- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02631486
Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?
Does Early Mobilisation After Surgical Repair of Rotator Cuff Tears Improve Biomechanical and Clinical Outcomes?
연구 개요
상세 설명
The study will be a randomised controlled trial, which means that each participant will have equal chances to be assigned to one of 2 groups.
The first group will start the rehabilitation after 3 weeks post-surgery and the second group will start after 6 weeks.
The rehabilitation stages will start with passive movements, progressing to more active stages phases until full recovery. The whole program will last about 3 months, which is in accordance to what is normally used at the Wrightington Hospital.
Each participant will have 4 assessment sessions: 1 pre-surgery, after 3 months post-surgery, after 6 months and the last after 12 months post-surgery.
The assessment sessions will consist on answering questionnaires and a clinical assessment with equipment, which measures muscle activity and joint angles during clinical tasks.
An ultrasound scan of the shoulder to assess the integrity of the rotator cuff would be carried out one year after surgery by a consultant radiologist.
These assessments are timed with the routine orthopaedic clinic assessments so that patients do not have to make extra trips to take part in the research.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Lancashire
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Wigan, Lancashire, 영국, WN6 9EP
- Wrightington Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age between 40 and 70 years old,
- Confirmed diagnosis of rotator cuff tear
- No previous shoulder surgery
- No other musculoskeletal impairment in the assessed limb or cervical and thoracic spine.
Exclusion Criteria:
- Previous shoulder surgery
- Fixation which does not allow early mobilisation
- Other musculoskeletal impairment in the assessed limb or cervical and thoracic spine,
- People with special needs who are unable to understand the instructions needed,
- Non-English or non-Portuguese speakers.
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: Early
The first group will use sling for comfort only. Active assisted exercises in closed chain and in safe zone are allowed in the first 4 weeks. The rehabilitation stages will start from active assisted progressing to more active stages phases until full recovery. The whole program will last about 3 months. |
Passive exercises, active exercises, strengthening, stretching
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활성 비교기: Conservative
The second group will use a sling for 6 weeks.
The rehabilitation stages will start with active assisted/closed chain movements with short levers, it will progress to more active stages phases until full recovery.
The whole program will last about 3 months.
|
Passive exercises, active exercises, strengthening, stretching
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change from baseline range of motion
기간: Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
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Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline muscle activity in millivolts
기간: Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
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The muscle activity will be measured using non-invasive electromyography
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Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
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Re-tears ratio
기간: 1 year
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jim Richards, Professor, University of Central Lancashire
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .