NCT05879549

Brief Summary

Hemophilia is a bleeding disorder caused by a deficiency of clotting factors in the blood. Muscle and joint bleeding are frequently observed in patients with hemophilia. Lower extremity bleeding can adversely affect balance, gait, and proprioception. The goal of this study; To compare the effectiveness of closed kinetic chain exercises and proprioceptive exercises on balance, proprioception and gait parameters in adolescent and young hemophilic individuals with lower extremity joint involvement. The main question it aims to answer is: Are the effects of closed kinetic chain exercises and proprioceptive exercises different on balance and walking in hemophilic individuals?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

May 5, 2023

Last Update Submit

June 20, 2025

Conditions

Keywords

hemophiliaexercisebalanceproprioception

Outcome Measures

Primary Outcomes (3)

  • Medio-lateral and Anterior-posterior stability index

    Represents fluctuations from the horizontal around the mediolateral axis. Mediolateral sway and anterior-posterior stability will record in the double-leg stance for 20 seconds with Biodex Balance System. The feet are placed in a comfortable position for patients, and the center of gravity was recorded in the system to begin the test. Each test will repeat 3 times. A higher sway index indicates a decrease in postural stability.

    12 weeks

  • walking speed

    A 10-meter walking test will be used to evaluate walking.

    12 weeks

  • Hemophilia joint health score

    The HJHS is derived from a physical examination of the index joints by a health care professional who should have training and expertise in the conduct of a detailed musculoskeletal (MSK) examination. It is a measure of joint health and sits within the World . The current HJHS version 2.1 comprises an assessment of specific features, or items, of the six index joints and an assessment of global gait. For each of the six joints, the following items are scored: swelling (scored 0-3), duration of swelling (0-1), muscle atrophy (0-2), crepitus on motion (0-2), flexion loss (0-3), extension loss (0-3), joint pain (0-2), and strength (0-4). The maximum score for an individual index joint is 20. Gait is scored 0 to 4. The maximum HJHS total score is 124, with a higher score indicating worse joint health.

    12 weeks

Secondary Outcomes (3)

  • Single leg stance test

    12 weeks

  • Proprioception

    12 weeks

  • 2-dimensional video-based gait kinematic analysis

    12 weeks

Study Arms (3)

Closed Chain Exercise Group

EXPERIMENTAL

Closed kinetic chain exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks.

Other: Closed Chain Exercise Group

Proprioceptive Exercise Group

EXPERIMENTAL

Proprioceptive exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks.

Other: Proprioceptive Exercise Group

Control Group

NO INTERVENTION

No intervention will be applied.

Interventions

Closed Chain Exercise Group

Closed Chain Exercise Group

Proprioceptive Exercise Group

Proprioceptive Exercise Group

Eligibility Criteria

Age13 Years - 25 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Having been diagnosed with Hemophilia A and Hemophilia B
  • Having a blood factor level below 5%,
  • Between 13-25 years old
  • History of bleeding to the lower extremity and target joint
  • Total lower extremity Hemophilia joint health score ≥3
  • Using prophylaxis

You may not qualify if:

  • Having undergone lower extremity surgery in the last 6 months
  • Having a Body Mass Index over 30 kg/m2
  • Have an inhibitor
  • Using a walking aid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Tat NM, Tat AM, Oner AF, Karaman K, Kaplan S, Can F. Static postural balance evaluation and an investigation of the relationship with joint health in children with severe haemophilia: a controlled cross-sectional study. Haemophilia. 2021 Mar;27(2):e245-e252. doi: 10.1111/hae.14240. Epub 2021 Jan 24.

    PMID: 33486846BACKGROUND
  • Poyraz Isleyen T, Tarakci E, Leblebici G, Yeldan I, Zulfikar B. Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises in Improving Balance and Gait in People With Hemophilia: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 24;14:e66770. doi: 10.2196/66770.

MeSH Terms

Conditions

Hemophilia AHemophilia BMotor Activity

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-LinkedBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 30, 2023

Study Start

November 15, 2023

Primary Completion

March 30, 2024

Study Completion

June 1, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations