NCT02754700

Brief Summary

This study will identify the most optimal, focused approach for biofeedback in adolescent females at high risk for anterior cruciate ligament (ACL) injury. A six-week randomized, pre/post-testing design will be used to identify biofeedback training effects. The investigators will also determine the effects of hip strategy on retention of decreased knee abduction load with focused biofeedback. A six-month follow-up design will be used to test retention of real-time biofeedback intervention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2016

Typical duration for phase_2

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, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

April 20, 2016

Last Update Submit

February 20, 2019

Conditions

Keywords

Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

  • Knee abduction load

    Knee abduction load will be the primary outcome measure. This is assessed with three-dimensional motion analysis techniques and a detailed full-body biomechanical model during dynamic landing tasks immediately before and after 6 weeks of the study intervention. The unit of measure for knee abduction load is Nm and will be normalized to participant mass when appropriate.

    6 weeks

Secondary Outcomes (1)

  • Knee abduction load

    6 months

Study Arms (3)

Biofeedback Hip

EXPERIMENTAL

Hip focused biofeedback with neuromuscular training

Other: Hip Focused ROBUST Training

Biofeedback Knee

EXPERIMENTAL

Knee focused biofeedback with neuromuscular training

Other: Knee Focused ROBUST Training

Neuromuscular Training

ACTIVE COMPARATOR

Neuromuscular Training component

Other: Neuromuscular Training

Interventions

Standardized, comprehensive neuromuscular training

Neuromuscular Training

Biofeedback training focused on the hip extensors

Biofeedback Hip

Biofeedback training focused on knee abduction

Biofeedback Knee

Eligibility Criteria

Age9 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Currently participating on club or school sponsored soccer team

You may not qualify if:

  • Current injury that limits participating in sport
  • Male
  • Cannot participate in a 6-week intervention due to time or other constraints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ford KR, Taylor JB, Westbrook AE, Paterno MV, Huang B, Nguyen AD. Outcomes of a randomized controlled trial of neuromuscular training with real-time biofeedback in young female athletes. BMC Musculoskelet Disord. 2025 Apr 15;26(1):366. doi: 10.1186/s12891-025-08647-3.

  • Taylor JB, Nguyen AD, Paterno MV, Huang B, Ford KR. Real-time optimized biofeedback utilizing sport techniques (ROBUST): a study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Feb 7;18(1):71. doi: 10.1186/s12891-017-1436-1.

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Kevin Ford, PhD

    High Point University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 28, 2016

Study Start

April 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

February 22, 2019

Record last verified: 2019-02