- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07697495
Scapulothoracic Stabilization and Postural Training in Upper Extremity Lymphedema
Effects of Scapulothoracic Stabilization and Postural Training Added to Standard Lymphedema Care on Muscle Strength, Posture and Functional Outcomes in Secondary Upper Extremity Lymphedema: A Single-Center Randomized Controlled Trial
연구 개요
상태
정황
상세 설명
Secondary upper extremity lymphedema is a common complication following breast cancer treatment and is characterized by chronic swelling, pain, reduced muscle strength, impaired upper extremity function, and postural alterations. These impairments may negatively affect daily activities, body perception, and quality of life. Although Complex Decongestive Therapy (CDT) is considered the gold standard for lymphedema management, conventional treatment primarily focuses on edema reduction and does not specifically address scapular stability, postural alignment, or neuromuscular control.
Altered scapulothoracic biomechanics and postural dysfunction are frequently observed in individuals with breast cancer-related lymphedema. These impairments may contribute to shoulder dysfunction, muscle weakness, compensatory movement patterns, and persistent functional limitations. Scapulothoracic stabilization exercises aim to restore scapular muscle balance and improve dynamic shoulder stability, whereas postural training promotes optimal alignment and body awareness. The combined application of these interventions may enhance functional recovery beyond the effects of standard CDT alone; however, evidence from randomized controlled trials remains limited.
This single-center, prospective, randomized controlled trial aims to evaluate the effectiveness of adding scapulothoracic stabilization and postural training to standard lymphedema care in women with secondary upper extremity lymphedema following breast cancer surgery. Participants will be randomly allocated to either a control group receiving standard lymphedema care or an intervention group receiving standard care plus scapulothoracic stabilization and postural training. Randomization will be performed using a computer-generated allocation sequence, and all outcome assessments will be conducted by a blinded assessor.
Outcome measures will be collected at baseline, immediately after completion of treatment, and at a 2-month follow-up. Primary and secondary outcomes will include scapular muscle strength measured with a handheld dynamometer (MicroFET2), postural alignment assessed using the PostureScreen application, upper extremity function evaluated with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, limb volume calculated from serial circumference measurements, and neck awareness assessed using the Fremantle Neck Awareness Questionnaire (FreNAQ). The findings of this study are expected to provide evidence regarding the clinical benefits of incorporating targeted scapulothoracic stabilization and postural training into conventional lymphedema rehabilitation and may contribute to the development of more comprehensive rehabilitation protocols for breast cancer survivors.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: İdil Esin Ünlü, Assist. Prof. Dr.
- 전화번호: +90 506 515 66 22
- 이메일: idil.unlu@toros.edu.tr
연구 장소
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Adana, 터키 (Türkiye)
- 모병
- Adana Şehir Eğitim ve Araştırma Hastanesi
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연락하다:
- Deniz TUNCA, PT
- 전화번호: +90 532 409 36 33
- 이메일: denizcanoglu82@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Female patients aged 18 to 65 years.
- Diagnosed with secondary upper extremity lymphedema following breast cancer surgery (mastectomy).
- Willing to participate in the study.
- Able to provide written informed consent.
Exclusion Criteria:
- Active infection (e.g., cellulitis or lymphangitis).
- Advanced shoulder or cervical pathology.
- Neurological disorders affecting upper extremity function.
- Metastatic disease.
- Receiving active chemotherapy.
- Participation in another intensive lymphedema rehabilitation program within the previous 3 months.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Scapulothoracic Stabilization
Participants assigned to the experimental group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with a structured scapulothoracic stabilization and postural training program.
The additional exercise program is designed to improve scapular muscle function, postural alignment, and upper extremity function.
Assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
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Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises.
Treatment will be delivered according to established clinical guidelines and routine lymphedema rehabilitation protocols.
A supervised exercise program consisting of scapulothoracic stabilization exercises and postural training designed to improve scapular muscle strength, postural alignment, and upper extremity function.
The program will be provided in addition to standard Complex Decongestive Therapy throughout the treatment period.
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활성 비교기: Control
Participants assigned to the control group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises according to routine clinical practice.
Outcome assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
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Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises.
Treatment will be delivered according to established clinical guidelines and routine lymphedema rehabilitation protocols.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Upper Extremity Function
기간: Baseline, immediately after completion of treatment, and 2 months after treatment
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Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
The DASH is a validated 30-item patient-reported outcome measure evaluating symptoms and functional limitations of the upper extremity.
Scores range from 0 to 100, with higher scores indicating greater disability.
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Baseline, immediately after completion of treatment, and 2 months after treatment
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Change in Head Anterior Translation
기간: Baseline, immediately after completion of treatment, and 2 months after treatment
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Head anterior translation will be assessed using the PostureScreen mobile application.
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Baseline, immediately after completion of treatment, and 2 months after treatment
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Change in Shoulder Height Asymmetry
기간: Baseline, immediately after completion of treatment, and 2 months after treatment.
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Shoulder height asymmetry will be assessed using the PostureScreen mobile application.
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Baseline, immediately after completion of treatment, and 2 months after treatment.
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Change in Shoulder Anterior Translation
기간: Baseline, immediately after completion of treatment, and 2 months after treatment.
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Shoulder anterior translation will be assessed using the PostureScreen mobile application.
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Baseline, immediately after completion of treatment, and 2 months after treatment.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Scapular Muscle Strength
기간: Baseline, immediately after completion of treatment, and 2 months after treatment
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Scapular muscle strength (upper, middle, and lower trapezius muscles) will be measured using a handheld dynamometer (MicroFET2) with the isometric make-test method.
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Baseline, immediately after completion of treatment, and 2 months after treatment
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 25.02.2026-1214/23
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
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