Hemophilia ANCT05879549
Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises Patient With Hemophilia
A study testing Closed Chain Exercise Group and Proprioceptive Exercise Group in people with Hemophilia A and Hemophilia B, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 25 years, men only
- Conditions the study is for
- Hemophilia A, Hemophilia B
- What is being tested?
- Closed Chain Exercise Group and Proprioceptive Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises in Improving Balance and Gait in Patient With Hemophilia
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?
- Conditions
- Hemophilia A, Hemophilia B
- Being tested
- Closed Chain Exercise Group, Proprioceptive Exercise Group
- Keywords
- hemophilia, exercise, balance, proprioception
- Medical subject headings
- Hemophilia A, Hemophilia B, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Chain Exercise GroupOther
Closed Chain Exercise Group
Proprioceptive Exercise GroupOther
Proprioceptive Exercise Group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Proprioceptive Exercise Group |
| Control Group | No intervention | No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
walking speed
A 10-meter walking test will be used to evaluate walking.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (3)
Single leg stance test
The Single leg stance test (SLTS) measures static balance by challenging participants to stand unassisted on 1 leg. İndividuals stand for 30 or 45 seconds with their arms crossed across their chest or with their hands touching their hips. The SLST will completed with or without shoes and using the dominant or nondominant leg.
The SLST will completed first with eyes open and then with eyes closed. Participants are timed as soon as their foot leaves the floor and stops once the foot touches the ground, the supporting foot shifts, their suspended foot touches the supporting leg, their eyes open in the eyes-closed trials, an arm is uncrossed or stops touching their hip, or if the maximum allotted time is reached.
Three trials per condition are recorded, and either an average is calculated or the longest time is used. The SLST performance is reported in seconds (continuous) and requires a stopwatch.
Measured: 12 weeks
Proprioception
A digital goniometer will be used to evaluate proprioception. The patient will be evaluated in a sitting position with eyes closed and open.
Measured: 12 weeks
2-dimensional video-based gait kinematic analysis
2-dimensional video-based gait kinematic analysis is a simple, practical and inexpensive method in which a colour camera and passive markers are used. Firstly, the fifth metatarsophalangeal joint, the lateral malleolus, the lateral femoral condyle, and the trochanter major will marked as anatomical landmarks. Thereafter, passive markers will attached with double-sided adhesive tapes on the skin. Video recordswere then obtained with a high-speed 2D video camera. The camera will located on the tripod at a distance of 1.5 m from the patient, 0.86 m above the ground and with its optical axis perpendicular to the patients' sagittal axis. The patient will be asked to walk at a normal pace in front of the camera. The 2D records will processed using the Kinovea (version .8.15, Kinovea Open Source Project), which is a free 2D motion analysis will evaluate GKP. During the phases (midstance, preswing, midswing, and late swing phases) requiring a maximal ROMin the knee and ankle joints, kinematic
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start15 Nov 2023
- Primary completion30 Mar 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Poyraz İşleyen, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879549
- Sponsor's protocol ID
- E-74555795-050.01.04-689576
- Status last verified
- Jun 2025
- First submitted
- 5 May 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33486846Poyraz 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.
PubMed 40273449
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises in Improving Balance and Gait in Patient With Hemophilia
- ClinicalTrials.gov ID
- NCT05879549
- Acronym / sponsor ID
- E-74555795-050.01.04-689576
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- hemophilia, exercise, balance, proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Closed Chain Exercise Group | Experimental | Other: Closed Chain Exercise GroupClosed kinetic chain exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks. |
| Proprioceptive Exercise Group | Experimental | Other: Proprioceptive Exercise GroupProprioceptive exercises will be given under the supervision of a physiotherapist, 2 sessions a week for 12 weeks. |
| Control Group | No intervention | –No intervention will be applied. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed Chain Exercise GroupClosed Chain Exercise Group | Other | Closed Chain Exercise Group |
| Proprioceptive Exercise GroupProprioceptive Exercise Group | Other | Proprioceptive Exercise Group |
Primary outcome
Medio-lateral and Anterior-posterior stability index
Time frame: 12 weeks
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.
walking speed
Time frame: 12 weeks
A 10-meter walking test will be used to evaluate walking.
Hemophilia joint health score
Time frame: 12 weeks
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.
3 secondary outcomes
Single leg stance test
Time frame: 12 weeks
Proprioception
Time frame: 12 weeks
2-dimensional video-based gait kinematic analysis
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 33486846Tat 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.
- Derived from this study: PubMed 40273449Poyraz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Chain Exercise Group and Proprioceptive Exercise Group in people with Hemophilia A and Hemophilia B, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medio-lateral and Anterior-posterior stability index (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05879549, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.