- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07668531
Kinesiophobia and Functional Outcomes in Distal Radius Fractures
Time-Dependent Changes in Kinesiophobia and Functional Outcomes in Conservatively Treated Distal Radius Fractures
Distal radius fractures are among the most common fractures in adults and are frequently treated with closed reduction and cast immobilization. Although fracture healing is generally successful, some patients may develop fear of movement (kinesiophobia) after cast removal because of pain, reinjury concerns, or reduced confidence in using the injured wrist.
The purpose of this study is to evaluate the level of kinesiophobia in adults with conservatively treated distal radius fractures and to investigate how kinesiophobia changes over time following cast removal. The study will also examine the relationship between kinesiophobia and functional recovery.
Participants will be assessed after cast removal and again at three months following injury. Kinesiophobia, pain intensity, hand and wrist function, range of motion, grip strength, and upper extremity disability will be evaluated using standardized assessment tools. The findings may help clinicians better understand the role of movement-related fear in recovery and support the development of rehabilitation strategies aimed at improving functional outcomes after distal radius fractures.
연구 개요
상세 설명
Distal radius fractures are among the most frequently encountered upper-extremity fractures in adults and are commonly managed using conservative treatment methods, including closed reduction and cast immobilization. While successful bone healing is generally achieved, prolonged immobilization may contribute to pain, stiffness, reduced confidence in movement, and the development of kinesiophobia (fear of movement).
Kinesiophobia has been recognized as an important psychological factor that may negatively influence rehabilitation outcomes in various musculoskeletal conditions. Increased fear of movement may result in activity avoidance, delayed return to daily activities, reduced use of the affected extremity, and persistent disability. Recent studies have demonstrated associations between kinesiophobia and upper-limb functional limitations following wrist and hand injuries; however, evidence regarding the temporal evolution of kinesiophobia after conservatively treated distal radius fractures remains limited.
The primary objective of this prospective observational clinical study is to evaluate changes in kinesiophobia over time in adults with conservatively treated distal radius fractures. The secondary objective is to investigate the relationship between kinesiophobia and functional outcomes during the recovery process.
Patients aged 18-65 years with AO type A distal radius fractures treated with closed reduction and short-arm cast immobilization will be recruited from the Orthopedics and Traumatology Clinic of Marmara University Pendik Training and Research Hospital. All participants will receive standard conservative treatment. The cast will be removed at approximately five weeks after injury.
The first assessment will be performed three days after cast removal. Kinesiophobia will be evaluated using the Tampa Scale for Kinesiophobia (TSK), and pain intensity will be recorded using a Visual Analog Scale (VAS). A second assessment will be conducted at the third month following injury. At this time, kinesiophobia will be reassessed using the TSK. Functional status will be evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Hand and wrist function, grip strength, and relevant clinical parameters will also be assessed.
Inclusion criteria include adults aged 18-65 years with AO type A distal radius fractures treated conservatively with closed reduction and short-arm cast immobilization and without treatment-related complications. Exclusion criteria include previous fracture or neurological disorders affecting the same upper extremity, concomitant injuries involving the wrist, elbow, or shoulder, cognitive impairment, severe psychiatric disorders, and surgically treated distal radius fractures.
No experimental intervention, additional imaging procedure, or investigational medication will be used. All participants will provide written informed consent prior to enrollment. The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki.
The results of this study are expected to improve understanding of the role of kinesiophobia in recovery after distal radius fractures and may contribute to the development of rehabilitation programs targeting psychological as well as physical aspects of recovery.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Samir İlgaroğlu, Surgeon
- 전화번호: +905536166156
- 이메일: doktorsamir.zeynal@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age range: 18-65 years
- Non-intra-articular extension (AO type A) distal radius fracture
- Treatment with closed reduction and short arm cast
- No complications during treatment (redisplacement, fracture failure, etc.)
- Ability to cooperate and complete the questionnaire
Exclusion Criteria:
- History of previous fracture or neurological pathology in the same extremity
- Associated wrist, elbow, or shoulder injury
- Cognitive impairment or serious psychiatric illness
- Surgically treated distal radius fractures
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 |
|---|---|
|
실험적: Female Participants
Female adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization.
|
Standard conservative management consisting of closed reduction followed by short-arm cast immobilization for the treatment of distal radius fractures.
|
|
실험적: Male Participants
Male adults aged 18-65 years with conservatively treated distal radius fractures who undergo prospective assessment of kinesiophobia and functional outcomes following cast immobilization.
|
Standard conservative management consisting of closed reduction followed by short-arm cast immobilization for the treatment of distal radius fractures.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Kinesiophobia Level
기간: Week 5 (3 days after cast removal) and Month 3
|
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK).
Changes in TSK scores between the assessment performed 3 days after cast removal (approximately week 5) and the assessment performed at month 3 will be evaluated.
|
Week 5 (3 days after cast removal) and Month 3
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Upper Extremity Disability
기간: Month 3
|
Upper extremity disability and symptoms will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
|
Month 3
|
|
Pain Intensity
기간: Week 5 and Month 3
|
Pain intensity will be assessed using a Visual Analog Scale (VAS).
|
Week 5 and Month 3
|
|
Grip Strength
기간: Month 3
|
Hand grip strength will be measured using a hand dynamometer and recorded in kilograms (kg).
|
Month 3
|
|
Wrist Range of Motion
기간: Month 3
|
Wrist flexion, extension, radial deviation, and ulnar deviation will be measured using a goniometer and recorded in degrees.
|
Month 3
|
공동 작업자 및 조사자
간행물 및 유용한 링크
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 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. .