- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03113149
Strongest Predictors of a Positive Outcome After Physiotherapy for Knee Osteoarthritis
Which Factors Are the Strongest Predictors of a Positive Outcome After Physiotherapy for Patients With Knee Osteoarthritis?
Individuals with painful knee osteoarthritis (OA) experience restricted physical function. Few previous studies have investigated comprehensive sets of constructs and tests to investigate physical function in these patients. Most single studies of knee OA patients show limited scope for explaining physical function in the perspective of WHO's International Classification of Functioning, Disability and Health (ICF) 3 levels: Body functions (the bodily level), Activities (individual level), and Participation (societal level). On the bodily level there is limited case-control knowledge on muscle strength beyond the knee and endurance-strength in general. On the activity level, there is similar limitation of biomechanical bodily features in stair climbing. On the participation level the situation is similar for objective performance. Measures are needed that inter-relate all three levels of ICF. These should also include well discriminating tests e.g. knee strength, walking, and activities of daily life (ADL), as well as both objective and subjective measures.
The purpose of this study is to explore mechanisms that can explain physical function in patients with knee OA in primary care. The study's main and primary goal is to quantify which baseline factors and change scores are the strongest predictors of a positive treatment outcome in terms of patients' global perceived change after physiotherapy. Secondary research question is: which factors are the strongest predictors of a positive outcome of physiotherapy in knee OA, in terms of pain intensity, patient specific functional scale, and function in daily living?
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Trondheim, 노르웨이
- Department of Neuromedicine and Movement Science, NTNU
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Clinical and radiological osteoarthritis of the knee and referred to physiotherapists.
- Symptomatic daily during the last month.
- Symptomatic for more than one year.
- Able to walk up and down a flight of 10 stairs with or without walking aids.
- Able to walk 3 stairs up and down without walking aids.
- Understand Norwegian orally and in writing.
- Body mass index below 35.
Exclusion Criteria:
- Neurological, rheumatic, orthopedic, or respiratory diagnosis, other than osteoarthritis of the knee which can negatively affect the walking ability, balance or pain.
- Body mass index above or equal to 35.
- Fracture of the femur or shank, or arthroscopic surgery in the osteoarthritic knee.
- Chronic generalized pain (American College of Rheumatology Criteria, 2010).
- Inability to understand Norwegian language.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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knee osteoarthritis
Patients with knee osteoarthritis after having started physical therapy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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patient global perceived effect
기간: Change from baseline 'patient global perceived effect' at 3 months
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patient global perceived effect scale (Dworkin 2005, Evans 2014)
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Change from baseline 'patient global perceived effect' at 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient Specific Functional Scale
기간: Change from baseline 'Patient Specific Functional Scale' at 3 months
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Patient Specific Functional Scale (Stratford, 1995)
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Change from baseline 'Patient Specific Functional Scale' at 3 months
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Pain intensity
기간: Change from baseline 'Pain intensity' at 3 months
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Pain Intensity scale (Dworkin 2005)
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Change from baseline 'Pain intensity' at 3 months
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Function of daily living
기간: Change from baseline 'Function of daily living' at 3 months
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Function of daily living scale (KOOS) (Roos & Lohmander 2003)
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Change from baseline 'Function of daily living' at 3 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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. .