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Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

Primary Purpose

ACL Tears

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive strengthening program
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Tears focused on measuring quadriceps strength, quadriceps voluntary activation, progressive strength program

Eligibility Criteria

14 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physically active
  • History of primary unilateral ACL reconstruction within the past 3-24 months (ACL group only)

Exclusion Criteria:

  • History of lumbar spine or lower extremity injury or surgery (except ACL) within the past 1 year that required physician care
  • Concomitant knee injury (ACL group only): ligament injury that requires surgical repair (medial collateral ligament [MCL], posterior cruciate ligament[PCL]), chondral defects >2cm, fracture, bilateral knee injury
  • Medial conditions that are contraindications to electrical stimulation: Cardiac Pacemaker and Pregnancy
  • Participants who are unable to understand procedures of experiment or provide consent (assent/parental permission)

Sites / Locations

  • Creighton University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Progressive strengthening program

Arm Description

Subjects identified as having a clinically relevant strength deficit will be asked to participate in physical therapy sessions 3 times per week for 3 weeks. The strengthening program will consist of an individualized, progressive exercise program with an emphasis on increasing lower extremity strength, power, and biomechanics.

Outcomes

Primary Outcome Measures

Quadriceps Rate of Torque Development (RTD) Maximum
slope of the torque-time tracing (change in torque/change in time) (Nm/kg*s-1)
Knee Joint biomechanics during gait (nonlinear)
Sagittal plane (knee flexion) movement variability (calculated using Lyapunov Exponent and approximate entropy)

Secondary Outcome Measures

Quadriceps percent activation
Supramaximal electrical stimulus (interpolated twitch technique) used to augment a voluntary muscle contraction
Knee Joint biomechanics during gait (traditional)
peak external knee flexion moment (Nm/kgm)
Patient reported function
International Knee Documentation Committee (IKDC) subjective form
Jumping performance
single leg hop for distance (cm)

Full Information

First Posted
January 30, 2017
Last Updated
August 15, 2017
Sponsor
Creighton University
Collaborators
University of Nebraska, National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03132987
Brief Title
Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction
Official Title
Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
Collaborators
University of Nebraska, National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Quantify differences in quadriceps function and gait biomechanics in individuals within 2 years of ACL reconstruction compared to a healthy comparison group and establish the feasibility of conducting a progressive strengthening program to improve clinical and patient-oriented outcomes in individuals who are within 2 years of ACL reconstruction
Detailed Description
A maximal isometric muscle contraction of the quadriceps will be used to examine neural and peripheral contributions to quadriceps strength. Neural influences will be quantified using the interpolated twitch technique (voluntary activation) and early RTD. Peripheral influences will be quantified by examining the stimulus-evoked torque with the quadriceps relaxed (resting twitch) and late RTD. Knee joint biomechanics during treadmill walking and running will include sagittal plane (flexion, extension) movement variability (Lyapunov Exponent and approximate entropy), peak knee flexion angle, and peak external knee flexion and adduction moments. Additionally, the clinical relevance of impairments in the ACL reconstruction group will be determined by examining the relationship with performance on jumping tasks and patient function (secondary outcomes). The progressive strengthening program will be performed for 6 weeks and emphasize development of strength and power. Feasibility will be established if the researchers can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. The researchers will determine effect sizes for changes outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Tears
Keywords
quadriceps strength, quadriceps voluntary activation, progressive strength program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Physical therapy exercises (progressive strengthening program)
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive strengthening program
Arm Type
Experimental
Arm Description
Subjects identified as having a clinically relevant strength deficit will be asked to participate in physical therapy sessions 3 times per week for 3 weeks. The strengthening program will consist of an individualized, progressive exercise program with an emphasis on increasing lower extremity strength, power, and biomechanics.
Intervention Type
Other
Intervention Name(s)
Progressive strengthening program
Intervention Description
The progressive strengthening program will be performed for 3 weeks and emphasize development of strength and power. Feasibility will be established if we can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. We will determine effect sizes for changes outcome measures.
Primary Outcome Measure Information:
Title
Quadriceps Rate of Torque Development (RTD) Maximum
Description
slope of the torque-time tracing (change in torque/change in time) (Nm/kg*s-1)
Time Frame
Change from Baseline Quadriceps RTD at 3 weeks
Title
Knee Joint biomechanics during gait (nonlinear)
Description
Sagittal plane (knee flexion) movement variability (calculated using Lyapunov Exponent and approximate entropy)
Time Frame
Change from Baseline nonlinear knee joint biomechanics at 3 weeks
Secondary Outcome Measure Information:
Title
Quadriceps percent activation
Description
Supramaximal electrical stimulus (interpolated twitch technique) used to augment a voluntary muscle contraction
Time Frame
Change from Baseline Quadriceps percent activation at 3 weeks
Title
Knee Joint biomechanics during gait (traditional)
Description
peak external knee flexion moment (Nm/kgm)
Time Frame
Change from Baseline knee joint biomechanics at 3 weeks
Title
Patient reported function
Description
International Knee Documentation Committee (IKDC) subjective form
Time Frame
Change from Baseline IKDC at 3 weeks
Title
Jumping performance
Description
single leg hop for distance (cm)
Time Frame
Change from Baseline single leg hop for distance at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physically active History of primary unilateral ACL reconstruction within the past 3-24 months (ACL group only) Exclusion Criteria: History of lumbar spine or lower extremity injury or surgery (except ACL) within the past 1 year that required physician care Concomitant knee injury (ACL group only): ligament injury that requires surgical repair (medial collateral ligament [MCL], posterior cruciate ligament[PCL]), chondral defects >2cm, fracture, bilateral knee injury Medial conditions that are contraindications to electrical stimulation: Cardiac Pacemaker and Pregnancy Participants who are unable to understand procedures of experiment or provide consent (assent/parental permission)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry L Grindstaff, PhD, PT, ATC
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

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