Comparative Effectiveness of Blood Flow Restriction With or Without Total Motion Release in ACL Rehabilitation (BFR-TMR-ACL)
Effects of Blood Flow Restriction With or Without Total Motion Release on Strength, Balance and Functional Disability in Postoperative ACL Injury
The aim of this clinical trial is to compare the effectiveness of combined Blood Flow Restriction (BFR) and Total Motion Release (TMR) versus BFR alone in the restoration of muscular strength, balance and knee functionality in men and women aged 16 to 45 years who have undergone primary unilateral ACL reconstruction.
The major research questions that it seeks to address are:
Does the addition of TMR to a BFR protocol lead to significantly higher improvements in absolute quadriceps strength and subjective knee functioning as measured by IKDC scores? Does the combined protocol lead to better functional balance and symmetry in terms of the Single Leg Stance (SLS) test and Limb Symmetry Index (LSI)? The researchers will compare the BFR + TMR group to the BFR-only group to determine whether the integrated approach speeds up functional recovery and alleviates neuromuscular control deficits more effectively than strength-focused training alone.
Participant TasksParticipants will: Undergo 3 sessions/week of supervised rehabilitation over a 6 month period. Complete Blood Flow Restriction (BFR) training consisting of low-load exercises (mini squats and knee extensions) with an inflatable cuff placed around the proximal part of the thigh at 60-80% occlusion pressure. Should there be in the experimental group, Total Motion Release (TMR) exercises (e.g., trunk rotations and hip shifts) on the contralateral side (i.e. non-painful side) to correct movement asymmetries before the BFR training. Baseline, 6 weeks, 12 weeks, and 6 months of complete subjective self-assessments (IKDC forms) and objective physical tests (dynamometer strength testing and single-leg balance tests).
調査の概要
詳細な説明
Evaluate and compare the effectiveness of Blood Flow Restriction (BFR) therapy as a single intervention against a combined protocol of Blood Flow Restriction and Total Motion Release (BFR+TMR) in men and women aged 16-45 who had undergone primary unilateral ACL reconstruction. The study aimed to address persistent deficits in quadriceps strength, neuromuscular control, and movement symmetry that often remain after standard rehabilitation.
The main questions it aimed to answer were:
Did the integration of TMR-a method focused on movement symmetry-into a BFR protocol lead to superior improvements in absolute quadriceps strength and subjective knee function as measured by IKDC scores? Did the combined BFR+TMR protocol result in significantly better functional balance and limb symmetry compared to BFR training alone? Researchers compared a BFR+TMR experimental group to a BFR-only control group. The primary objective was to see if the combined approach, which targeted both peripheral muscle capacity (via BFR) and central neuromotor control (via TMR), provided a more holistic and accelerated recovery than targeting muscular adaptations alone.
Complete a 6-month rehabilitation program consisting of supervised sessions three times per week.
Perform Blood Flow Restriction (BFR) training on the affected limb using an inflatable cuff at 60-80% occlusion pressure during low-load resistance exercises such as mini squats and knee extensions.
If assigned to the experimental group, perform Total Motion Release (TMR) exercises (including trunk rotations, side bending, and hip shifts) on the non-painful, contralateral side prior to the strengthening exercises.
Undergo periodic assessments including isometric strength testing with a dynamometer, the Single Leg Stance (SLS) test for balance, and the completion of the IKDC Subjective Knee Form.
Maintain a record of progress across four specific time points: baseline, 6 weeks, 12 weeks, and 6 months.
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
-
-
Punjab Province
-
Lahore、Punjab Province、パキスタン、54000
- Green International University
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 16-45 years.
- Both male and female patients.
- Underwent primary unilateral ACL reconstruction (hamstring or patellar tendon autograft).
- 2-4 weeks post-operative and cleared for supervised rehabilitation.
- Willing and able to provide informed consent.
Exclusion Criteria:
- Revision ACL surgery or multi-ligament injury.
- Concomitant fracture or meniscal repair requiring restricted rehab.
- History of DVT, vascular disease, uncontrolled hypertension, or cardiovascular disease.
- Neurological disorders affecting lower limb strength or balance.
- Contraindications to BFR (pregnancy, clotting disorders).
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：BFR + TMR Group
Describe the Blood Flow Restruction and the Total Motion Release exercises
|
Blood Flow Restriction (BFR): Use the exact same cuff and pressure settings as Group 1 so the comparison is fair. The Exercises: List the specific movements (e.g., Straight Leg Raises, Quad sets, or Knee Extensions). The Difference: State clearly: "This group receives standard BFR training and traditional physical therapy without any TMR protocols." Blood Flow Restriction (BFR): Specify the cuff type (e.g., automated or manual), the width of the cuff, and the pressure used (e.g., 80% of Limb Occlusion Pressure). Total Motion Release (TMR): Explain that you are using the "TMR protocol." Mention that you treat the "good" side or the "non-painful" side to influence the injured side. The Dose: How many minutes? How many times per week? (e.g., 30-minute sessions, 3 times per week for 12 weeks). The Difference: State clearly: "This group receives the TMR balancing protocol in addition to standard BFR training." |
|
アクティブコンパレータ：BFR Only Group
Describe only the blood flow restriction part.
|
Blood Flow Restriction (BFR): Use the exact same cuff and pressure settings as Group 1 so the comparison is fair. The Exercises: List the specific movements (e.g., Straight Leg Raises, Quad sets, or Knee Extensions). The Difference: State clearly: "This group receives standard BFR training and traditional physical therapy without any TMR protocols." |
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 |
|---|---|---|
|
Maximum Isometric Lower Limb Strength
時間枠：Basaeline, 6 weeks, 12 weeks and 6 months.
|
Maximum isometric force of the affected limb measured using a hand-held dynamometer.
This assesses the recovery from muscle atrophy and the return of power during the rehabilitation period.
|
Basaeline, 6 weeks, 12 weeks and 6 months.
|
|
Single Leg Stance (SLS) Test Time
時間枠：Basaeline, 6 weeks, 12 weeks and 6 months.
|
The duration a participant can stand unassisted on the injured leg without moving or compensating.
This test determines the regain of static balance and proprioception.
|
Basaeline, 6 weeks, 12 weeks and 6 months.
|
|
Total Score of International Knee Documentation Committee (IKDC) Subjective Knee Form
時間枠：Baseline, 6 weeks, 12 weeks, and 6 months.
|
The IKDC Subjective Knee Form is a patient-reported outcome measure used to assess functional disability.
It combines 18 items covering three domains: symptoms, physical activity, and knee function.
All individual items are summed and transformed into a total score.
A score of 100 indicates no limitation in activities of daily living or sports, while a score of 0 indicates maximum limitation.
This measure provides a single aggregated value of the participant's self-reported functional status.
|
Baseline, 6 weeks, 12 weeks, and 6 months.
|
協力者と研究者
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
本研究に関する用語
キーワード
その他の研究ID番号
- GIU/REC/26-30 (その他の識別子：Research Ethical Committee, Green International University)
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
ACL損傷の臨床試験
-
Zagazig University積極的、募集していないGrade III Traumatic Splenic Injury in Hemodynamically Stable Patientsエジプト
-
Gulf Medical Universityまだ募集していませんACL の再構築 | ACL修復
-
Vanderbilt University Medical CenterThe Cleveland Clinic完了
-
Dr. Lutfi Kirdar Kartal Training and Research Hospitalまだ募集していません前十字靭帯 (ACL) 再建 | 前十字靭帯 (ACL) 損傷 | 前十字靭帯（ACL）破裂トルコ（Türkiye）
-
Steadman Philippon Research InstituteÖssur Iceland ehf引きこもった
-
Campbell ClinicWashington University School of Medicine; University of Pittsburgh; Duke University; University... と他の協力者引きこもった
-
University Hospital, CaenINSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie積極的、募集していない
-
St. Olavs HospitalHaraldsplass Deaconess Hospital; Lovisenberg Diakonale Hospital完了
Blood Flow Restrictionの臨床試験
-
Assistance Publique - Hôpitaux de Paris完了
-
Microvention-Terumo, Inc.Bright Research Partnersまだ募集していません急性虚血性脳卒中
-
Insel Gruppe AG, University Hospital Bern募集
-
University of Alabama at BirminghamWillow Laboratories, Inc.まだ募集していません
-
Dalia Sameh Fawziまだ募集していません咬合面齲蝕 | 無作為化臨床試験 | 複合樹脂 | う蝕リスクの高いクラス I の虫歯 | クラス I コンポジット修復 | 複合修復 | 繊維強化複合材 | 注入可能な複合材
-
University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National Human Genome... と他の協力者完了新生児スクリーニング