Self-myofascial Release With Foam Roller in Patients With Hemophilic Knee Arthropathy

NCT ID: NCT05108480

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-26
• Study Completion Date: 2022-02-17

Brief Summary

Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscular 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. Directed: To evaluate the safety and effectiveness of a myofascial self-release protocol with Foam Roller applied in patients with hemophilic knee arthropathy.

Patients: 58 patients with knee arthropathy will be recruited for inclusion in the study. The patients will be recruited in 5 centers, from different regions of Spain.

Intervention: Each session will last approximately 15 minutes, with five physical therapy sessions per week over a period of 8 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 2 months. The treatment program includes 11 exercises to be administered bilaterally. A mobile application will be developed where each patient can observe the exercises to be performed.

Measurement instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Hemophilia Joint Health Score (Joint Condition); dynamometer evaluation (muscle strength); 6-minute walk test (lower extremity functionality); Mobile device (activity log); Finger floor test (muscle flexibility). At the same time, the study will make it possible to determine the joint bleeding caused by the applied physiotherapy treatment.

Expected results: demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, function and joint movement is expected.

Conditions

Haemophilia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-myofascial release

Each session will last approximately 15 minutes, with five physiotherapy sessions taking place over a period of 2 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: Self-Myofascial release of the plantar region using and Solid Ball Massage; Release of the myofascial components of the back of the leg using a Foam Roller; Release of the myofascial components of the anterior part of the leg using a Foam Roller; Release of myofascial components of the hamstring region using a Foam Roller; Release of the myofascial components of the adductor muscles using a Solid Ball Massage in a sitting position; Release of the myofascial components of the abductor muscles using a Foam Roller in lateral decubitus; Release of the myofascial components of the pelvitrochanterian muscles using a Foam Roller in a sitting position.

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: OTHER

This study followed the protocol designed for patients with hemophilic knee arthropathy. For its implementation, a 30-cm long15-cm diameter foam roller was used, and a ball 22 cm in length and 8 cm in diameter. The total duration of the intervention was 15 minutes, with 7 sessions per week over a period of 8 weeks. The physiotherapist who supervised the intervention followed up on all patients by telephone on a weekly basis to check for the absence of haemarthrosis during the intervention and to detect the possible need for protocol adaptations depending on the clinical situation of each patient. Each patient was individually provided with instructions as to how perform the exercises during the pretreatment evaluation, customizing the program if necessary. All patients had access to a mobile application, designed ad hoc for the research study (He-Foam®), where they could learn about the exercises through demonstration videos.

Control group

The subjects included in the control group will not receive Physiotherapy sessions and will continue with their usual routine of activity and physical exercise, and with the same drug treatment schedule with FVIII / FIX and analgesic drugs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental group

This study followed the protocol designed for patients with hemophilic knee arthropathy. For its implementation, a 30-cm long15-cm diameter foam roller was used, and a ball 22 cm in length and 8 cm in diameter. The total duration of the intervention was 15 minutes, with 7 sessions per week over a period of 8 weeks. The physiotherapist who supervised the intervention followed up on all patients by telephone on a weekly basis to check for the absence of haemarthrosis during the intervention and to detect the possible need for protocol adaptations depending on the clinical situation of each patient. Each patient was individually provided with instructions as to how perform the exercises during the pretreatment evaluation, customizing the program if necessary. All patients had access to a mobile application, designed ad hoc for the research study (He-Foam®), where they could learn about the exercises through demonstration videos.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 knee arthropathy and more than 3 points on the Hemophilia Joint Health Score.
• Being over 18 years old.
• No scheduled orthopedic surgeries during the study phase

Exclusion Criteria

• Patients with hemarthrosis in the month before the beginning of the study.
• Patients unable to walk.
• Severe functional alterations of the upper limb that prevented the exercises.
• Failure to sign the informed consent document

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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-FoamKnee

Identifier Type: -

Identifier Source: org_study_id