Hemophilia ArthropathyNCT06331091
Physiotherapy and Reaction Time in Hemophilia
A study testing Home exercise, Manual therapy and Neuromuscular electrical stimulation in people with Hemophilia Arthropathy, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Read more about this study
- Who is it for?
- Ages 10 to 32 years, men only
- Conditions the study is for
- Hemophilia Arthropathy
- What is being tested?
- Home exercise, Manual therapy and Neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2022to 19 Jan 2024
- 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 10 to 32 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- -Clinical diagnosis of hemophilic arthropathy in ankle and/or
Who cannot join
- Clinical diagnosis of any neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Low Frequency Comprehensive Physiotherapy Combined With Home Exercise on Joint Health, Frequency of Hemartrosis, Dynamic Balance and Reaction Time in Hemophilic Arthropthy
This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Is physiotherapy combined with home exercises superior to home exercises on joint health, bleeding frequency, reaction time, dynamic balance, muscle strength? The aim of this study is to increase the compliance of hemophilic individuals to physiotherapy and adapt home exercises to their lives with weekly sessions.
Read the detailed description
Introduction: The positive effects of physiotherapy and exercise on joint health, frequency of hemartrosis (FoH) in patient with hemophilic arhropathy (PwHA) are well explained in the literature. However, adaptation problems to physiotherapy sessions (usually 3 times a week) may cause PwHA to ignore the need for therapy. It may be more beneficial for PwHA to adapt physiotherapy and exercise into daily live.
Aim: To investigate the effect of a once-a-week physiotherapy combined with home exercises on joint health, FoH, muscle strength, pain, reaction time and dynamic balance.
Methods: 20 patients have hemophilic arthropathy in knee and/or ankle were randomly divided into 2 groups, named home exercise (HE) and comprehensive physiotherapy combined with home exercise (CPcwHE). In the clinical assessment, HJHS, manuel muscle tester, Fitlight® system for reaction time, functional reach test for dynamic balance were used and questioned the number of bleedings in the last 6 weeks for FoH. The CP group received comprehensive physiotherapy (manual therapy, neuromuscular electrical stimulation and exercises) 1 day a week, and did the exercises at home the other 2 days a week. The HE group performed the exercises given to CP at home 3 times a week. Evaluations were repeated at the end of 6 weeks.
- Conditions
- Hemophilia Arthropathy
- Being tested
- Home exercise, Manual therapy, Neuromuscular electrical stimulation, Supervised exercise
- Keywords
- hemophilia, physiotherapy, exercise, reaction time, joint health, arthropathy
- Medical subject headings
- Hemophilia A, Motor Activity, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exerciseOther
Home exercise are done at home without the supervision of a specialist.
Manual therapyOther
Manual therapy is special techniques for soft tissues and joints applied by a physiotherapist.
Neuromuscular electrical stimulationDevice
Home exercise are done at home without the supervision of a specialist. Manual therapy is special techniques for soft tissues and joints applied by a physiotherapist.
Neuromuscular electrical stimulation is the application of electrical current to the muscle through special electrodes in order to increase muscle strength.
Supervised exercise is done under the supervision of a physiotherapist.
Supervised exerciseOther
Supervised exercise is done under the supervision of a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise | Active comparator | This group performed the same exercises given to comprehensive physiotherapy group at home 3 times a week for 6 weeks. Receives: Other: Home exercise |
| Comprehensive physiotherapy | Experimental | This group received comprehensive physiotherapy (manual therapy, neuromuscular electrical stimulation and exercises) 1 day a week, and did the exercises at home the other 2 days a week for 6 weeks. Receives: Other: Home exercise; Other: Manual therapy; Device: Neuromuscular electrical stimulation; Other: Supervised exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemophilia Joint Health Score
Joint health (Max values= 84, min values=0. As the value increases, joint health worsens.)
Measured: 6 weeks
Reaction time
Dynamic balance
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start10 Dec 2022
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophilia ArthropathyStudies 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
- Model description
- Randomised controlled study
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Merve TAT, Yuzuncu Yil University
- Investigators
- Ayse Merve Tat, Asst. Prof., Study chair, Van Yüzüncü Yıl University, Faculty of Health ScienceNecati Muhammed Tat, Principal investigator, Van Yüzüncü Yıl University, Faculty of Health ScienceSerbay Şekeröz, Asst. Prof., Principal investigator, Van Yüzüncü Yıl University, Faculty of Health ScienceMeryem M Büke, Asst. Prof., Principal investigator, Van Yüzüncü Yıl University, Faculty of Health ScienceKamuran M Karaman, Prof., Study chair, Van Yüzüncü Yıl University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331091
- Sponsor's protocol ID
- YuzuncuYıl2022/2
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol and Statistical Analysis Plan
Publications
Tat AM, Tat NM, Sekeroz S, Buke M, Karaman K. Low frequency physiotherapy on joint health, hemarthrosis, walking, balance and reaction time in hemophilic arthropathy: a controlled trial. BMC Musculoskelet Disord. 2025 Apr 4;26(1):332. doi: 10.1186/s12891-025-08549-4.
PubMed 40186132
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Low Frequency Comprehensive Physiotherapy Combined With Home Exercise on Joint Health, Frequency of Hemartrosis, Dynamic Balance and Reaction Time in Hemophilic Arthropthy
- ClinicalTrials.gov ID
- NCT06331091
- Acronym / sponsor ID
- YuzuncuYıl2022/2
- Conditions
- Hemophilia Arthropathy
- Keywords
- hemophilia, physiotherapy, exercise, reaction time, joint health, arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 26 Mar 2024 (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.
This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Is physiotherapy combined with home exercises superior to home exercises on joint health, bleeding frequency, reaction time, dynamic balance, muscle strength? The aim of this study is to increase the compliance of hemophilic individuals to physiotherapy and adapt home exercises to their lives with weekly sessions.
Detailed description
Introduction: The positive effects of physiotherapy and exercise on joint health, frequency of hemartrosis (FoH) in patient with hemophilic arhropathy (PwHA) are well explained in the literature. However, adaptation problems to physiotherapy sessions (usually 3 times a week) may cause PwHA to ignore the need for therapy. It may be more beneficial for PwHA to adapt physiotherapy and exercise into daily live.
Aim: To investigate the effect of a once-a-week physiotherapy combined with home exercises on joint health, FoH, muscle strength, pain, reaction time and dynamic balance.
Methods: 20 patients have hemophilic arthropathy in knee and/or ankle were randomly divided into 2 groups, named home exercise (HE) and comprehensive physiotherapy combined with home exercise (CPcwHE). In the clinical assessment, HJHS, manuel muscle tester, Fitlight® system for reaction time, functional reach test for dynamic balance were used and questioned the number of bleedings in the last 6 weeks for FoH. The CP group received comprehensive physiotherapy (manual therapy, neuromuscular electrical stimulation and exercises) 1 day a week, and did the exercises at home the other 2 days a week. The HE group performed the exercises given to CP at home 3 times a week. Evaluations were repeated at the end of 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Home exercise | Active comparator | Other: Home exerciseThis group performed the same exercises given to comprehensive physiotherapy group at home 3 times a week for 6 weeks. |
| Comprehensive physiotherapy | Experimental | Other: Home exercise, Other: Manual therapy, Device: Neuromuscular electrical stimulation, Other: Supervised exerciseThis group received comprehensive physiotherapy (manual therapy, neuromuscular electrical stimulation and exercises) 1 day a week, and did the exercises at home the other 2 days a week for 6 weeks. |
Who may qualify
- Ages
- 10 to 32 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -Clinical diagnosis of hemophilic arthropathy in ankle and/or
Key exclusion criteria (1 listed)
- Clinical diagnosis of any neurological disease
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 |
|---|---|---|
| Home exerciseHome exercise are done at home without the supervision of a specialist. | Other | Comprehensive physiotherapy, Home exercise |
| Manual therapyManual therapy is special techniques for soft tissues and joints applied by a physiotherapist. | Other | Comprehensive physiotherapy |
| Neuromuscular electrical stimulationHome exercise are done at home without the supervision of a specialist. Manual therapy is special techniques for soft tissues and joints applied by a physiotherapist. Neuromuscular electrical stimulation is the application of electrical current to the muscle through special electrodes in order to increase muscle strength. Supervised exercise is done under the supervision of a physiotherapist. | Device | Comprehensive physiotherapy |
| Supervised exerciseSupervised exercise is done under the supervision of a physiotherapist. | Other | Comprehensive physiotherapy |
Primary outcome
Hemophilia Joint Health Score
Time frame: 6 weeks
Joint health (Max values= 84, min values=0. As the value increases, joint health worsens.)
Reaction time
Time frame: 6 week
Dynamic balance
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 2 Apr 2024.
- Derived from this study: PubMed 40186132Tat AM, Tat NM, Sekeroz S, Buke M, Karaman K. Low frequency physiotherapy on joint health, hemarthrosis, walking, balance and reaction time in hemophilic arthropathy: a controlled trial. BMC Musculoskelet Disord. 2025 Apr 4;26(1):332. doi: 10.1186/s12891-025-08549-4.
- Individual participant dataSharing planned: No. Study Protocol and Statistical Analysis Plan
Related trials for Hemophilia Arthropathy
Enrolling by invitation
3D Ultrasound in Hemophilic Ankles
Hemophilia
Recruiting
Identification of New Biomarkers in Haemophilic Arthropathy Through Transcriptome Analysis
Hemophilia A and B
Not yet recruiting
Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
Hemophilic Arthropathy, Chronic Pain
Active, not recruitingObservational study
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
Hemophilia A
Not yet recruiting
Ultrasound Assessment of Joint Health in Patients With Mild Hemophilia (Factor Levels 5-40%)
Mild Hemophilia
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.
Ayse Merve Tat, Asst. Prof. study chair
Van Yüzüncü Yıl University, Faculty of Health Science
Necati Muhammed Tat principal investigator
Van Yüzüncü Yıl University, Faculty of Health Science
Serbay Şekeröz, Asst. Prof. principal investigator
Van Yüzüncü Yıl University, Faculty of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise, Manual therapy and Neuromuscular electrical stimulation in people with Hemophilia Arthropathy, run by Yuzuncu Yil 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 1 inclusion and 1 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 2 Apr 2024. 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?
Hemophilia Joint Health Score (time frame: 6 weeks). The study lists 2 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 NCT06331091, which also lists 1 linked publication.
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 2 Apr 2024.