Self-myofascial Release in Hemophilic Ankle Arthropathy

NCT05104164 | Completed

• 1 other identifier: He-FoamAnk
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia

Keywords

Hemophilic arthropathy; Ankle; Self-myofascial release; Safety; Joint pain; Functionality

Outcome Measures

Primary Outcomes (1)

• Change from baseline ankle bleeding after treatment and at 3 months

  The safety of the intervention was evaluated through periodic monitoring of the development of ankle hemarthrosis. The physiotherapist in charge of evaluating the patients performed weekly follow-up telephone calls during the experimental phase to evaluate the development of ankle hemarthrosis or other complications (bruising). Bleeding-related data were collected by the evaluator after the follow-up period.

  Screening visit, within the first seven days after treatment and after three months follow-up visit

Secondary Outcomes (3)

• Change from baseline ankle pain after treatment and at 3 months

  Screening visit, within the first seven days after treatment and after three months follow-up visit

• Change from baseline range of ankle motion after treatment and at 3 months

  Screening visit, within the first seven days after treatment and after three months follow-up visit

• Change from baseline functional capacity after treatment and at 3 months

  Screening visit, within the first seven days after treatment and after three months follow-up visit

Study Arms (1)

Self-myofascial release

EXPERIMENTAL

Each session will last approximately 15 minutes, with five physiotherapy sessions taking place over a period of 3 months. The Self-Myofascial release protocol for the lower limbs using a Foam Roller and and Solid Ball Massage, adapted to patients with hemophilic ankle arthropathy will include 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.

Other: Self-myofascial release

Interventions

Self-myofascial release OTHER

At home, the patients performed a daily session, lasting 15 minutes each, over 8 weeks. Patients accessed an ad hoc mobile application designed by the Hemophilia Physiotherapy research group (He-Foam®). This app, accessible from any smartphone, made it possible to watch the videos with all the exercises included in the intervention. The seven exercises under the specific protocol for patients with hemophilic arthropathy were: Self-release of the plantar region of the foot with a foam ball; Release of the posterior region of the leg with the foam roller; Release of the anterior leg region with a foam roller; Release of the hamstrings region with a foam roller; Release of adductor muscles with a foam ball; Release of abductor muscles with a foam roller; Release of pelvic trochanteric muscles with a foam roller

Self-myofascial release

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being over 18 years old
• Patients with a medical diagnosis of hemophilia A or B.
• Patients with a severe phenotype of hemophilia (\<1% FVIII/FIX).
• Patients with a medical diagnosis of hemophilic ankle arthropathy and more than 3 points on the Hemophilia Joint Health Score.
• Nno scheduled orthopedic surgeries during the study phase.
• Signing the informed consent document.

You may not qualify if:

• Patients with ankle hemarthrosis in the month before the beginning of the study.
• Patients unable to walk even with technical aids.
• Patients with hemophilic elbow arthropathy that prevented the performance of the exercises.
• Patients failing to complete at least 80% of the sessions scheduled in the intervention

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

University of Murcia

Murcia, 30006, Spain

Location

MeSH Terms

Conditions

Hemophilia A; Arthralgia

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The physiotherapist in charge of the evaluations was blinded to the conditions and study objectives.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 2, 2021
• Study Start: September 2, 2020
• Primary Completion: November 27, 2020
• Study Completion: December 30, 2020
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)