NCT05039008Completed
Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy
Effectiveness of Physiotherapy Intervention by Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy. Randomized Multicenter Clinical Study.
Source: ClinicalTrials.gov · Last updated 9 Feb 2024
Brief summary (registry, in English)
Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy. Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in the perception of muscle activation and strength, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle. Study design. Randomized, multicenter, single-blind clinical study. Method. 20patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 3 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and range of motion (goniometer). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks. Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength, joint pain, range of motion, and joint damage in patients with hemophilic knee and ankle arthropathy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 1 Sept 2021
- Start date
- 6 Sept 2023
- Primary completion date
- 14 Nov 2023
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Diseases
- Haemophilia
- NCT number
- NCT05039008
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From 6 Sept 2023 to the primary completion date, 14 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are receiving Physiotherapy treatment at the time of the study
Other illness
- Patients with neurological or cognitive disorders that impede understanding of the test.
Other
- Pain free patients
- Amputees, epileptics or patients with severe vision problems
- Patients who have not signed the informed consent document
Who the study is looking for
- Patients diagnosed with hemophilia A and B
- Patients with a medical diagnosis of hemophilic ankle and knee arthropathy
- People over 18 years of age
- Patients on prophylactic or on-demand treatment regimen with FVIII / FIX concentrates
Age in the registry: 18 years to 65 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rubén Cuesta-Barriuso Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.