Fascial Therapy in Elbow Hemophilic Arthropathy (HeL-Fascial)
Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Fascial Therapy in Hemophilic Elbow Arthropathy. A Pilot Study.
Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Secondary disorders to this joint degeneration include: biomechanical alterations, loss of range of movement and periarticular muscle atrophy.
Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of the elbow.
Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients will be recruited in 6 centers, from different regions of Spain.
Intervention: Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:
Measuring instruments and study variables: goniometric evaluation (range of movement); visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: First, it is intended to demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in the perception of elbow pain and joint mobility is expected. An improved functionality of the upper limb is also foreseen and with it, an enhanced perception of quality of life of these patients.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Madird
-
Madrid, Madird, 스페인, 28029
- Royal Victoria Eugenia Foundation
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients diagnosed with hemophilia A and B
- Patients adults (over 18 years)
- Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment with the Hemophilia Joint Health Score)
- Patients pn prophylactic treatment with FVIII / FIX concentrates.
Exclusion Criteria:
- Patients without ambulation ability
- Patients with inhibitors
- Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests
- Patients who have not signed the informed consent document.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Expermiental group
All patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates.
Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions.
Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks.
The treatment program includes 11 maneuvers that must be administered bilaterally:
|
Longitudinal surface sliding maneuver over the superficial fascia in the anterior region of the arm and the forearm. Applied in 3 strokes.
다른 이름들:
|
|
간섭 없음: Control group
Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX.
At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline elbow joint bleeding frequency after treatment and at 3 months
기간: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
After the first session of physiotherapy patients will be given a self-register where they can record all the observations they feel (from hematomas or hemarthros, to any other discomfort or perception).
Similarly, the principal investigator of the study will monitor all patients within 48 hours after each physical therapy session.
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline range of motion of elbow after treatment and at 3 months
기간: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
Change from range of movement of elbow during treatment and follow-up period at 3 months. The range of motion of the elbow joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by Felipe Querol. Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia |
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
|
Change from baseline elbow joint status after treatment and at 3 months
기간: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
Change from elbow joint status during treatment and follow-up period at 3 months.
Measurement instrument: Haemophilia Joint Health Score (scale 0-20).
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
|
Change from baseline joint pain of elbow after treatment and at 3 months
기간: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
Change from joint pain of ankle during treatment and follow-up period at 3 months.The perception of ankle pain will be measured using visual analog scale (scale 0-10).
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
|
Change from baseline upper limb functionality after treatment and at 3 months
기간: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
Change from upper limb functionality during treatment and follow-up period at 3 months.
The perception of ankle pain will be measured using DASH Questionnaire.
The Spanish version of this scale used internationally will evaluate upper limb functionality.
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
|
Change from baseline quality of life after treatment and at 3 months
기간: Screening visit, within the first seven days after treatment and after three months follow-up visit
|
Change from quality of life during treatment and follow-up period at 3 months.
The quality of life perception will be measured using SF-36 Questionnaire.
This scale will assess the perception of quality of life of patients included in the study.
|
Screening visit, within the first seven days after treatment and after three months follow-up visit
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Cuesta-Barriuso R, Meroño-Gallut J, Donoso-Úbeda E, López-Pina JA, Pérez-Llanes R. Effect of a Fascial Therapy Treatment on Quality of Life in Patients With Hemophilic Elbow Arthropathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 May;103(5):867-874. doi: 10.1016/j.apmr.2021.12.023. Epub 2022 Jan 23.
- Cuesta-Barriuso R, Perez-Llanes R, Lopez-Pina JA, Donoso-Ubeda E, Merono-Gallut J. Manual therapy reduces the frequency of clinical hemarthrosis and improves range of motion and perceived disability in patients with hemophilic elbow arthropathy. A randomized, single-blind, clinical trial. Disabil Rehabil. 2022 Jul;44(15):3938-3945. doi: 10.1080/09638288.2021.1894607. Epub 2021 Mar 8.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- HeL-Fascial
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .