Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

ACL Tears Clinical Trial

Official title:

Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03132987
• Other study ID #: 928791
• Secondary ID: 5P20GM109090-03
• Status: Completed
• Phase: N/A
• First received: January 30, 2017
• Last updated: August 15, 2017
• Start date: January 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2017
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• ACL Tears

Intervention

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.

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (4)

Lead Sponsor	Collaborator
Creighton University	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), University of Nebraska, Omaha

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Knee Joint biomechanics during gait (traditional)	peak external knee flexion moment (Nm/kgm)	Change from Baseline knee joint biomechanics at 3 weeks
Secondary	Patient reported function	International Knee Documentation Committee (IKDC) subjective form	Change from Baseline IKDC at 3 weeks
Secondary	Jumping performance	single leg hop for distance (cm)	Change from Baseline single leg hop for distance at 3 weeks