- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07655271
Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery
연구 개요
상세 설명
This study is designed as a master's thesis and will be conducted as an observational, cross-sectional, assessment-based study. The study will be carried out at the Department of Physiotherapy and Rehabilitation, Biruni University. Ethical approval has been obtained from the Biruni University Scientific Research Ethics Committee. The study will be conducted in accordance with the principles of the Declaration of Helsinki, and written informed consent will be obtained from all participants before participation.
The study will include adults with obstetric brachial plexus palsy who underwent shoulder tendon transfer surgery using the Modified Hoffer technique during childhood and healthy age-matched individuals. Individuals with obstetric brachial plexus palsy who have had at least five years since surgery will be included. Participants will be recruited on a voluntary basis among individuals referred by physicians, followed clinically, or admitted to the Department of Physiotherapy and Rehabilitation at Biruni University. All assessments will be performed by the same researcher in the Patient Assessment Laboratory of the Department of Physiotherapy and Rehabilitation.
The primary outcome of the study is pain. Pain intensity will be assessed using the Numeric Rating Scale. Secondary outcomes will include upper extremity range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance. Shoulder and forearm range of motion will be assessed for flexion, abduction, external rotation, internal rotation, supination, and pronation using the Kinvent K-Move Digital Goniometer. Muscle strength will be assessed using the MicroFET-2 digital handheld dynamometer for the relevant primary muscle groups of the shoulder and forearm.
Functional status will be evaluated using the Shoulder Pain and Disability Index and the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. Social appearance anxiety will be assessed using the Social Appearance Anxiety Scale. Role performance and perceived activity performance will be evaluated using the Canadian Occupational Performance Measure.
To ensure methodological consistency between the obstetric brachial plexus palsy group and the healthy control group, the same standardized assessment battery will be applied to both groups. Physical and functional upper extremity measurements will be recorded bilaterally to allow comparison between the affected and unaffected sides in individuals with obstetric brachial plexus palsy and between the dominant and non-dominant sides in healthy controls.
The study aims to describe the clinical profile of adults with obstetric brachial plexus palsy after Modified Hoffer tendon transfer and to compare their pain, upper extremity function, range of motion, muscle strength, psychosocial status, and role performance with those of healthy peers.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34015
- 모병
- Biruni University
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연락하다:
- Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
- 전화번호: +905392870087
- 이메일: fahrib@biruni.edu.tr
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연락하다:
- Zeynep Hosbay, Physiotherapist, Prof.
- 전화번호: +905055034279
- 이메일: zhosbay@biruni.edu.tr
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수석 연구원:
- Zeynep Hosbay, Physiotherapist, Prof.
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부수사관:
- Fahri Dogukan Bozkurt, Physiotherapist, MSc Student
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부수사관:
- Gulsena Utku Umut, Physiotherapist, PhD
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부수사관:
- Busra Ulker Eksi, Physiotherapist, PhD
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부수사관:
- Hayri Omer Berkoz, MD, Assoc. Prof.
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부수사관:
- Atakan Aydin, MD, Prof.
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion and Exclusion Criteria
Inclusion Criteria for Individuals With Brachial Plexus Birth Palsy:
- Being between 18 and 40 years of age.
- Having a diagnosis of unilateral brachial plexus birth palsy.
- Having undergone shoulder tendon transfer surgery using the Modified Hoffer Technique.
- Having at least 5 years elapsed since the last surgery.
- Having a cognitive and communication level sufficient to comply with the assessment process.
- Agreeing to participate voluntarily in the study and signing the informed consent form.
Inclusion Criteria for Healthy Individuals:
- Being between 18 and 40 years of age.
- Having no history of upper extremity-related surgery within the last 5 years.
- Having a cognitive and communication level sufficient to comply with the assessment process.
- Agreeing to participate voluntarily in the study and signing the informed consent form.
Exclusion Criteria for All Participants:
- Having a neurological disease.
- Having another orthopedic problem or a history of trauma in the affected upper extremity.
- Having a history of systemic disease requiring an acute attack or hospitalization within the last 3 months.
- Pregnancy or being less than 6 months postpartum.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Adults With Brachial Plexus Birth Palsy
Adults with obstetric brachial plexus palsy who underwent shoulder tendon transfer surgery using the Modified Hoffer technique during childhood.
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Participants will undergo a standardized clinical assessment including pain, range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance measures.
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Healthy Controls
Healthy age-matched individuals without obstetric brachial plexus palsy.
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Participants will undergo a standardized clinical assessment including pain, range of motion, muscle strength, functional status, social appearance anxiety, and role/activity performance measures.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Intensity at Rest, During Activity, and at Night
기간: Baseline
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Pain intensity will be assessed using the Numeric Rating Scale under three conditions: pain at rest, pain during activity, and pain at night.
Participants will rate their pain from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
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Baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Upper Extremity Range of Motion
기간: Baseline
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Upper extremity range of motion will be assessed using the Kinvent K-Move Digital Goniometer.
Shoulder flexion, shoulder extension, shoulder abduction, shoulder external rotation, shoulder internal rotation, elbow flexion, elbow extension, forearm supination, forearm pronation, wrist flexion, and wrist extension will be measured bilaterally.
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Baseline
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Upper Extremity Muscle Strength
기간: Baseline
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Upper extremity muscle strength will be assessed using the MicroFET-2 digital handheld dynamometer.
The relevant primary muscle groups of the shoulder, elbow, forearm, and wrist will be measured bilaterally.
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Baseline
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Shoulder Pain and Disability
기간: Baseline
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Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index.
Higher scores indicate greater shoulder pain and disability.
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Baseline
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Upper Extremity Disability
기간: Baseline
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Upper extremity disability will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire.
Higher scores indicate greater upper extremity disability.
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Baseline
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Social Appearance Anxiety
기간: Baseline
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Social appearance anxiety will be assessed using the Social Appearance Anxiety Scale.
Higher scores indicate greater social appearance anxiety.
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Baseline
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Role and Activity Performance
기간: Baseline
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Role and activity performance will be assessed using the Canadian Occupational Performance Measure.
Importance, performance, and satisfaction scores will be recorded based on participant-identified activities.
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Baseline
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024-BİAEK/19-40
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
상완 신경총 마비에 대한 임상 시험
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Malatya Egitim Ve Arastirma Hastanesi완전한Perfusion Index 및 Pleth Variability Index는 Brachial Plexus Block 성공의 초기 지표입니다. 무작위 임상 시험칠면조
Clinical Assessment Battery에 대한 임상 시험
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Beth Israel Deaconess Medical CenterBrigham and Women's Hospital; Clinical Innovations, LLC종료됨
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Vanderbilt University Medical Center모집하지 않고 적극적으로
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Queen Elizabeth Hospital, Hong Kong완전한
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Centre for Addiction and Mental HealthUniversity Health Network, Toronto완전한
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Oslo University HospitalThe Research Council of Norway완전한림프종 | 백혈병 | 암 | 줄기세포 이식
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Memorial Sloan Kettering Cancer Center종료됨
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Tan Tock Seng HospitalMarquette University; Lee Kong Chian School of Medicine, Nanyang Technological University아직 모집하지 않음
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University of NottinghamEnhanced Recovery After Surgery Group (part of ESPEN)완전한