Clinical trial NCT03132987: Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction
Official title: Characterizing Clinical and Biomechanical Contributions to Function Following ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Tears
Keywords: quadriceps strength
quadriceps voluntary activation
progressive strength program
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: University of Nebraska
name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2017-04-28
Enrollment: 39
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Physical therapy exercises (progressive strengthening program)
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Quadriceps Rate of Torque Development (RTD) Maximum
timeFrame: Change from Baseline Quadriceps RTD at 3 weeks
measure: Knee Joint biomechanics during gait (nonlinear)
timeFrame: Change from Baseline nonlinear knee joint biomechanics at 3 weeks
Secondary outcomes:
measure: Quadriceps percent activation
timeFrame: Change from Baseline Quadriceps percent activation at 3 weeks
measure: Knee Joint biomechanics during gait (traditional)
timeFrame: Change from Baseline knee joint biomechanics at 3 weeks
measure: Patient reported function
timeFrame: Change from Baseline IKDC at 3 weeks
measure: Jumping performance
timeFrame: Change from Baseline single leg hop for distance at 3 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Terry L Grindstaff, PhD, PT, ATC
role: PRINCIPAL_INVESTIGATOR
References: