Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia

Sponsor
Hasan Kalyoncu University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05981313
Collaborator
(none)
40
1
4.5
8.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia
    Anticipated Study Start Date :
    Aug 15, 2023
    Anticipated Primary Completion Date :
    Aug 16, 2023
    Anticipated Study Completion Date :
    Dec 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Hemophilia Group

    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

    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).

    Outcome Measures

    Primary Outcome Measures

    1. Lower extremity moscle tone (Hz) [through of the study, average 6 months]

      The tone (Hz) of lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) will be evaluated with MyotonPro device (Myoton Ltd). Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis and Tibialis Anterior muscle measurements will be made from the reference points determined in the supine relaxed position, while Biceps Femoris and Gastrocnemius measurements will be made in the prone position with the ankle in the neutral position. Participants will be allowed to rest on the table for 10 minutes before the measurements are taken. The viscoelastic measurement will be repeated three times by determining the reference points (cm) of the relevant muscles and the averages will be recorded. Only measurements with a coefficient of variation less than 3% will be taken into account, otherwise the measurements will be repeated.

    2. Lower extremity stiffness (N/m) [through of the study, average 6 months]

      The stiffness (N/m) of lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) will be evaluated with MyotonPro device (Myoton Ltd). Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis and Tibialis Anterior muscle measurements will be made from the reference points determined in the supine relaxed position, while Biceps Femoris and Gastrocnemius measurements will be made in the prone position with the ankle in the neutral position. Participants will be allowed to rest on the table for 10 minutes before the measurements are taken. The viscoelastic measurement will be repeated three times by determining the reference points (cm) of the respective muscles and the averages will be recorded. Only measurements with a coefficient of variation less than 3% will be taken into account, otherwise the measurements will be repeated.

    3. Lower extremity elasticity (log) [through of the study, average 6 months]

      The elasticity (log) of lower extremity muscles (Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Tibialis Anterior, Gastrocnemius) will be evaluated with MyotonPro device (Myoton Ltd). Vastus Medialis Obliquus, Rectus Femoris, Vastus Lateralis and Tibialis Anterior muscle measurements will be made from the reference points determined in the supine relaxed position, while Biceps Femoris and Gastrocnemius measurements will be made in the prone position with the ankle in the neutral position. Participants will be allowed to rest on the table for 10 minutes before the measurements are taken. The viscoelastic measurement will be repeated three times by determining the reference points (cm) of the respective muscles and the averages will be recorded. Only measurements with a coefficient of variation less than 3% will be taken into account, otherwise the measurements will be repeated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 17 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hasan Kalyoncu University Gaziantep Şahinbey Turkey 27100

    Sponsors and Collaborators

    • Hasan Kalyoncu University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tuğba GÖNEN, Assistant Professor, Hasan Kalyoncu University
    ClinicalTrials.gov Identifier:
    NCT05981313
    Other Study ID Numbers:
    • 2023/52
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tuğba GÖNEN, Assistant Professor, Hasan Kalyoncu University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2023