Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia

• ClinicalTrials.gov Identifier: NCT05981313
• Recruitment Status: Not yet recruiting
• First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Sponsor: Hasan Kalyoncu University
• Information provided by (Responsible Party): Tuğba GÖNEN, Hasan Kalyoncu University

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
Hemophilia; Hemophilia A; Hemophilia B

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

Groups and Cohorts

Group/Cohort
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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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

• Ages Eligible for Study: 4 Years to 17 Years (Child)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Hemophilia A and B disease is an X-linked recessive disease. Therefore, girls become carriers and do not show muscle joint problems.
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Pediatric group hemophilia A and hemophilia B children living in Gaziantep constitute the study population.

Criteria

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

Contacts

Contact: Tuğba GÖNEN, Asst. Prof.; 05050905846; tugba.badat@hku.edu.tr

Locations

Turkey

Hasan Kalyoncu University

Gaziantep, Şahinbey, Turkey, 27100

Sponsors and Collaborators

Hasan Kalyoncu University

More Information

Publications:

Srivastava A, Santagostino E, Dougall A, Kitchen S, Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J, Llinas A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3. No abstract available. Erratum In: Haemophilia. 2021 Jul;27(4):699.

Schafer GS, Valderramas S, Gomes AR, Budib MB, Wolff AL, Ramos AA. Physical exercise, pain and musculoskeletal function in patients with haemophilia: a systematic review. Haemophilia. 2016 May;22(3):e119-29. doi: 10.1111/hae.12909. Epub 2016 Apr 14.

De la Corte-Rodriguez H, Rodriguez-Merchan EC. The role of physical medicine and rehabilitation in haemophiliac patients. Blood Coagul Fibrinolysis. 2013 Jan;24(1):1-9. doi: 10.1097/MBC.0b013e32835a72f3.

Usgu S, Ramazanoglu E, Yakut Y. The Relation of Body Mass Index to Muscular Viscoelastic Properties in Normal and Overweight Individuals. Medicina (Kaunas). 2021 Sep 26;57(10):1022. doi: 10.3390/medicina57101022.

• Responsible Party: Tuğba GÖNEN, Assistant Professor, Hasan Kalyoncu University
• ClinicalTrials.gov Identifier: NCT05981313
• Other Study ID Numbers: 2023/52
• First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• 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, Hasan Kalyoncu University:

Hemophilia; Muscle tone; Stiffness; Elasticity

Additional relevant MeSH terms:

Hemophilia A; Hemophilia B; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked