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Clinical Trials/NCT03132987
NCT03132987
Completed
Not Applicable

Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

Creighton University1 site in 1 country39 target enrollmentJanuary 2017
ConditionsACL Tears

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ACL Tears
Sponsor
Creighton University
Enrollment
39
Locations
1
Primary Endpoint
Quadriceps Rate of Torque Development (RTD) Maximum
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
July 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Quadriceps Rate of Torque Development (RTD) Maximum

Time Frame: Change from Baseline Quadriceps RTD at 3 weeks

slope of the torque-time tracing (change in torque/change in time) (Nm/kg\*s-1)

Knee Joint biomechanics during gait (nonlinear)

Time Frame: Change from Baseline nonlinear knee joint biomechanics at 3 weeks

Sagittal plane (knee flexion) movement variability (calculated using Lyapunov Exponent and approximate entropy)

Secondary Outcomes

  • Quadriceps percent activation(Change from Baseline Quadriceps percent activation at 3 weeks)
  • Knee Joint biomechanics during gait (traditional)(Change from Baseline knee joint biomechanics at 3 weeks)
  • Patient reported function(Change from Baseline IKDC at 3 weeks)
  • Jumping performance(Change from Baseline single leg hop for distance at 3 weeks)

Study Sites (1)

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