Clinical trial NCT05981313: Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia
Official title: Evaluation of Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemophilia
Hemophilia A
Hemophilia B
Keywords: Hemophilia
Muscle tone
Stiffness
Elasticity
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 40
Sex: MALE
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric group hemophilia A and hemophilia B children living in Gaziantep constitute the study population.

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.

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.

Eligibility 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

Primary outcomes:
measure: Lower extremity moscle tone (Hz)
timeFrame: through of the study, average 6 months
measure: Lower extremity stiffness (N/m)
timeFrame: through of the study, average 6 months
measure: Lower extremity elasticity (log)
timeFrame: through of the study, average 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
state: Şahinbey
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.