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Optimizing Movement After ACL Injury

Primary Purpose

Anterior Cruciate Ligament Injuries, Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Squat Biofeedback
Standard Care
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

13 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute ACL injury in the past 6 months
  • have had ACL reconstruction in the past month or have a planned ACL reconstruction

Exclusion Criteria:

  • previous knee injury or surgery (either knee)
  • body mass index over 35 kg/m2
  • concomitant posterior cruciate ligament reconstruction or cartilage procedure that include extended weightbearing restrictions and/or changes to cartilage structure
  • current pregnancy
  • planned pregnancy during study duration

Sites / Locations

  • University of Nebraska Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Standard care.

Squat biofeedback intervention.

Outcomes

Primary Outcome Measures

Knee flexion moment impulse
Between-limb ratio of knee flexion moment impulse during descent and ascent phase of bilateral squat
Cartilage T2 relaxation time
Percent change in cartilage T2 relaxation time from 2 weeks to 6 months after ACL reconstruction

Secondary Outcome Measures

Knee flexion moment impulse
Between-limb ratio of knee flexion moment impulse during descent and ascent phase of bilateral squat
Peak knee flexion moment
Between-limb ratio of peak flexion moment during gait
Peak knee flexion moment
Between-limb ratio of peak flexion moment during gait
Cartilage T1rho relaxation time
Percent change in cartilage T1rho relaxation time from 2 weeks to 6 months after ACL reconstruction
Quadriceps strength
Between-limb ratio of isometric and isokinetic quadriceps strength
Quadriceps strength
Between-limb ratio of isometric and isokinetic quadriceps strength

Full Information

First Posted
May 2, 2022
Last Updated
September 28, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT05363683
Brief Title
Optimizing Movement After ACL Injury
Official Title
Optimizing Movement After Anterior Cruciate Ligament Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

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
This study will evaluate if a visual biofeedback program leads to improved knee outcomes after anterior cruciate ligament reconstruction. Outcome measures will include biomechanical movement patterns and markers of knee osteoarthritis on magnetic resonance imaging.
Detailed Description
Fifty percent of teenagers and young adults who suffer an anterior cruciate ligament (ACL) injury develop radiographic knee osteoarthritis (OA) within 15 years. The resulting pain, reduced quality-of-life, and increased risk for co-morbidity lead to substantial healthcare costs, inability to fulfill work and personal responsibilities, and reduced long-term health. Articular cartilage degeneration is the hallmark sign of early OA development after knee injury. This deterioration can be measured by increased T2 and T1rho relaxation time on quantitative magnetic resonance imaging (MRI), an imaging biomarker for OA development. Harmful increases in MRI markers of the knee's articular cartilage occur within months of ACL injury and indicate preventative interventions should begin soon after injury. However, evidence-based interventions to prevent OA do not exist. The investigators have shown that after ACL reconstruction (ACLR), patients exhibit asymmetric movement patterns characterized by up to 62% lower knee joint loading during walking and squatting in the injured limb at two months after ACLR. These knee joint loading patterns remain 40% lower at six months. Emerging evidence suggests knee joint unloading patterns after ACL injury may increase the risk for OA development. Currently, no studies have examined the efficacy of movement-focused interventions during the first months after ACLR, which explains the lack of evidence-based interventions that successfully increase knee loading early after ACLR. This gap presents a barrier to the research team's long-term goal of preventing OA in young, active individuals before irreversible knee degeneration occurs. This project will challenge the traditional OA paradigm that too much joint loading (e.g. "wear and tear") causes cartilage breakdown. The multi-disciplinary team spanning rehabilitation, orthopaedics, radiology and biomechanics has developed a novel visual biofeedback paradigm using portable force plates that can increase knee loading during squats within a single session after ACLR. This data suggest movement is modifiable using visual feedback, but its efficacy beyond a single training session is unknown. This study will determine the efficacy of the visual biofeedback program initiated two weeks after ACLR by assessing movement biomechanics and MRI changes in cartilage microstructure six months later. Successful completion of this project will establish the first rehabilitation intervention to effectively and optimally load the knee joint early after ACLR, providing the initial steps in the team's work to prevent OA after ACL injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Knee Osteoarthritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard care.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Squat biofeedback intervention.
Intervention Type
Procedure
Intervention Name(s)
Squat Biofeedback
Intervention Description
The intervention group will complete bilateral squats with each limb on a separate portable force plate. They will receive real-time visual feedback on a 32-inch screen during all squats. Biofeedback conditions will be progressed from simplest (ground reaction force only) to most complex (ground reaction force plus center of pressure). This intervention will be included in additional to standard care post-operative physical therapy.
Intervention Type
Procedure
Intervention Name(s)
Standard Care
Intervention Description
Standard care post-operative physical therapy
Primary Outcome Measure Information:
Title
Knee flexion moment impulse
Description
Between-limb ratio of knee flexion moment impulse during descent and ascent phase of bilateral squat
Time Frame
3 months after ACL reconstruction
Title
Cartilage T2 relaxation time
Description
Percent change in cartilage T2 relaxation time from 2 weeks to 6 months after ACL reconstruction
Time Frame
6 months after ACL reconstruction
Secondary Outcome Measure Information:
Title
Knee flexion moment impulse
Description
Between-limb ratio of knee flexion moment impulse during descent and ascent phase of bilateral squat
Time Frame
6 months after ACL reconstruction
Title
Peak knee flexion moment
Description
Between-limb ratio of peak flexion moment during gait
Time Frame
3 months after ACL reconstruction
Title
Peak knee flexion moment
Description
Between-limb ratio of peak flexion moment during gait
Time Frame
6 months after ACL reconstruction
Title
Cartilage T1rho relaxation time
Description
Percent change in cartilage T1rho relaxation time from 2 weeks to 6 months after ACL reconstruction
Time Frame
6 months after ACL reconstruction
Title
Quadriceps strength
Description
Between-limb ratio of isometric and isokinetic quadriceps strength
Time Frame
3 months after ACL reconstruction
Title
Quadriceps strength
Description
Between-limb ratio of isometric and isokinetic quadriceps strength
Time Frame
6 months after ACL reconstruction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute ACL injury in the past 6 months have had ACL reconstruction in the past month or have a planned ACL reconstruction Exclusion Criteria: previous knee injury or surgery (either knee) body mass index over 35 kg/m2 concomitant posterior cruciate ligament reconstruction or cartilage procedure that include extended weightbearing restrictions and/or changes to cartilage structure current pregnancy planned pregnancy during study duration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth A Wellsandt, DPT, PhD
Phone
402-559-4309
Email
elizabeth.wellsandt@unmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Barber, MS
Phone
402-863-9165
Email
robert.barber@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Wellsandt, DPT, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Wellsandt, DPT, PhD
Phone
402-559-4309
Email
elizabeth.wellsandt@unmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimizing Movement After ACL Injury

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