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AzTrials

Sports Physical TherapyNCT06756815

Cross Bracing Protocol With And Without Dynamic Neuromuscular Stabilization Training in Athletes

A study testing Cross bracing and conservative treatment and Cross bracing and DNS with conservative treatment in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Sports Physical Therapy
What is being tested?
Cross bracing and conservative treatment and Cross bracing and DNS with conservative treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 sitePakistan
Study dates
1 Apr 2024to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • PSRD

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: 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 .

Read the detailed description

The study's emphasis on cross bracing protocol and DNS training is warranted due to the necessity of investigating non-invasive and conservative therapy methods that have the ability to improve functional movements in athletes with ACL Injury . Cross bracing is frequently employed to offer external reinforcement and enhance stability to the knee joint subsequent to an ACL damage, whereas DNS training concentrates on reconditioning the neuromuscular system to enhance movement patterns and motor control. The study seeks to provide significant insights into the most effective rehabilitation regimens for athletes with acute ACL Injury by evaluating the effects of two therapies. The ultimate goal is to enhance their functional results and long-term sports performance.

Being tested
Cross bracing and conservative treatment, Cross bracing and DNS with conservative treatment
Keywords
Anterior Cruciate Ligament, cross brace movement, dynamic stabilization, Functional movement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cross bracing and conservative treatmentOther

    Also called • Landing Error Scoring System, • International Knee Documentation Committee (IKDC) score, • Functional Movement Screening

    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

  • Cross bracing and DNS with conservative treatmentOther

    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
    8. 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
    9. Cross Bracing (Isometric Holds)
    10. DNS Dynamic Stabilization (with resistance)
    11. Single-leg Balance (with and without support)
    12. Lunges (with added resistance)
    13. Squats (bodyweight or weighted)
    14. Box Jumps
    15. Lateral Step-ups
    16. Running Drills (if tolerated) 3 sets x 15 reps
Study groups in NCT06756815
Study groupRoleWhat they receive
Group A: Cross bracing + conservative treatment(control group)ExperimentalCross 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
Receives: Other: Cross bracing and conservative treatment
Group B: Cross bracing + DNS training + conservative treatmentExperimentalWeek 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)
Receives: Other: Cross bracing and DNS with conservative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 week

  2. 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.

    Measured: 6 week

  3. 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)

    Measured: 6 week

  4. 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.

    Measured: 6 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2025
  2. Study start1 Apr 2024
  3. Primary completion1 Aug 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06756815
Sponsor's protocol ID
REC/RCR & AHS/24/0420
Status last verified
Jan 2025
First submitted
18 Nov 2024
Last updated
3 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31279767
  • 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.

    PubMed 31950895
  • 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.

    PubMed 28966380
  • 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.

    PubMed 31431274
  • 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.

    PubMed 34035951
  • 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.

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

  • 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.

    PubMed 37316199
  • 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.

    PubMed 36918020

Questions about this trial

What is this clinical trial studying?

A study testing Cross bracing and conservative treatment and Cross bracing and DNS with conservative treatment in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Knee Documentation Committee score (time frame: 6 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06756815, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.

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