External Focus of Attention Posttraumatic Osteoarthritis
External Focus of Attention Feedback to Mitigate Posttraumatic Osteoarthritis Risk After ACL Reconstruction
1 other identifier
interventional
45
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
June 10, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedDecember 24, 2024
December 1, 2024
2.4 years
June 4, 2021
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 COMPARATORParticipants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns.
External focus of attention feedback
EXPERIMENTALParticipants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser.
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.
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.
Eligibility Criteria
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
- University of North Carolina, Charlottelead
- Arthritis Foundationcollaborator
Study Sites (1)
UNC Charlotte
Charlotte, North Carolina, 28223, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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