Haemophilic ArthropathyNCT06438406
Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy
A study testing Orthotic devices and therapeutic exercise (Group A) and Orthotic devices (Group B) in people with Haemophilic Arthropathy and Orthosis, run by University of Palermo at 1 site in Italy.
Trial summary
Haemophilic arthropathy (HA) is the most frequent complication of haemophilia and is often associated with a severe deterioration in quality of life. It is caused by repeated joint bleeding resulting in chronic proliferative synovitis and progressive destruction of articular cartilage. Read more about this study
- Who is it for?
- Ages 6 to 50 years, men only
- Conditions the study is for
- Haemophilic Arthropathy, Orthosis, Foot Malalignment
- What is being tested?
- Orthotic devices and therapeutic exercise (Group A) and Orthotic devices (Group B)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2023to 27 May 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 6 to 50 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of severe haemophilia A or B;
- age ≥ 6 years and ≤ 50 years;
- presence of hindfoot and/or arch misalignment;
- prophylaxis with factor deficient (VIII or IX).
Who cannot join
- patients with prosthetic implants/synthetic means
- uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Haemophilic arthropathy (HA) is the most frequent complication of haemophilia and is often associated with a severe deterioration in quality of life. It is caused by repeated joint bleeding resulting in chronic proliferative synovitis and progressive destruction of articular cartilage. The most frequently affected joints are the knees, ankles and elbows.
The aim of this study is to verify the use of lower limb orthoses in combination with postural rehabilitation, assessing the incidence of spontaneous haemarthroses and haematomas as the primary endpoint and pain and QoL as secondary endpoints.
Read more
We conducted a prospective observational, randomised and controlled study on outpatients attending the UOC of Recovery and Functional Rehabilitation of the AOUP Paolo Giaccone of Palermo for haemophilic arthropathy sent by the UO of Haematology of the same hospital. The study period was between January 2017 and March 2023.
The patients recruited were randomly divided into two groups by means of a computer-generated random number system: group A, consisting of patients who were prescribed orthoses and a 20-session rehabilitation programme; group B, consisting of patients who were only prescribed orthoses for the lower limbs. The rehabilitation programme was based on the Back School method.
All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2).
Two arthropathic-specific scales were used to assess outcomes, namely the Hemophilia Joint Health Score (HJHS), which reflects joint function and status, and the Functional Independence Score in Hemophilia (FISH), which relates to the patient\'s quality of life. We also used the Numerical Rating Scale (NRS) for joint pain. Finally, postural assessment was performed in static posture, observing the patient\'s alignment in different planes and using the APECS (AI Posture Evaluation and Correction System ®) mobile app. During the re-evaluations, any new haemarthroses and haematomas were also assessed.
- Conditions
- Haemophilic Arthropathy, Orthosis, Foot Malalignment
- Being tested
- Orthotic devices and therapeutic exercise (Group A), Orthotic devices (Group B)
- Keywords
- haemophilic arthropathy, orthosis, postural assestment, foot malalignment, therapeutic exercise, haemarthroses, haematomas, HJHS, FISH
- Medical subject headings
- Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthotic devices and therapeutic exercise (Group A)Device
Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method
Orthotic devices (Group B)Device
Group B consisting of patients who were only prescribed orthoses for the lower limbs
| Study group | Role | What they receive |
|---|---|---|
| Orthotic devices and therapeutic exercise (Group A) | Active comparator | Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method Receives: Device: Orthotic devices and therapeutic exercise (Group A); Device: Orthotic devices (Group B) |
| Orthotic devices (Group B) | Active comparator | Group B consisting of patients who were only prescribed orthoses for the lower limbs Receives: Device: Orthotic devices and therapeutic exercise (Group A); Device: Orthotic devices (Group B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of haemophilic arthropathy
During re-evaluations, the possible appearance of new haemarthroses and haematomas was assessed ,which were absent at the baseline examination
Measured: All patients were assessed at 3 months (T1) and after 6 months (T2).
Secondary outcomes (3)
Functional Independence Score in Hemophilia (FISH)
This score is a performance-based assessment tool used to measure the functional ability of patients. The maximum score is 32 (the greatest autonomy).
Measured: All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
Hemophilia Joint Health Score (HJHS)
The Hemophilia Joint Health Score is a rating scale that measures joint health in the domains of anatomical structure and function (biomechanics) of the joints most frequently affected by haemorrhage in haemophilia: knees, ankles, elbows.
Measured: All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
Numerical Rating Scale (NRS)
The NRS scale is a one-dimensional 11-point scale that assesses pain intensity in adults, with a range from 0 to 10, corresponding to 'no pain' and 'worst pain imaginable'
Measured: All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Apr 2023
- Primary completion30 Oct 2023
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438406
- Sponsor's protocol ID
- MFR052024
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Assessment, Therapeutic Exercise and Orthotic Devices in the Prevention of Haemophilic Arthropathy
- ClinicalTrials.gov ID
- NCT06438406
- Acronym / sponsor ID
- MFR052024
- Conditions
- Haemophilic Arthropathy, Orthosis, Foot Malalignment
- Keywords
- haemophilic arthropathy, orthosis, postural assestment, foot malalignment, therapeutic exercise, haemarthroses, haematomas, HJHS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 31 May 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.
Haemophilic arthropathy (HA) is the most frequent complication of haemophilia and is often associated with a severe deterioration in quality of life. It is caused by repeated joint bleeding resulting in chronic proliferative synovitis and progressive destruction of articular cartilage. The most frequently affected joints are the knees, ankles and elbows.
The aim of this study is to verify the use of lower limb orthoses in combination with postural rehabilitation, assessing the incidence of spontaneous haemarthroses and haematomas as the primary endpoint and pain and QoL as secondary endpoints.
We conducted a prospective observational, randomised and controlled study on outpatients attending the UOC of Recovery and Functional Rehabilitation of the AOUP Paolo Giaccone of Palermo for haemophilic arthropathy sent by the UO of Haematology of the same hospital. The study period was between January 2017 and March 2023.
The patients recruited were randomly divided into two groups by means of a computer-generated random number system: group A, consisting of patients who were prescribed orthoses and a 20-session rehabilitation programme; group B, consisting of patients who were only prescribed orthoses for the lower limbs. The rehabilitation programme was based on the Back School method.
All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2).
Two arthropathic-specific scales were used to assess outcomes, namely the Hemophilia Joint Health Score (HJHS), which reflects joint function and status, and the Functional Independence Score in Hemophilia (FISH), which relates to the patient\'s quality of life. We also used the Numerical Rating Scale (NRS) for joint pain. Finally, postural assessment was performed in static posture, observing the patient\'s alignment in different planes and using the APECS (AI Posture Evaluation and Correction System ®) mobile app. During the re-evaluations, any new haemarthroses and haematomas were also assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthotic devices and therapeutic exercise (Group A) | Active comparator | Device: Orthotic devices and therapeutic exercise (Group A), Device: Orthotic devices (Group B)Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method |
| Orthotic devices (Group B) | Active comparator | Device: Orthotic devices and therapeutic exercise (Group A), Device: Orthotic devices (Group B)Group B consisting of patients who were only prescribed orthoses for the lower limbs |
Who may qualify
- Ages
- 6 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- diagnosis of severe haemophilia A or B;
- age ≥ 6 years and ≤ 50 years;
- presence of hindfoot and/or arch misalignment;
- prophylaxis with factor deficient (VIII or IX).
Key exclusion criteria (2 listed)
- patients with prosthetic implants/synthetic means
- uncooperative patients
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 |
|---|---|---|
| Orthotic devices and therapeutic exercise (Group A)Group A consisting of patients who were prescribed orthoses, to use gradually, and a 20-session rehabilitation programme, based on the Back School method | Device | Orthotic devices (Group B), Orthotic devices and therapeutic exercise (Group A) |
| Orthotic devices (Group B)Group B consisting of patients who were only prescribed orthoses for the lower limbs | Device | Orthotic devices (Group B), Orthotic devices and therapeutic exercise (Group A) |
Primary outcome
prevention of haemophilic arthropathy
Time frame: All patients were assessed at 3 months (T1) and after 6 months (T2).
During re-evaluations, the possible appearance of new haemarthroses and haematomas was assessed ,which were absent at the baseline examination
3 secondary outcomes
Functional Independence Score in Hemophilia (FISH)
Time frame: All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
Hemophilia Joint Health Score (HJHS)
Time frame: All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
Numerical Rating Scale (NRS)
Time frame: All patients were assessed at baseline (T0), at 3 months (T1) and after 6 months (T2)
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 31 May 2024.
- Individual participant dataSharing planned: Yes
Related trials for Haemophilic Arthropathy
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Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
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Real-World Joint Outcomes After Selective Transition to Low-Dose Emicizumab in Pediatric Hemophilia A
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Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy
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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 Orthotic devices and therapeutic exercise (Group A) and Orthotic devices (Group B) in people with Haemophilic Arthropathy and Orthosis, run by University of Palermo at 1 site in Italy.
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 4 inclusion and 2 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 31 May 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 Italy. 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?
prevention of haemophilic arthropathy (time frame: All patients were assessed at 3 months (T1) and after 6 months (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2024.