Self-myofascial Release in Hemophilic Ankle Arthropathy

NCT ID: NCT05104164

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2020-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-myofascial release

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.

Group Type: EXPERIMENTAL

Self-myofascial release

Intervention Type: 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

Interventions

Self-myofascial release

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Investigación en Hemofilia y Fisioterapia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Murcia

Locations

University of Murcia

Murcia, , Spain

Countries

Spain

Other Identifiers

He-FoamAnk

Identifier Type: -

Identifier Source: org_study_id