NCT04914689

Brief Summary

Knee injuries, especially those to the ACL, are common among physically active people. Preventing these injuries from happening is critical to limiting the long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns to prevent injury than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as landing from a box and running and cutting. After this initial assessment, you will be randomly allocated to one of 3 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people land from a jump. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 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

First Submitted

Initial submission to the registry

June 3, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

3.5 years

First QC Date

June 3, 2021

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline in lower extremity biomechanics during landing.

    Hip and knee angles and loads measured via 3D biomechanics

    1-week post-intervention, 4-weeks post-intervention

  • Differences in biomechanical changes between visual and auditory external focus of attention feedback.

    Hip and knee angles and loads measured via 3D biomechanics

    1-week post-intervention, 4-weeks post-intervention

Secondary Outcomes (1)

  • Changes from baseline in cortical activity during landing

    1-week post-intervention, 4-weeks post-intervention

Study Arms (3)

Internal focus of attention feedback

ACTIVE COMPARATOR

Participants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns.

Other: Internal focus of attention feedback

Visual external focus of attention feedback

EXPERIMENTAL

Participants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser.

Other: Visual internal focus of attention feedback

Auditory external focus of attention feedback

EXPERIMENTAL

Participants will complete 12 sessions over 3 weeks receiving auditory feedback of their movement patterns.

Other: Auditory external focus of attention feedback

Interventions

Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving mirror feedback. Participants will be instructed to perform each functional task in a manner that keeps their knee in line with their toes.

Internal focus of attention feedback

Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving visual feedback via laser. Participants will be instructed to perform each functional task in a manner that does causes the laser to move up and down but not side-to-side.

Visual external focus of attention feedback

Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving auditory feedback. Participants will be instructed to perform each functional task in a manner that does not cause the auditory tool to elicit a noise.

Auditory external focus of attention feedback

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • exercise 30+ minutes 3+ days/week

You may not qualify if:

  • Body mass index \>40 kg/m2
  • History of lower extremity fracture or surgery to either limb
  • History of ACL tear, meniscus, or collateral ligament injury at the knee to either limb
  • History of ankle sprains to either limb
  • History of musculoskeletal injury sustained in the 6 months prior to enrollment
  • History of concussion or neurological disorders that may influence electroencephalography activity
  • Visual or hearing impairments that would limit receiving the appropriate feedback
  • Inability to comprehend and repeat back directions in English
  • Current smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Charlotte

Charlotte, North Carolina, 28223, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 7, 2021

Study Start

August 15, 2021

Primary Completion

February 28, 2025

Study Completion

March 31, 2025

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations