NCT06756815

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

November 18, 2024

Last Update Submit

January 1, 2025

Conditions

Keywords

Anterior Cruciate Ligamentcross brace movementdynamic stabilizationFunctional movement

Outcome Measures

Primary Outcomes (4)

  • International Knee Documentation Committee score

    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

    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

    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)

    6 week

  • Functional Movement Screening

    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.

    6 week

Study Arms (2)

Group A: Cross bracing + conservative treatment(control group)

EXPERIMENTAL

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. Hamstring Curls 3. Step-ups 4. Mini Squats (with support) 5. Leg Press 6. Lateral Leg Raises 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

Other: Cross bracing and conservative treatment

Group B: Cross bracing + DNS training + conservative treatment

EXPERIMENTAL

Week 1-2 1. Cross Bracing (Isometric Holds) 2. DNS Core Activation (supine, prone positions) 3. Quad Sets 4. Straight Leg Raise 5. Ankle Pumps 6. Heel and Toe Raises 7. Glute Bridge Week 3-4 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 1. Cross Bracing (Isometric Holds) 2. DNS Dynamic Stabilization (with resistance) 3. Single-leg Balance (with and without support) 4. Lunges (with added resistance) 5. Squats (bodyweight or weighted) 6. Box Jumps 7. Lateral Step-ups 8. Running Drills (if tolerated)

Other: Cross bracing and DNS with conservative treatment

Interventions

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

Also known as: • Landing Error Scoring System, • International Knee Documentation Committee (IKDC) score, • Functional Movement Screening
Group A: Cross bracing + conservative treatment(control group)

Week Exercise Training Frequency (sets x reps) Week 1-2 1. Cross Bracing (Isometric Holds) 2. DNS Core Activation (supine, prone positions) 3. Quad Sets 4. Straight Leg Raise 5. Ankle Pumps 6. Heel and Toe Raises 7. Glute Bridge 2 sets x 10 reps Week 3-4 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 1. Cross Bracing (Isometric Holds) 2. DNS Dynamic Stabilization (with resistance) 3. Single-leg Balance (with and without support) 4. Lunges (with added resistance) 5. Squats (bodyweight or weighted) 6. Box Jumps 7. Lateral Step-ups 8. Running Drills (if tolerated) 3 sets x 15 reps

Group B: Cross bracing + DNS training + conservative treatment

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSRD

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 31279767BACKGROUND
  • 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.

    PMID: 31950895BACKGROUND
  • 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.

    PMID: 28966380BACKGROUND
  • 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.

    PMID: 31431274BACKGROUND
  • 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.

    PMID: 34035951BACKGROUND
  • 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.

    PMID: 31041331BACKGROUND
  • Book E, Noyes FR, editors. Read Online The Anterior Cruciate Ligament Reconstruction And Basic Science E Book Anterior Cruciate Ligament: Reconstruction and Basic Science2022.

    BACKGROUND
  • 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.

    PMID: 37316199BACKGROUND
  • 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.

    PMID: 36918020BACKGROUND

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Amir Gul Memon, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

January 3, 2025

Study Start

April 1, 2024

Primary Completion

August 1, 2024

Study Completion

September 30, 2024

Last Updated

January 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations