Clinical trial NCT03914287: Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy
Official title: Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Self-myofascial Release With Foam Roller in Patients With Hemophilic Ankle Arthropathy. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2019-04-16
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.

Design. A randomized clinical trial. Aimed: To evaluate the safety and effectiveness of a protocol by self-myofascial release with Foam Roller applied in patients with hemophilic ankle arthropathy.

Patients: 70 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in 5 centers, from different regions of Spain.

Intervention: Each session will last approximately 15 minutes, with five physiotherapy sessions per week for a period of 3 months. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 months. The treatment program includes 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out.

Measuring instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Haemophilia Joint Health Score (joint status); dynamometer assess (muscle strength); 6-Minute Walking test (functionality of lower limbs); Mobile device (Activity record); Finger-floor test (muscle flexibility). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.

Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, functionality and joint motion is expected.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hemophilia A and B disease.
* Over 18 years.
* Diagnosed with hemophilic arthropathy of the ankle (by clinical assessment with the Hemophilia Joint Health Score).
* On prophylactic or on demand treatment with FVIII / FIX concentrates.

Exclusion Criteria:

* Patients without ambulation ability.
* Patients with inhibitors (antibodies to FVIII or FIX).
* Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests.
* Not signed the informed consent document.

Primary outcomes:
measure: Change from baseline ankle joint pain after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Secondary outcomes:
measure: Change from baseline ankle joint pain after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline lower limb functionality after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline range of motion of ankle after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline muscle strength after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline muscle flexibility after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea de Madrid
state: Comunity Of Madrid
Study officials:
affiliation: Real Fundación Victoria Eugenia
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merono-Gallut AJ, Cuesta-Barriuso R, Perez-Llanes R, Donoso-Ubeda E, Lopez-Pina JA. Self-Myofascial Release Intervention and Mobile App in Patients With Hemophilic Ankle Arthropathy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 31;9(7):e15612. doi: 10.2196/15612.