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

NCT ID: NCT03914287

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-02
• Study Completion Date: 2020-12-15

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

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 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

The Self-Myofascial release protocol for the lower limbs using a Foam Roller 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; and release of the myofascial components of the pelvitrochanteric muscles using a Foam Roller in a sitting position.

Control

Patients included in the control group will not receive any physiotherapy intervention. They will continue with their routine prior to the beginning of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self-Myofascial release

The Self-Myofascial release protocol for the lower limbs using a Foam Roller 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; and release of the myofascial components of the pelvitrochanteric muscles using a Foam Roller in a sitting position.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Investigación en Hemofilia y Fisioterapia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Real Fundación Victoria Eugenia

Locations

Universidad Europea de Madrid

Madrid, Comunity of Madrid, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 32734929 (View on PubMed)

Other Identifiers

He-Foam

Identifier Type: -

Identifier Source: org_study_id