HaemophiliaNCT05425888
Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy
An observational study of Haemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations (muscle strength deficit, mobility and proprioception), intra-articular and chronic pain. Design: Case-control study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Haemophilia
- What is being tested?
- Hemophilia group
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2022to 23 Dec 2022
- Phase
- Observational
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Patients with hemophilic ankle arthropathy older than 18 years (group of cases). Healthy subjects without ankle joint damage, of the same age range (control groups).
Who may be able to join
- Patients diagnosed with hemophilia A and B.
- Over 18 years.
- With medical diagnosis of ankle arthropathy.
- With clinical evaluation by Hemophilia Joint Health Score.
- In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
- No previous hemarthrosis of the ankles in the 3 months prior to evaluation.
Who cannot join
- Patients with inhibitors (antibodies against FVIII or FIX).
- Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests.
- Failure to sign the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy. A Case-control Study
Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations (muscle strength deficit, mobility and proprioception), intra-articular and chronic pain.
Design: Case-control study. Objective: To observe the differences between patients with hemophilic ankle arthropathy and their healthy peers, regarding dorsiflexion, dorsiflexion strength, biomechanical analysis of gait and balance, and functionality.
Read more
Patients: 10 patients with hemophilic ankle arthropathy and 12 healthy subjects without ankle joint damage.
Measurement instruments and study variables: dorsiflexion (range of motion), dorsiflexion strength (dynamometry), biomechanical analysis of gait and balance (RS SCAN® model platform), and functionality (2 Minute Walk Test).
Expected results: Analyze the main differences and their relationship based on the clinical and independent variables of patients with hemophilia, compared to their healthy peers.
- Conditions
- Haemophilia
- Being tested
- Hemophilia group
- Keywords
- Hemophilic arthropathy, Ankle, Joint pain, Functionality, Range of motion, Proprioception
- Medical subject headings
- Hemophilia A, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemophilia groupOther
Evaluation of the study variables: dorsal flexion; dorsiflexion strength; tibialis anterior muscle activation; biomechanical analysis of gait and balance; and functionality.
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia group | Group of adult patients with hemophilia, diagnosed with bilateral hemophilic ankle arthropathy Receives: Other: Hemophilia group | |
| Control group | Group of healthy subjects with sociodemographic characteristics similar to patients with hemophilia, diagnosed with bilateral hemophilic ankle arthropathy. Receives: Other: Hemophilia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the dorsal flexion with numerical scale of range of motion
Measurement with Leg Motion system. Subjects will stand with the big toe on the starting line and the knee touching a metal stick. The metal rod will move away from the foot up to the maximum ankle dorsiflexion allowed, without taking the heel off the ground and with knee contact on the rod. Three measurements will be made for each ankle and the mean value will be used for data analysis. All measurements will be made with the patient barefoot.
Measured: Screening visit
Assess the dorsiflexion strength with dynamometry
The maximal isometric strength of the ankle flexor muscles will be tested. Both extremities will be evaluated with a manual dynamometer (model Lafayette Manual Muscle Tester 01165). The examiner will hold the dynamometer on the sole of the foot while the subject exerts maximal force against it. The unit of measurement of this measurement instrument is the Newton per square centimeter (N/cm2), where the higher the score, the greater the muscle force.
Measured: Screening visit
Secondary outcomes (2)
Assess the biomechanical analysis of gait and balance with pressure platform
It will be evaluated using an Rs Scan® pressure platform and FootScan® pressure measurement system. This scientific version biomechanical examination device measures plantar pressure using an X-Y array of resistive pressure sensitive sensors that are scanned sequentially. The system records pressure data when the subject is standing or walking on the platform. Measurements will be made with the basic 0.5m platform with 4,096 sensors with resistive technology and 300Hz data acquisition frequency. The biomechanics of walking will be analyzed with the analysis of the probes and the static balance in a time of 30 seconds
Measured: Screening visit
Assess the functionality with pressure platform
The 2-Minute Walking Test will be used. The functional capacity to exercise, in clinical practice, will be evaluated by means of a modified version, used in populations with pathologies with special characteristics, of the 6-minute version. It will be carried out in a closed corridor, with a length of 30 m delimited between cones. Before the test, participants must rest for at least 10 minutes. Subsequently, they will be instructed to complete the circuit by walking around the cones as fast as possible, but without running, for 2 minutes. They will be allowed to use walking aids, slow down or stop to rest if necessary. The distance covered at the end of the 2 minutes will be recorded by the evaluator. This instrument has shown excellent test-retest reliability.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start22 Jun 2022
- Primary completion18 Nov 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Collaborators
- Real Fundación Victoria Eugenia
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, University of Oviedo
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425888
- Sponsor's protocol ID
- He-AnkleCon
- Status last verified
- Feb 2024
- First submitted
- 10 Jun 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Proprioceptive Status in Patients With Hemophilic Ankle Arthropathy. A Case-control Study
- ClinicalTrials.gov ID
- NCT05425888
- Acronym / sponsor ID
- He-AnkleCon
- Conditions
- Haemophilia
- Keywords
- Hemophilic arthropathy, Ankle, Joint pain, Functionality, Range of motion, Proprioception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Collaborators
- Real Fundación Victoria Eugenia
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 21 Jun 2022 (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.
Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations (muscle strength deficit, mobility and proprioception), intra-articular and chronic pain.
Design: Case-control study. Objective: To observe the differences between patients with hemophilic ankle arthropathy and their healthy peers, regarding dorsiflexion, dorsiflexion strength, biomechanical analysis of gait and balance, and functionality.
Patients: 10 patients with hemophilic ankle arthropathy and 12 healthy subjects without ankle joint damage.
Measurement instruments and study variables: dorsiflexion (range of motion), dorsiflexion strength (dynamometry), biomechanical analysis of gait and balance (RS SCAN® model platform), and functionality (2 Minute Walk Test).
Expected results: Analyze the main differences and their relationship based on the clinical and independent variables of patients with hemophilia, compared to their healthy peers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemophilia group | – | Other: Hemophilia groupGroup of adult patients with hemophilia, diagnosed with bilateral hemophilic ankle arthropathy |
| Control group | – | Other: Hemophilia groupGroup of healthy subjects with sociodemographic characteristics similar to patients with hemophilia, diagnosed with bilateral hemophilic ankle arthropathy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with hemophilic ankle arthropathy older than 18 years (group of cases). Healthy subjects without ankle joint damage, of the same age range (control groups).
Key inclusion criteria (6 listed)
- Patients diagnosed with hemophilia A and B.
- Over 18 years.
- With medical diagnosis of ankle arthropathy.
- With clinical evaluation by Hemophilia Joint Health Score.
- In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
Key exclusion criteria (3 listed)
- Patients with inhibitors (antibodies against FVIII or FIX).
- Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests.
- Failure to sign the informed consent document
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 |
|---|---|---|
| Hemophilia groupEvaluation of the study variables: dorsal flexion; dorsiflexion strength; tibialis anterior muscle activation; biomechanical analysis of gait and balance; and functionality. | Other | Control group, Hemophilia group |
Primary outcome
Assess the dorsal flexion with numerical scale of range of motion
Time frame: Screening visit
Measurement with Leg Motion system. Subjects will stand with the big toe on the starting line and the knee touching a metal stick. The metal rod will move away from the foot up to the maximum ankle dorsiflexion allowed, without taking the heel off the ground and with knee contact on the rod. Three measurements will be made for each ankle and the mean value will be used for data analysis. All measurements will be made with the patient barefoot.
Assess the dorsiflexion strength with dynamometry
Time frame: Screening visit
The maximal isometric strength of the ankle flexor muscles will be tested. Both extremities will be evaluated with a manual dynamometer (model Lafayette Manual Muscle Tester 01165). The examiner will hold the dynamometer on the sole of the foot while the subject exerts maximal force against it. The unit of measurement of this measurement instrument is the Newton per square centimeter (N/cm2), where the higher the score, the greater the muscle force.
2 secondary outcomes
Assess the biomechanical analysis of gait and balance with pressure platform
Time frame: Screening visit
Assess the functionality with pressure platform
Time frame: Screening visit
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 9 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
University of Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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 3 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 9 Feb 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 Spain. 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?
Assess the dorsal flexion with numerical scale of range of motion (time frame: Screening visit). 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?
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 9 Feb 2024.