Viscoelastic Properties of Lower Extremity Muscles in Patients With Hemophilia

NCT ID: NCT05981313

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-15

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Hemophilia Hemophilia A Hemophilia B

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hasan Kalyoncu University

OTHER

Sponsor Role lead

Responsible Party

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Tuğba GÖNEN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hasan Kalyoncu University

Gaziantep, Şahinbey, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Tuğba GÖNEN, Asst. Prof.

Role: CONTACT

05050905846

References

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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.

Reference Type BACKGROUND
PMID: 32744769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27075748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23103725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34684059 (View on PubMed)

Other Identifiers

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2023/52

Identifier Type: -

Identifier Source: org_study_id

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