External Focus of Attention Posttraumatic Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

External Focus of Attention Feedback to Mitigate Posttraumatic Osteoarthritis Risk After ACL Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922268
• Other study ID #: 21-0509
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2023
• Source: University of North Carolina, Charlotte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Rupture

Intervention

Other:
• Internal focus of attention feedback
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.
• External 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.

Locations

Country	Name	City	State
United States	UNC Charlotte	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Charlotte	Arthritis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Knee cartilage health	Knee cartilage thickness measured using diagnostic ultrasound imaging	1-week post-intervention, 4-weeks post-intervention