average of 1 year). 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 13 Feb 2025.