Evaluation of Static Postural Balance in Children With Hemophilia and Its Relationship With Joint Health

NCT04406519 | Completed

• 1 other identifier: Necmettin Erb. Physiotherapy-3
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Hemophilia is a rare hematological disorder characterized by a partial or complete deficiency of clotting factor VIII or IX.Bleeding disorders mainly affect the musculoskeletal system. Intra-articular bleeding is an important complication related to hemophilia and usually occurs in large synovial joints such as knees and ankles. Initially, these bleeds occur non-specific spontaneously and usually affect one joint, and repeated bleeding makes that joint a target joint. Postural balance can be defined as the ability to maintain a stable posture for maximum duration with minimal body sway, or to hold the body centre of gravity (CoG) over its base support in varying conditions (1). Somatosensorial information from mechanoreceptors, visual and vestibular receptors is required to maintain postural balance. Postural balance is tried to be controlled by the postural adjustments provided by the contraction of the lower limb muscles and trunk muscles before perturbation. Spontaneous hemarthrosis is a distinctive feature of severe haemophilia, and that recurrent bleedings may likely to cause postural balance disorders by disrupting proprioceptive inputs from mechanoreceptors in the joint. Data on how bleeding affects postural balance in children with hemophilia is unclear.In the relationship between the clinical evaluation of hemophilia and postural balance, there is little research in the literature.

Conditions

Hemophilia; Arthropathy of Knee; Arthropathy of Ankle or Foot

Keywords

haemophilia; balance; joint health; arthropathy; children

Outcome Measures

Primary Outcomes (8)

• Hemophilia Joint Health Score

  The score for each index-joint range from 0 to 20 and the lower limb joint score from 0 to 80. A high score indicates that the joint health is worse.

  1 month

• Center of Pressure (CoP)- CoPX and CoPY

  Amplitude of CoP is the difference between the biggest and smallest CoP displacement for X-axis (CoPX) and Y-axis (CoPY), the smaller the score, the better the postural stability.

  1 month

• Velocity- Mediolateral (MLV) and Anteroposterior (APV)

  The velocity is calculated by dividing the CoP excursion by trial time and expressed in mm/sec. It reflects the effectiveness of the postural stability- the bigger the velocity indicates the worse the postural control.

  1 month

• Standard deviation of body sway- Mediolateral (MLSD) and Anteroposterior (APSD)

  The lower standard deviation in the body sway indicates that the postural balance is well.

  1 month

• Ellipse Area

  %90 of the total area scanned in the mediolateral and anteroposterior direction is calculated using an ellipse. A high score indicates that postural balance is worse

  1 month

• Perimeter

  Quantifies the size of the displacement based upon the total distance scanned in mm, and the higher the length of the scanned area considered that postural stability is poor

  1 month

• Muscle strength

  The flexors and extensors of the knee were measured by giving the resistance from proximal malleoli when the hip and knee were in 90° flexion during sitting position. The dorsi and plantar flexors of ankle were measured in the lower limb stabilized in supine position, giving resistance from the proximal of the metatarsophalangeal joint and was recorded in pounds.

  1 month

• Standard deviation of the trunk

  Total,anteroposterior and mediolateral standard deviation of the trunk were measured in degrees by the sensors. The lower standard deviation in the trunk sway indicates that the postural balance is well.

  1 month

Study Arms (2)

Hemophilia Group

The inclusion criteria in the hemophilia group were as follows; patients aged 6 to 18 years who developed HA in at least one of the lower limb joints due to severe haemophilia (total lower limb HJHS ≥3); to be receiving prophylaxis but have no major bleeding that could affect the musculoskeletal system in the past two weeks; and who did not perform regular physical activity and sports.

Control Group

The control group was consisted of healthy peers. The exclusion criteria in the control group were as follows: who had any auditory and visual impairment; who underwent orthopedic injuries including lower limb; and who had any neurological or cognitive impairment that could affect balance.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hemophilic children in Van province

You may qualify if:

• Aged 6 to 18 years
• Participants do not perform regular physical activity and sports.
• For hemophilia group who developed hemophilic arthropathy in at least one of the lower limb joints due to severe hemophilia (total lower limb hemophilia joint health score ≥3).
• For hemophilia group patients to be receiving prophylaxis but have no major bleeding that could affect the musculoskeletal system in the past two weeks

You may not qualify if:

• Have any auditory and visual impairment
• Undergo any orthopedic injuries including lower limb
• Have any neurological or cognitive disorders

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Yuzuncu Yil University

Van, Bardakcı, 65090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia A; Joint Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Diseases

Study Officials

• Ahmet Fayik Oner, Prof.

  Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology

  STUDY CHAIR

• Kamuran Karaman, Assoc. Prof.

  Van Yuzuncu Yil University Faculty of Medicine Dept of Pediatric Hematology

  STUDY DIRECTOR

• Seyhmus Kaplan, Assoc. Prof.

  Van Yuzuncu Yil University Faculty of Medicine Dept of Sports Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 28, 2020
• Study Start: February 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: May 15, 2019
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

TU (1)