NCT06816056 Manual Therapy in Hemophilic Arthropathy of the Ankle
| NCT ID | NCT06816056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Investigación en Hemofilia y Fisioterapia |
| Condition | Hemophilia A |
| Study Type | INTERVENTIONAL |
| Enrollment | 13 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2025-07-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 13 participants in total. It began in 2025-02-05 with a primary completion date of 2025-07-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: Haemophilic ankle arthropathy manifests as functional (deficit in muscle strength, mobility and proprioception), intra-articular degenerative alterations and chronic pain. Manual therapy techniques are characterised by treating the soft tissues with the aim of modifying their density, relieving pain, reducing tissue sensitivity and improving the ranges of mobility. The objective is to evaluate the safety and effectiveness of a manual therapy protocol in patients with haemophilic ankle arthropathy. Methods: Randomised crossover clinical trial. 13 patients with haemophilic ankle arthropathy from different regions of Spain will be recruited and randomised into two study groups (experimental and control). Each session of the experimental group will last 50 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 4 weeks. The treatment programme includes 10 techniques that must be administered bilaterally. The study variables are the frequency of ankle haemarthrosis, range of movement, pressure pain threshold, pain intensity, joint status, biomechanical analysis of gait and balance, functionality and kinesiophobia. Expected results: To evaluate the safety of manual therapy in patients with haemophilia. To observe changes in pain, mobility, joint condition, stability and functionality of the ankle, and kinesiophobia.
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with haemophilia A and B * With severe haemophilia phenotype (\<1% FVIII/FIX) * Over 18 years of age * With a medical diagnosis of ankle arthropathy and with clinical assessment using the Hemophilia Joint Health Score * On prophylactic or on-demand treatment with coagulation factor VIII/FIX concentrates Exclusion Criteria: * Patients with neurological or cognitive disorders that prevent them from understanding the questionnaires and physical tests * Failure to sign the informed consent document
Contact & Investigator
Rubén Cuesta-Barriuso, PhD
PRINCIPAL INVESTIGATOR
Universidad de Oviedo
Frequently Asked Questions
Who can join the NCT06816056 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 65 Years, studying Hemophilia A. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06816056 currently recruiting?
Yes, NCT06816056 is actively recruiting participants. Contact the research team at cuestaruben@uniovi.es for enrollment information.
Where is the NCT06816056 trial being conducted?
This trial is being conducted at Murcia, Spain.
Who is sponsoring the NCT06816056 clinical trial?
NCT06816056 is sponsored by Investigación en Hemofilia y Fisioterapia. The principal investigator is Rubén Cuesta-Barriuso, PhD at Universidad de Oviedo. The trial plans to enroll 13 participants.