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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
University of North Carolina, Charlotte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 4, 2021
Last Updated
June 13, 2023
Sponsor
University of North Carolina, Charlotte
Collaborators
Arthritis Foundation
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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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