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Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia

H

Hasan Kalyoncu University

Status

Not yet enrolling

Conditions

Hemophilia B
Hemophilia A
Hemophilia

Study type

Observational

Funder types

Other

Identifiers

NCT05981313
2023/52

Details and patient eligibility

About

The aim of our study is to evaluate the viscoelastic properties of lower extremity muscles in patients with hemophilia A and hemophilia B secondarily to compare them with their healthy peers.

Full description

Hemophilia is a rare inherited coagulation disorder that develops as a result of factor VIII (hemophilia A) or factor IX (hemophilia B) deficiency, and is a chronic group of diseases that mainly manifests with intra-articular (hemarthrosis) and intramuscular (hematoma) bleeding, affecting quality of life. The presence of easy ecchymosis formation in early childhood, especially intra-articular and intramuscular spontaneous bleeding, interventions and a history of bleeding that lasted longer than expected after trauma should suggest hemophilia. The severity of bleeding findings is directly related to the degree of deficiency of hemophilia A and B. Hemarthroses due to bleeding in the joint (80%) and hematomas due to intramuscular bleeding (20%) cause joint degeneration and muscle atrophy. The joint in which hemarthrosis is most common is the knee joint, however, bleeding into the lower extremity muscles seriously affects the activities of daily living and lower extremity functionality. For this reason, the researchers aimed to evaluate the viscoelastic properties of lower extremity muscles in hemophilia patients and, secondarily, to compare them with their healthy peers.

Enrollment

40 estimated patients

Sex

Male

Ages

4 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children aged 4-17 years
  • Those who have been diagnosed with Hemophilia A and Hemophilia B by a physician
  • No history of acute bleeding
  • Children who have family consent and volunteer to participate in the study

Exclusion criteria

  • Those with a history of lower extremity surgery
  • Those with neurological disease
  • Those with a history of lower extremity hemarthrosis or hematoma in the last 1 month
  • Patients with inhibitor positive

Trial design

40 participants in 2 patient groups

Hemophilia Group
Description:
The viscoelastic properties (tone, stiffness, elasticity) of the lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) of hemophilia patients who meet the study criteria will be evaluated with the MyotonPro device (Myoton Ltd).
Control Group
Description:
The viscoelastic properties (tone, stiffness, elasticity) of the lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) of healthy children meeting the study criteria will be evaluated with the MyotonPro device (Myoton Ltd).

Trial contacts and locations

1

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Central trial contact

Tuğba GÖNEN, Asst. Prof.

Data sourced from clinicaltrials.gov

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