The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy

NCT03262181 | Completed

• 1 other identifier: 17-1731
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinopathy

Keywords

Exercise; Physical Activity; Biomechanics

Outcome Measures

Primary Outcomes (5)

• Difference in the change in mean internal knee extension moment during landing between groups

  Angular force or moment will be measured in Nm/kg\*m where "Nm" represents angular force and "kg\*m" represents normalization to body weight and height.

  Pre- and post-intervention condition (~30 minutes)

• Difference in the change in mean internal hip flexion moment during landing between groups

  Angular force or moment will be measured in Nm/kg\*m where "Nm" represents angular force and "kg\*m" represents normalization to body weight and height.

  Pre- and post-intervention condition (~30 minutes)

• Difference in the change in mean peak vertical ground reaction force during landing between groups

  Vertical ground reaction force will be measured in N(BW) where "N" is a measure of force and "BW" represents normalization to body weight.

  Pre- and post-intervention condition (~30 minutes)

• Difference in the change in mean peak vertical ground reaction force loading rate during landing between groups

  Vertical ground reaction force loading rate will be measured in N(BW)/s where "N" is a measure of force and "BW" represents normalization to body weight and "s" is the time unit seconds.

  Pre- and post-intervention condition (~30 minutes)

• Difference in the change in mean peak patellar tendon force during landing between groups

  Patellar tendon force will be measured in N(BW) where "N" is a measure of force and "BW" represents normalization to body weight.

  Pre- and post-intervention condition (~30 minutes)

Secondary Outcomes (3)

• Difference in average steps-per-day between groups

  Day 1 - Day 7

• Difference in average minutes of moderate-to-vigorous physical activity (MVPA) between groups

  Day 1 - Day 7

• Difference in change in anterior knee pain (self-reported via visual analog scale (0-10)) between groups

  Pre- and post-intervention condition (~10 minutes)

Study Arms (2)

Isometric Exercise Condition

EXPERIMENTAL

The participant will perform 5 sets of a 45-second isometric contractions at 70% of their maximum voluntary isometric contraction (MVIC). During the 45-second contraction, the participant will be provided with visual biofeedback on a computer screen (70% MVIC target line and +/- 5% error lines). The participant will be instructed to produce a level of isometric quadriceps contraction that maintains the isometric torque output line as close the target line as possible and always between the two error lines.

Other: Isometric Exercise

Sham TENS Condition

SHAM COMPARATOR

Two electrodes of the Select System TENS unit (Empi, Inc., St. Paul, MN) will be placed on either side of the patellar tendon on the test limb. The same instruction script will be used for each participant, stating, "A surface electrode has been placed on either side of your patellar tendon. I will turn on the stimulation unit to emit a stimulus to your patellar tendon. This is a special sub-sensory stimulation treatment, so you will not feel anything during this period as the stimulus is set at a very low, non-detectable threshold. Please remain still during this 45-second period, letting your leg rest passively in the machine without contracting your leg muscles. After the 45-second period, the stimulation unit will be turned off and you will have a 2-minute rest period. We will repeat this same treatment/rest sequence 5 total times."

Other: Sham Transcutaneous Electrical Nerve Stimulation

Interventions

Isometric Exercise OTHER

5 sets of 45-seconds quadriceps contraction, each followed by 2-minutes of rest.

Also known as: Therapeutic Exercise

Isometric Exercise Condition

Sham Transcutaneous Electrical Nerve Stimulation OTHER

5 sets of 45-seconds intervals without quadriceps contraction, each followed by 2-minutes of rest.

Also known as: Sham TENS

Sham TENS Condition

Eligibility Criteria

• Age: 15 Years - 28 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The investigators will recruit a convenience sample of participants who meet the following overall criteria:
• Age 15 and post-pubertal (confirmed by Pubertal Development Scale Questionnaire) - 28 years
• 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.

You may not qualify if:

• Any anterior knee pain with no patellar tendon abnormality on ultrasound assessment.
• History of any knee joint surgery ever.
• History of other (non-knee) lower extremity surgery in the last 1 year.
• History of lower extremity injury in last 6 months (other than patellar tendinopathy).
• An injection (corticosteroids, plasma-rich-protein, etc.) to the patellar tendon in the last 3 months.
• Known history of osteoarthritis or current symptoms related to osteoarthritis (i.e. stiffness, swelling).
• Participation in formal rehabilitation for patellar tendinopathy in prior 3 months
• 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.
• Use of pacemaker or another implantable electronic device.
• History of cardiac arrhythmia or any cardiac condition.
• History of psychiatric disorder. \*
• History of cancer in the brain or thigh musculature.
• Pubertal Development Scale Score \< 12 (Stages 1-4)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation for Physical Therapy, Inc.: collaborator

Study Sites (1)

Sports Medicine Research Laboratory

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Tendinopathy; Motor Activity

Interventions

Exercise; Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Darin A Padua, PhD, ATC

  Professor and Department Chair

  STUDY CHAIR

• Laura E Stanley, DPT

  Graduate Research Assistant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants are masked to their group assignment until the end of the study. Investigator is masked to intervention condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 25, 2017
• Study Start: September 15, 2017
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

US (1)