Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

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

Study Overview

• Status: Completed
• Conditions: ACL Tears
• Intervention / Treatment: Other: Progressive strengthening program

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • Creighton University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Progressive strengthening program; 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.	Other: Progressive strengthening program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps Rate of Torque Development (RTD) Maximum	slope of the torque-time tracing (change in torque/change in time) (Nm/kg*s-1)	Change from Baseline Quadriceps RTD at 3 weeks
Knee Joint biomechanics during gait (nonlinear)	Sagittal plane (knee flexion) movement variability (calculated using Lyapunov Exponent and approximate entropy)	Change from Baseline nonlinear knee joint biomechanics at 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps percent activation	Supramaximal electrical stimulus (interpolated twitch technique) used to augment a voluntary muscle contraction	Change from Baseline Quadriceps percent activation at 3 weeks
Knee Joint biomechanics during gait (traditional)	peak external knee flexion moment (Nm/kgm)	Change from Baseline knee joint biomechanics at 3 weeks
Patient reported function	International Knee Documentation Committee (IKDC) subjective form	Change from Baseline IKDC at 3 weeks
Jumping performance	single leg hop for distance (cm)	Change from Baseline single leg hop for distance at 3 weeks

Collaborators and Investigators

• Sponsor: Creighton University
• Collaborators: National Institutes of Health (NIH); National Institute of General Medical Sciences (NIGMS); University of Nebraska

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): July 31, 2017
• Study Completion (ACTUAL): July 31, 2017

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): April 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: quadriceps strength; quadriceps voluntary activation; progressive strength program
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 928791; 5P20GM109090-03 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO