ACL断裂後の血流制限療法の使用
前十字靱帯断裂後の周術期リハビリテーションにおける血流制限（BFR）療法の使用
Evaluating the use of peri-operative blood flow restriction therapy surrounding anterior cruciate ligament tear
調査の概要
詳細な説明
The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy both before and after anterior cruciate ligament reconstruction (ACLR) following a tear. BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following ACL tear and reconstruction. Thus, physical therapy is used in the peri-operative period to regain strength with the ultimate goal of returning to activity.
The goal of this investigation is to determine if using BFR during perioperative therapy would lead to increased and expedited strength gains. Additionally we would like to determine if BFR helps patients to pass the standard rehabilitative functional tests and return to play sooner. We will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding ACL tear and reconstruction.
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
-
-
Michigan
-
West Bloomfield、Michigan、アメリカ、48332
- Henry Ford Hospital
-
-
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:
- ACL tear undergoing reconstruction
Exclusion Criteria:
- History of pulmonary embolism
- History of deep vein thrombosis
- Family history of PE/DVT
- Hypercoaguable disorder
- Multiligamentous knee injury
- Neurovascular injury
- Peripheral vascular disease
- Unable to complete physical therapy
- Unable to tolerate blood flow restriction
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：BFR Treatment
Patients will be recruited following ACL tear and medical screening for history of DVT/PE. Patients allocated to the BFR intervention group will undergo physical therapy with the use of a blood flow restriction cuff. Rehabilitation will consist of a structured home exercise program prior to surgery. We will instruct patients on how to perform home BFR and test them in the office to ensure competence. Following surgery patients will immediately be started in physical therapy. Therapy will consist of a structured program progressing from range of motion, to strength training and then functional tests. Both arms will use the same protocol with the only difference being use of BFR. |
Blood flow restriction cuffs will be used as an augment to physical therapy |
|
介入なし：Control
The control arm will undergo the same pre and post operative physical therapy as the BFR group. They will undergo a structure home therapy program prior to surgery and an outpatient physical therapy program under the guidance of a therapist following surgery. |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quadriceps Strength in the Operative Leg
時間枠：Change from Initial Clinic Visit to Pre-op
|
Quadriceps strength via handheld dynamometer. Quadriceps torque generation of operative leg evaluated at Initial Clinic Visit (ICV) and Pre-op (surgery scheduled 2 weeks after ICV) |
Change from Initial Clinic Visit to Pre-op
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Reported Outcome Measurement Information System
時間枠：Initial Clinic Visit
|
Patient reported outcomes measurement information system score on patient physical function. PROMIS-PF: Assesses Activities of Daily Living and Capabilities. Below 30: Severe limitations, 30-40: Moderate limitations, 40-45: Mild limitations, Above 50: Greater than average physical function. Score scale (0-100) PROMIS-PI: Assesses Pain Indication. Below 55: Within normal limits of pain interference, 50-59: Mild interference, 60-69: Moderate interference, Above 70: Severe pain interference. Score scale (0-100) PROMIS-D: Measures Depressive symptoms: Below 55: Normal to slight symptoms, 55-59: Mild symptoms, 60-69: Moderate symptoms, Above 70: Severe depressive symptoms. Score scale (0-100) |
Initial Clinic Visit
|
|
Participants Reporting Pain Using the Visual Analog Scale
時間枠：Three months
|
Visual analog scale pain scores, scale 0-10 higher is more pain |
Three months
|
|
Quadricep Strength in Non-operated Leg
時間枠：Change from Initial Clinic Visit to Pre-Op
|
Quadriceps torque generation of non-operative leg evaluated at Initial Clinic Visit (ICV) and Pre-op (surgery scheduled 2 weeks after ICV) |
Change from Initial Clinic Visit to Pre-Op
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。