Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?
Does Early Mobilisation After Surgical Repair of Rotator Cuff Tears Improve Biomechanical and Clinical Outcomes?
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Lancashire
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Wigan、Lancashire、イギリス、WN6 9EP
- Wrightington Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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
|
アクティブコンパレータ: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Change from baseline range of motion
時間枠: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
|
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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change from baseline muscle activity in millivolts
時間枠: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
|
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
|
Re-tears ratio
時間枠:1 year
|
1 year
|
協力者と研究者
捜査官
- 主任研究者:Jim Richards, Professor、University of Central Lancashire
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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