- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06826209
Comparison of Upper Extremity Functional Performance in Hemophilic and Healthy Children
February 12, 2025 updated by: Ferhat Öztürk, Hacettepe University
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.
Study Overview
Status
Enrolling by invitation
Conditions
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 Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06100
- Hacettepe Universit
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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
Yes
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- Diagnosed with Hemophilia A or B
- Receiving prophylaxis treatment (a routine treatment)
- Negative for inhibitors at the time of enrollment
Exclusion Criteria:
- 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
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 |
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Hemophilia groups
Patients group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength
Time Frame: Through study completion, an average of 1 year
|
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.
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Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
October 24, 2024
Primary Completion (Estimated)
June 24, 2026
Study Completion (Estimated)
October 24, 2026
Study Registration Dates
First Submitted
February 6, 2025
First Submitted That Met QC Criteria
February 12, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 12, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FTREK24/103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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.