Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

NCT ID: NCT03132987

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-07-31

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.

Conditions

ACL Tears

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Progressive strengthening program

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terry L Grindstaff, PhD, PT, ATC

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Creighton University

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

5P20GM109090-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

928791

Identifier Type: -

Identifier Source: org_study_id