NCT05108480

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

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 Knee Arthropathy: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Investigación en Hemofilia y Fisioterapia · Network
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-10-26
• Primary completion: 2022-02-17
• Completion: 2022-02-17
• First posted: 2021-11-05
• Last updated: 2022-03-03

Locations

1 site across 1 country: Spain