- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03230942
Effect of Pre-op Patient Education on Functional Outcomes After TKA
Effect of Pre-operative Patient Education Program on Functional Outcomes After Total Knee Arthroplasty
연구 개요
상세 설명
The study will be developed in the dependencies of the Laboratory of Biomechanics of the Center for Health Sciences and Sports of UDESC. In the preoperative period the subjects will be informed about their physical conditions as well as signs and symptoms of the postoperative period. One group (GI) will receive this information verbally and one leaflet while the other group (GC) will receive only verbal information. The allocation in these groups will be through a lottery, carried out by a member of the team who will not participate in the evaluation stages.
This staff member will read the booklet individually for each GI participant, in a reserved room, before handing out the leaflet to take home. GI participants will be encouraged to reread the information in the home environment and will be asked about the completion of this in the following steps by the staff member responsible for the blinding.
All participants included in the study will perform the kinematic, kinetic and electromyographic gait analysis as well as evaluation of fear of movement, functional mobility and self-perceived functionality in the pre (baseline)-and postoperative period (6 weeks and after 6 months).
The total duration of each evaluation will be approximately 2 (two) hours and 30 (thirty) minutes and all collections will be carried out by the same team. The participant will be allowed to stop the test if they feel pain or become fatigued.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Santa Catarina
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Florianópolis, Santa Catarina, 브라질, 88080350
- Center for Health and Sport Sciences
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Literate;
- Elective submission of unilateral total knee arthroplasty (TKA) due to osteoarthrosis
- Individuals without other arthroplasties in the lower limb in the last 6 months;
- Range of motion greater than 90 degrees or operated contralateral knee.
Exclusion Criteria:
- Associated condition that impedes performance in gait tests, including significant osteoarthrosis in the contralateral knee or hips (defined as pain greater than or equal to 5 on the analog visual pain scale);
- Absence or abandonment in the study follow-up sessions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Patient education program
Pre-operative education and pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
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Verbal and booklet about symptoms and physical conditions pos knee replacement
다른 이름들:
Physical therapy treatment
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활성 비교기: Control - only pos-op rehabilitation
Pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
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Physical therapy treatment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Timed up And Go Test score
기간: pre-operative; 6 weeks; 6 months
|
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
The TUG has good inter-rater and intra-rater reliability and validity for functional testing in older adults at risk for falls.
The test is easy to administer and can be completed in two to three minutes.Change from baseline (pre-operative) in the functional mobility.
The variable will be measured in seconds.
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pre-operative; 6 weeks; 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
EMG activity
기간: pre-operative; 6 weeks; 6 months
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Electromyographic activity of rectus femoris, vastus lateralis, vastus medialis, vastus medial and gastrocnemius by NORAXON WIRELESS EMG.
Change from baseline (pre-operative).The variable will be measured in % of maximal voluntary contraction.
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pre-operative; 6 weeks; 6 months
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Kinematics
기간: pre-operative; 6 weeks; 6 months
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Gait analysis by VICON three-dimensional ,10-camera motion capture system.The outcome measurement is assessed at pre-operation, six weeks and six month after operation.
Change from baseline (pre-operative).
The variable will be measured in degrees.
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pre-operative; 6 weeks; 6 months
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Kinetics
기간: pre-operative; 6 weeks; 6 months
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Gait analysis by AMTI plate force.
The outcome measurement is assessed at pre-operation, six weeks and six month after operation.
Change from baseline (pre-operative).
The variable will be measured in newtons
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pre-operative; 6 weeks; 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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kinesiophobia
기간: pre-operative; 6 weeks; 6 months
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Fear of movement.
The variable will be measured in points (score).
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pre-operative; 6 weeks; 6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gilmar M Santos, PhD, University of State of Santa Catarina
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. .
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