NCT04967937

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

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

November 30, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 19, 2021

Last Update Submit

July 19, 2021

Conditions

ACL Injury

Keywords

Single limb stabilityNeuromuscular TrainingFemale athletesACL

Outcome Measures

Primary Outcomes (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

    6th Week

Secondary Outcomes (1)

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

    6th Week

Other Outcomes (1)

  • iii. Stork balance test

    6th Week

Study Arms (1)

Single-Group

EXPERIMENTAL

The 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.

Other: Strengthening, resistance exercise, plyometric and dynamic movement training

Interventions

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.

Single-Group

Eligibility Criteria

Age13 Years - 20 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale athletes
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Any malignancy
  • Infection
  • Systemic illness
  • Trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samnabad Sports complex

Faisalābad, Punjab Province, Pakistan

Location

Related Publications (12)

  • 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.

    PMID: 12671485BACKGROUND

  • 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.

    PMID: 27367045BACKGROUND

  • 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.

    PMID: 20108849BACKGROUND

  • 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.

    PMID: 18835221BACKGROUND

  • 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.

    PMID: 10569367BACKGROUND

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

    PMID: 16558559BACKGROUND

  • 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.

    PMID: 10569353BACKGROUND

  • 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.

    PMID: 17488502BACKGROUND

  • 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.

    PMID: 18359820BACKGROUND

  • 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.

    PMID: 16382007BACKGROUND

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

    PMID: 16558558BACKGROUND

  • 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.

    PMID: 23048042BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Syed Shakil Ur Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 20, 2021

Study Start

November 30, 2020

Primary Completion

April 30, 2021

Study Completion

June 30, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)