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

NCT03914287 | Completed

• 1 other identifier: He-Foam
• Study Type: interventional
• Target: 58
• 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

Outcome Measures

Primary Outcomes (1)

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

  Visual analogic scale (VAS). This scale will be used to evaluate the perception of joint pain, where ankle joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).

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

Secondary Outcomes (5)

• Change from baseline ankle joint 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 lower limb functionality 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 motion of ankle 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 muscle strength 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 muscle flexibility after treatment and at 3 months

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

Study Arms (2)

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

Control

NO INTERVENTION

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.

Interventions

Self-Myofascial release 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.

Self-myofascial release

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

Related Publications (1)

• 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.

  PMID: 32734929 DERIVED

MeSH Terms

Conditions

Hemophilia A

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

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Real Fundación Victoria Eugenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: February 2, 2020
• Primary Completion: June 26, 2020
• Study Completion: December 15, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)