NCT06826209

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2024Oct 2026

Study Start

First participant enrolled

October 24, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2026

Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

February 6, 2025

Last Update Submit

February 12, 2025

Conditions

Keywords

HemophiliaMuscle StrengthUpper Extremity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Muscle Strength

    Through study completion, an average of 1 year

Study Arms (1)

Hemophilia groups

Patients group

Eligibility Criteria

Age7 Years - 17 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • Diagnosed with Hemophilia A or B
  • Receiving prophylaxis treatment (a routine treatment)
  • Negative for inhibitors at the time of enrollment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Universit

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 13, 2025

Study Start

October 24, 2024

Primary Completion (Estimated)

June 24, 2026

Study Completion (Estimated)

October 24, 2026

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations