NCT04922268

Brief Summary

Knee injuries, especially those to the ACL, are common among physically active people. These injuries are frequently treated with surgical reconstruction (ACL reconstruction; ACLR). While ACLR restores stability it does not protect against future injury, 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 that are known risk factors of posttraumatic osteoarthritis development 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 walking and hopping. After this initial assessment, you will be randomly allocated to one of 2 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people walk. 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 Jan 2022

Typical duration 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 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

2.4 years

First QC Date

June 4, 2021

Last Update Submit

December 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline in lower extremity biomechanics during walking

    Knee and hip angles and loads measured via 3D biomechanics

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

  • Knee cartilage health

    Knee cartilage thickness measured using diagnostic ultrasound imaging

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

Study Arms (2)

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

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: 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.

External focus of attention feedback

Eligibility Criteria

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

You may qualify if:

  • history of primary, unilateral ACL reconstruction 6-24 months prior to enrollment
  • cleared to return to full activity by treating orthopedic surgeon

You may not qualify if:

  • Body mass index \>35 kg/m2
  • History of musculoskeletal injury sustained 3 months prior to enrollment
  • Current participation in formal post-operative rehabilitation

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 10, 2021

Study Start

January 1, 2022

Primary Completion

May 31, 2024

Study Completion

August 31, 2024

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations