External Focus of Attention Posttraumatic Osteoarthritis
Primary Purpose
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internal focus of attention feedback
External focus of attention feedback
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries
Eligibility Criteria
Inclusion Criteria:
- history of primary, unilateral ACL reconstruction 6-24 months prior to enrollment
- cleared to return to full activity by treating orthopedic surgeon
Exclusion Criteria:
- Body mass index >35 kg/m2
- History of musculoskeletal injury sustained 3 months prior to enrollment
- Current participation in formal post-operative rehabilitation
Sites / Locations
- UNC CharlotteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Internal focus of attention feedback
External focus of attention feedback
Arm Description
Participants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns.
Participants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser.
Outcomes
Primary Outcome Measures
Changes from baseline in lower extremity biomechanics during walking
Knee and hip angles and loads measured via 3D biomechanics
Knee cartilage health
Knee cartilage thickness measured using diagnostic ultrasound imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT04922268
First Posted
June 4, 2021
Last Updated
June 13, 2023
Sponsor
University of North Carolina, Charlotte
Collaborators
Arthritis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04922268
Brief Title
External Focus of Attention Posttraumatic Osteoarthritis
Official Title
External Focus of Attention Feedback to Mitigate Posttraumatic Osteoarthritis Risk After ACL Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Charlotte
Collaborators
Arthritis Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Osteo Arthritis Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internal focus of attention feedback
Arm Type
Active Comparator
Arm Description
Participants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns.
Arm Title
External focus of attention feedback
Arm Type
Experimental
Arm Description
Participants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser.
Intervention Type
Other
Intervention Name(s)
Internal focus of attention feedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
External focus of attention feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline in lower extremity biomechanics during walking
Description
Knee and hip angles and loads measured via 3D biomechanics
Time Frame
1-week post-intervention, 4-weeks post-intervention
Title
Knee cartilage health
Description
Knee cartilage thickness measured using diagnostic ultrasound imaging
Time Frame
1-week post-intervention, 4-weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
history of primary, unilateral ACL reconstruction 6-24 months prior to enrollment
cleared to return to full activity by treating orthopedic surgeon
Exclusion Criteria:
Body mass index >35 kg/m2
History of musculoskeletal injury sustained 3 months prior to enrollment
Current participation in formal post-operative rehabilitation
Facility Information:
Facility Name
UNC Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28223
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abbey Thomas, PhD
Phone
704-687-8628
Email
afenwick@charlotte.edu
First Name & Middle Initial & Last Name & Degree
Luke Donovan, PhD
First Name & Middle Initial & Last Name & Degree
Tricia Turner, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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External Focus of Attention Posttraumatic Osteoarthritis
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