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ACL InjuryNCT04967937

Neuromuscular Training Improves Single-Limb Stability

A study testing Strengthening, resistance exercise, plyometric and dynamic movement training in people with ACL Injury, 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

Pretest/post-test study design, study will try to determine if a 6-week neuromuscular training program designed to decrease the incidence of anterior cruciate ligament (ACL) injuries would improve single-limb stability in young female athletes. Healthy female high school athletes will participate in this study. Read more about this study

Who is it for?
Ages 13 to 20 years, women onlyHealthy volunteers can take part
Conditions the study is for
ACL Injury
What is being tested?
Strengthening, resistance exercise, plyometric and dynamic movement training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 sitePakistan
Study dates
30 Nov 2020to 30 Jun 2021
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 13 to 20 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Age will range from 13-20
  • Female participants
  • Individuals with Postural instability and Impaired balance will be included.

Who cannot join

  • Any malignancy
  • Infection
  • Systemic illness
  • Trauma

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Samnabad Sports complex

    Faisalābad, Punjab Province

Other trials in Pakistan

About this study

Official title: Neuromuscular Training Improves Single-Limb Stability in Young Female Athletes

Pretest/post-test study design, study will try to determine if a 6-week neuromuscular training program designed to decrease the incidence of anterior cruciate ligament (ACL) injuries would improve single-limb stability in young female athletes. Healthy female high school athletes will participate in this study. Single-limb postural stability for both lower extremities will be assessed with Stork balance test, Star Excursion Balance Test for Dynamic Balance and Single leg stance test for static balance. Participants will be included through convenient sampling. Informed consent will be taken from all the participants.

Read the detailed description

In this Controlled single-group pretest/post-test study design, study will try to determine if a 6-week neuromuscular training program designed to decrease the incidence of anterior cruciate ligament (ACL) injuries would improve single-limb stability in young female athletes. Current study hypothesized that neuromuscular training would result in an improvement of postural stability, with the greatest improvement taking place in the medial-lateral direction. Healthy female high school athletes will participate in this study. Single-limb postural stability for both lower extremities will be assessed with Stork balance test, Star Excursion Balance Test for Dynamic Balance and Single leg stance test for static balance. Participants will be included through convenient sampling. Informed consent will be taken from all the participants. Those individuals who will match the inclusion and exclusion criteria will be a part of the study. The neuromuscular training program will consist of three 90-minute training sessions per week for 6 weeks. Following the completion of the training program, each subject will be re-evaluated to determine change in total, anterior-posterior, and medial-lateral single-limb stability.

Conditions
ACL Injury
Being tested
Strengthening, resistance exercise, plyometric and dynamic movement training
Keywords
Single limb stability, Neuromuscular Training, Female athletes, ACL
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

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

  • Strengthening, resistance exercise, plyometric and dynamic movement trainingOther

    (1) balance training and hip/pelvis/trunk strengthening, (2) plyometrics and dynamic movement training, and (3) resistance training.

Study groups in NCT04967937
Study groupRoleWhat they receive
Single-GroupExperimentalThe neuromuscular training program will consist of three 90-minute training sessions per week for 6 weeks. The 3 components of the dynamic neuromuscular training protocol utilized in this study include: (1) balance training and hip/pelvis/trunk strengthening, (2) plyometrics and dynamic movement training, and (3) resistance training. Following the completion of the training program, each subject will be re-evaluated to determine change in total, anterior-posterior, and medial-lateral single-limb stability. Two-way analysis of variance models will be used to determine differences between pre-training and post-training and between limbs.
Receives: Other: Strengthening, resistance exercise, plyometric and dynamic movement training

What is being measured

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

  1. i. Star Excursion Balance Test for Dynamic Balance

    dynamic test that requires strength, flexibility, and proprioception. It is a measure of dynamic balance that provides a significant challenge to athletes and physically active individuals. The test can be used to assess physical performance

    Measured: 6th Week

Secondary outcomes (1)

  1. ii. Single Limb Stance Test (Static Posture and Balance)

    The Single leg Stance (SLS) Test is used to assess static postural and balance control.Performed with eyes open and hands on the hips.Client must stand unassisted on one leg

    Measured: 6th Week

Timeline

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

  1. First posted20 Jul 2021
  2. Study start30 Nov 2020
  3. Primary completion30 Apr 2021
  4. Study completion30 Jun 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04967937
Sponsor's protocol ID
REC/Lhr/21/0414 Shah bano
Status last verified
Jul 2021
First submitted
19 Jul 2021
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Etty Griffin LY. Neuromuscular training and injury prevention in sports. Clin Orthop Relat Res. 2003 Apr;(409):53-60. doi: 10.1097/01.blo.0000057788.10364.aa.

    PubMed 12671485

  • Richmond SA, Kang J, Doyle-Baker PK, Nettel-Aguirre A, Emery CA. A School-Based Injury Prevention Program to Reduce Sport Injury Risk and Improve Healthy Outcomes in Youth: A Pilot Cluster-Randomized Controlled Trial. Clin J Sport Med. 2016 Jul;26(4):291-8. doi: 10.1097/JSM.0000000000000261.

    PubMed 27367045

  • McLeod TC, Armstrong T, Miller M, Sauers JL. Balance improvements in female high school basketball players after a 6-week neuromuscular-training program. J Sport Rehabil. 2009 Nov;18(4):465-81. doi: 10.1123/jsr.18.4.465.

    PubMed 20108849

  • Gianotti SM, Marshall SW, Hume PA, Bunt L. Incidence of anterior cruciate ligament injury and other knee ligament injuries: a national population-based study. J Sci Med Sport. 2009 Nov;12(6):622-7. doi: 10.1016/j.jsams.2008.07.005. Epub 2008 Oct 2.

    PubMed 18835221

  • Viola RW, Steadman JR, Mair SD, Briggs KK, Sterett WI. Anterior cruciate ligament injury incidence among male and female professional alpine skiers. Am J Sports Med. 1999 Nov-Dec;27(6):792-5. doi: 10.1177/03635465990270061701.

    PubMed 10569367

  • Bonci CM. Assessment and evaluation of predisposing factors to anterior cruciate ligament injury. J Athl Train. 1999 Apr;34(2):155-64.

    PubMed 16558559

  • Hewett TE, Lindenfeld TN, Riccobene JV, Noyes FR. The effect of neuromuscular training on the incidence of knee injury in female athletes. A prospective study. Am J Sports Med. 1999 Nov-Dec;27(6):699-706. doi: 10.1177/03635465990270060301.

    PubMed 10569353

  • Myer GD, Ford KR, Brent JL, Hewett TE. Differential neuromuscular training effects on ACL injury risk factors in"high-risk" versus "low-risk" athletes. BMC Musculoskelet Disord. 2007 May 8;8:39. doi: 10.1186/1471-2474-8-39.

    PubMed 17488502

  • Chappell JD, Limpisvasti O. Effect of a neuromuscular training program on the kinetics and kinematics of jumping tasks. Am J Sports Med. 2008 Jun;36(6):1081-6. doi: 10.1177/0363546508314425. Epub 2008 Mar 21.

    PubMed 18359820

  • Hewett TE, Ford KR, Myer GD. Anterior cruciate ligament injuries in female athletes: Part 2, a meta-analysis of neuromuscular interventions aimed at injury prevention. Am J Sports Med. 2006 Mar;34(3):490-8. doi: 10.1177/0363546505282619. Epub 2005 Dec 28.

    PubMed 16382007

  • Ireland ML. Anterior cruciate ligament injury in female athletes: epidemiology. J Athl Train. 1999 Apr;34(2):150-4.

    PubMed 16558558

  • Myer GD, Sugimoto D, Thomas S, Hewett TE. The influence of age on the effectiveness of neuromuscular training to reduce anterior cruciate ligament injury in female athletes: a meta-analysis. Am J Sports Med. 2013 Jan;41(1):203-15. doi: 10.1177/0363546512460637. Epub 2012 Oct 9.

    PubMed 23048042

Questions about this trial

What is this clinical trial studying?

A study testing Strengthening, resistance exercise, plyometric and dynamic movement training in people with ACL Injury, 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 3 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 20 Jul 2021. 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?

i. Star Excursion Balance Test for Dynamic Balance (time frame: 6th Week). 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 NCT04967937, which also lists 12 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 20 Jul 2021.

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