Clinical trial NCT03262181: The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy
Official title: The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Keywords: Exercise
Physical Activity
Biomechanics
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
First posted: 2017-08-25
Enrollment: 43
Sex: MALE
Minimum age (years): 15
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine differences in lower extremity landing biomechanics and real-world physical activity between individuals with patellar tendinopathy compared to individuals without patellar tendinopathy,and to determine the acute effects of an isometric loading intervention on lower extremity landing biomechanics in individuals with patellar tendinopathy.


Eligibility criteria: Inclusion Criteria:

The investigators will recruit a convenience sample of participants who meet the following overall criteria:

1. Age 15 and post-pubertal (confirmed by Pubertal Development Scale Questionnaire) - 28 years
2. Actively participating within an organized sport setting (high school, collegiate, club, competitive intramural sports) in their respective team's weekly training and competitions, quantified by a Tegner Activity Level Scale of at least 5.

Exclusion Criteria:

The following exclusion criteria will be applied to all participants:

1. Any anterior knee pain with no patellar tendon abnormality on ultrasound assessment.
2. History of any knee joint surgery ever.
3. History of other (non-knee) lower extremity surgery in the last 1 year.
4. History of lower extremity injury in last 6 months (other than patellar tendinopathy).
5. An injection (corticosteroids, plasma-rich-protein, etc.) to the patellar tendon in the last 3 months.
6. Known history of osteoarthritis or current symptoms related to osteoarthritis (i.e. stiffness, swelling).
7. Participation in formal rehabilitation for patellar tendinopathy in prior 3 months
8. Known neurological disorders, including: stroke, multiple sclerosis, ALS, diabetic neuropathy, epilepsy, traumatic brain injury resulting in loss of consciousness, concussion within the last 6 months, cranial neural surgery, balance disorders.
9. Use of pacemaker or another implantable electronic device.
10. History of cardiac arrhythmia or any cardiac condition.
11. History of psychiatric disorder. \*
12. History of cancer in the brain or thigh musculature.
13. Pubertal Development Scale Score \< 12 (Stages 1-4)

    * Note: Rationale for exclusion of individuals with a history of psychiatric disorders is that these individuals may have taken or be taking pharmacological agents that could affect pain or neuromuscular control.

Primary outcomes:
measure: Difference in the change in mean internal knee extension moment during landing between groups
timeFrame: Pre- and post-intervention condition (~30 minutes)
measure: Difference in the change in mean internal hip flexion moment during landing between groups
timeFrame: Pre- and post-intervention condition (~30 minutes)
measure: Difference in the change in mean peak vertical ground reaction force during landing between groups
timeFrame: Pre- and post-intervention condition (~30 minutes)
measure: Difference in the change in mean peak vertical ground reaction force loading rate during landing between groups
timeFrame: Pre- and post-intervention condition (~30 minutes)
measure: Difference in the change in mean peak patellar tendon force during landing between groups
timeFrame: Pre- and post-intervention condition (~30 minutes)
Secondary outcomes:
measure: Difference in average steps-per-day between groups
timeFrame: Day 1 - Day 7
measure: Difference in average minutes of moderate-to-vigorous physical activity (MVPA) between groups
timeFrame: Day 1 - Day 7
measure: Difference in change in anterior knee pain (self-reported via visual analog scale (0-10)) between groups
timeFrame: Pre- and post-intervention condition (~10 minutes)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Sports Medicine Research Laboratory
state: North Carolina
Study officials:
affiliation: Professor and Department Chair
name: Darin A Padua, PhD, ATC
role: STUDY_CHAIR
affiliation: Graduate Research Assistant
name: Laura E Stanley, DPT
role: PRINCIPAL_INVESTIGATOR
References: