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Self-myofascial Release in Hemophilic Ankle Arthropathy

Primary Purpose

Hemophilia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Self-myofascial release
Sponsored by
Investigación en Hemofilia y Fisioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia focused on measuring Hemophilic arthropathy, Ankle, Self-myofascial release, Safety, Joint pain, Functionality

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Murcia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-myofascial release

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline ankle bleeding after treatment and at 3 months
The safety of the intervention was evaluated through periodic monitoring of the development of ankle hemarthrosis. The physiotherapist in charge of evaluating the patients performed weekly follow-up telephone calls during the experimental phase to evaluate the development of ankle hemarthrosis or other complications (bruising). Bleeding-related data were collected by the evaluator after the follow-up period.

Secondary Outcome Measures

Change from baseline ankle pain after treatment and at 3 months
The intensity of joint pain was assessed using the visual analog scale (VAS). This scale rates ankle joint pain with scores from zero to 10 points (from no pain to the maximum perceived pain).
Change from baseline range of ankle motion after treatment and at 3 months
The range of ankle motion in dorsal and plantar flexion was measured with a universal goniometer, with one-degree increments. The patient was placed in a supine position, with the axis of the goniometer on the lateral malleolus and the fixed arm of the goniometer parallel to the fibula. This procedure was accompanied by verbal stimulus to the patient to control the compensatory movement of the toes and the range of movement of the talocrural joint. The unit of measurement is the degrees (the higher the mark, the better the range of motion).
Change from baseline functional capacity after treatment and at 3 months
Functional capacity was measured with the 6-Minute Walk test, using the standardization described by the American Thoracic Society. The test was performed on a flat, hard, straight, 20-m long surface. Before the test, the evaluator instructed each patient to walk the track twice to familiarize themselves with the test and warm up. The evaluating physiotherapist used standardized verbal stimuli during the test with all subjects. Patients were asked to walk at a constant speed, without jumping or running, for 6 minutes. To measure the exact distance walked during the test the physiotherapist closely followed the patients with a stopwatch.

Full Information

First Posted
October 25, 2021
Last Updated
October 25, 2021
Sponsor
Investigación en Hemofilia y Fisioterapia
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1. Study Identification

Unique Protocol Identification Number
NCT05104164
Brief Title
Self-myofascial Release in Hemophilic Ankle Arthropathy
Official Title
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 Ankle Arthropathy. A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Investigación en Hemofilia y Fisioterapia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia
Keywords
Hemophilic arthropathy, Ankle, Self-myofascial release, Safety, Joint pain, Functionality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The physiotherapist in charge of the evaluations was blinded to the conditions and study objectives.
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-myofascial release
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Self-myofascial release
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline ankle bleeding after treatment and at 3 months
Description
The safety of the intervention was evaluated through periodic monitoring of the development of ankle hemarthrosis. The physiotherapist in charge of evaluating the patients performed weekly follow-up telephone calls during the experimental phase to evaluate the development of ankle hemarthrosis or other complications (bruising). Bleeding-related data were collected by the evaluator after the follow-up period.
Time Frame
Screening visit, within the first seven days after treatment and after three months follow-up visit
Secondary Outcome Measure Information:
Title
Change from baseline ankle pain after treatment and at 3 months
Description
The intensity of joint pain was assessed using the visual analog scale (VAS). This scale rates ankle joint pain with scores from zero to 10 points (from no pain to the maximum perceived pain).
Time Frame
Screening visit, within the first seven days after treatment and after three months follow-up visit
Title
Change from baseline range of ankle motion after treatment and at 3 months
Description
The range of ankle motion in dorsal and plantar flexion was measured with a universal goniometer, with one-degree increments. The patient was placed in a supine position, with the axis of the goniometer on the lateral malleolus and the fixed arm of the goniometer parallel to the fibula. This procedure was accompanied by verbal stimulus to the patient to control the compensatory movement of the toes and the range of movement of the talocrural joint. The unit of measurement is the degrees (the higher the mark, the better the range of motion).
Time Frame
Screening visit, within the first seven days after treatment and after three months follow-up visit
Title
Change from baseline functional capacity after treatment and at 3 months
Description
Functional capacity was measured with the 6-Minute Walk test, using the standardization described by the American Thoracic Society. The test was performed on a flat, hard, straight, 20-m long surface. Before the test, the evaluator instructed each patient to walk the track twice to familiarize themselves with the test and warm up. The evaluating physiotherapist used standardized verbal stimuli during the test with all subjects. Patients were asked to walk at a constant speed, without jumping or running, for 6 minutes. To measure the exact distance walked during the test the physiotherapist closely followed the patients with a stopwatch.
Time Frame
Screening visit, within the first seven days after treatment and after three months follow-up visit

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Cuesta-Barriuso, PhD
Organizational Affiliation
Universidad de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Murcia
City
Murcia
ZIP/Postal Code
30006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-myofascial Release in Hemophilic Ankle Arthropathy

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