- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06756815
Cross Bracing Protocol With And Without Dynamic Neuromuscular Stabilization Training in Athletes
Effects of Cross Bracing Protocol With And Without Dynamic Neuromuscular Stabilization Training on Functional Movements in Athletes With Acute Anterior Cruciate Ligament Injury
ACL Injury is a severe injury for athletes, which frequently results in functional limits and a higher likelihood of re-injury. Although bracing regimens are frequently used in rehabilitation, their ability to restore functional movements after an ACL Injury is still uncertain. Dynamic neuromuscular stabilization (DNS) training, which targets the core and proprioception, has emerged as a viable method for enhancing motor control and decreasing knee instability. The objective of this study is to examine the synergistic impact of cross bracing and DNS training on the functional movements of athletes who have recently experienced an ACL Injury .
A randomized controlled trial will be conducted to study the effects of different interventions on athletes with acute ACL Injury. The participants will be divided into two groups: (A= control group) Cross bracing with conservative treatment, (B= Treatment group) Cross bracing + DNS training with conservative treatment. Both groups will engage in targeted exercises that aim to activate the core, improve proprioception, and enhance movement patterns. The participants' functional movements will be assessed at the beginning of the study and 6 weeks later using established questionnaire such as International Knee Documentation Committee (IKDC) score - assesses knee function and symptoms, Landing error scoring system (LESS), Y Balance (YB), Functional movement screening (FMS) Statistical analysis will be performed to compare the functional performance and neuromuscular parameters between the groups in order to determine the most effective intervention for restoring movement quality after ACL Injury .
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- PSRD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and Female
- Age: 18-30 years.
- Mentally and verbally capable of participating in the study.
- Positive Lachman Test
- Diagnosis of acute ACL Injury with grade 1 and 2 through MRI or arthroscopy.
Exclusion Criteria:
- Inflammatory disease, rheumatoid arthritis, spondyloarthropathy or active malignancy.
- Neurological disorder or systemic disease.
- Previous surgery on the affected knee.
- Meniscal tear or articular cartilage damage requiring surgical repair
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: Cross bracing + conservative treatment(control group)
Cross brace training week 1-2 1. Cross Bracing (Isometric Holds) 2. Quad Sets 3. Straight Leg Raise 4. Ankle Pumps 5. Heel and Toe Raises 6. Glute Bridge Week 3-4
1. Cross Bracing (Isometric Holds) 2. Single-leg Balance (with support) 3. Lunges (with proper technique) 4. Squats (bodyweight) 5. Box Jumps 6. Lateral Step-ups |
Week Exercise Training Frequency (sets x reps) Week 1-2 1. Cross Bracing (Isometric Holds) 2. Quad Sets 3. Straight Leg Raise 4. Ankle Pumps 5. Heel and Toe Raises 6. Glute Bridge 2 sets x 10 reps Week 3-4 1. Cross Bracing (Isometric Holds) 2. Hamstring Curls 3. Step-ups 4. Mini Squats (with support) 5. Leg Press 6. Lateral Leg Raises 3 sets x 12 reps Week 5-6 1. Cross Bracing (Isometric Holds) 2. Single-leg Balance (with support) 3. Lunges (with proper technique) 4. Squats (bodyweight) 5. Box Jumps 6. Lateral Step-ups 3 sets x 15 reps
Other Names:
|
|
Experimental: Group B: Cross bracing + DNS training + conservative treatment
Week 1-2
1. Cross Bracing (Isometric Holds) 2. DNS Core Stabilization (advanced activation) 3. Hamstring Curls 4. Step-ups 5. Mini Squats 6. Leg Press 7. Lateral Leg Raises 8. Pelvic Tilts Week 5-6
|
Week Exercise Training Frequency (sets x reps) Week 1-2
1. Cross Bracing (Isometric Holds) 2. DNS Core Stabilization (advanced activation) 3. Hamstring Curls 4. Step-ups 5. Mini Squats 6. Leg Press 7. Lateral Leg Raises 8. Pelvic Tilts 3 sets x 12 reps Week 5-6
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Knee Documentation Committee score
Time Frame: 6 week
|
The International Knee Documentation Committee (IKDC) Subjective Knee Form is a patient-oriented questionnaire that assesses symptoms and function in daily living activities.
The purpose of this study was to validate the IKDC Subjective Knee Form in a large patient population with various knee disorders.
It contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items).
Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
The overall IKDC score showed acceptable test-retest reliability with an interclass correlation of 0.95.
|
6 week
|
|
Landing Error Scoring System
Time Frame: 6 week
|
The Landing Error Scoring System (LESS) is a clinical tool often used in research and practice to identify athletes presenting high injury-risk biomechanical patterns during a jump-landing task.
It is used to identify the risk of non-contact injuries during jumping and landing movements.
It assesses 9 landing concepts and has 17 questions which are scored out of 19 points.
Interrater reliability (ICC2, 1) for the LESS-RT ranged from .72 to .81 with standard error of measurements ranging from .69 to .79.
|
6 week
|
|
Y- Balance Test
Time Frame: 6 week
|
The Y Balance Test was developed as a test of dynamic postural control and has been shown to be predictive of lower-extremity injury.
It can be used for both the upper quarter and lower quarter.
The YBT for the lower quarter (LQYBT) has been thoroughly researched as its protocol is based on research done on the Star Excursion Balance Test.
The Star Excursion Balance Test demonstrated reliable results on its ability to predict LE injury in high school basketball players.
The YBT has proven to have very good levels of interrater test-retest reliability (ICC = 0.80 - 0.85)
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6 week
|
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Functional Movement Screening
Time Frame: 6 week
|
The Functional Movement Screen (FMS) is utilized by professional and collegiate sports teams and the military for the prevention of musculoskeletal injuries.
The FMS is a tool used to identify asymmetries which result in functional movement deficiencies.
The FMS aims to identify imbalances in mobility and stability during seven fundamental movement patterns.
ICC values of 0.90-0.99
indicated excellent reliability, 0.80-0.89
indicated good reliability, 0.70-0.79
indicated fair reliability, and 0-0.69 indicated poor reliability.
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6 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amir Gul Memon, MS, Riphah International University
Publications and helpful links
General Publications
- Mahdieh L, Zolaktaf V, Karimi MT. Effects of dynamic neuromuscular stabilization (DNS) training on functional movements. Hum Mov Sci. 2020 Apr;70:102568. doi: 10.1016/j.humov.2019.102568. Epub 2020 Jan 13.
- Filbay SR, Grindem H. Evidence-based recommendations for the management of anterior cruciate ligament (ACL) rupture. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):33-47. doi: 10.1016/j.berh.2019.01.018. Epub 2019 Feb 21.
- Filbay SR, Dowsett M, Chaker Jomaa M, Rooney J, Sabharwal R, Lucas P, Van Den Heever A, Kazaglis J, Merlino J, Moran M, Allwright M, Kuah DEK, Durie R, Roger G, Cross M, Cross T. Healing of acute anterior cruciate ligament rupture on MRI and outcomes following non-surgical management with the Cross Bracing Protocol. Br J Sports Med. 2023 Dec;57(23):1490-1497. doi: 10.1136/bjsports-2023-106931. Epub 2023 Jun 14.
- Yang XG, Feng JT, He X, Wang F, Hu YC. The effect of knee bracing on the knee function and stability following anterior cruciate ligament reconstruction: A systematic review and meta-analysis of randomized controlled trials. Orthop Traumatol Surg Res. 2019 Oct;105(6):1107-1114. doi: 10.1016/j.otsr.2019.04.015. Epub 2019 Jul 3.
- Raines BT, Naclerio E, Sherman SL. Management of Anterior Cruciate Ligament Injury: What's In and What's Out? Indian J Orthop. 2017 Sep-Oct;51(5):563-575. doi: 10.4103/ortho.IJOrtho_245_17.
- Dunphy E, Button K, Hamilton F, Williams J, Spasic I, Murray E. Feasibility randomised controlled trial comparing TRAK-ACL digital rehabilitation intervention plus treatment as usual versus treatment as usual for patients following anterior cruciate ligament reconstruction. BMJ Open Sport Exerc Med. 2021 May 5;7(2):e001002. doi: 10.1136/bmjsem-2020-001002. eCollection 2021.
- Greenberg EM, Greenberg ET, Albaugh J, Storey E, Ganley TJ. Anterior Cruciate Ligament Reconstruction Rehabilitation Clinical Practice Patterns: A Survey of the PRiSM Society. Orthop J Sports Med. 2019 Apr 23;7(4):2325967119839041. doi: 10.1177/2325967119839041. eCollection 2019 Apr.
- Book E, Noyes FR, editors. Read Online The Anterior Cruciate Ligament Reconstruction And Basic Science E Book Anterior Cruciate Ligament: Reconstruction and Basic Science2022.
- Karimijashni M, Sarvestani FK, Yoosefinejad AK. The Effect of Contralateral Knee Neuromuscular Exercises on Static and Dynamic Balance, Knee Function, and Pain in Athletes Who Underwent Anterior Cruciate Ligament Reconstruction: A Single-Blind Randomized Controlled Trial. J Sport Rehabil. 2023 Mar 14;32(5):524-539. doi: 10.1123/jsr.2021-0380. Print 2023 Jul 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/RCR & AHS/24/0420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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