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

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

      • Ankara, Turkey, 06100
        • Hacettepe Universit

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
Hemophilia groups
Patients group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Through study completion, an average of 1 year

Collaborators and Investigators

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

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

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.

Subscribe