Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction

NCT03132987 | Completed

• 2 other identifiers: 9287915P20GM109090-03
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

ACL Tears

Keywords

quadriceps strength; quadriceps voluntary activation; progressive strength program

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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 Arms (1)

Progressive strengthening program

EXPERIMENTAL

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

Interventions

Progressive strengthening program 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.

Progressive strengthening program

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Creighton University: lead
• University of Nebraska: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Terry L Grindstaff, PhD, PT, ATC

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Physical therapy exercises (progressive strengthening program)

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: April 28, 2017
• Study Start: January 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)