- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05568784
Straight Leg Raise Continuation (SLR)
Quadriceps Activation Comparative Analysis Based on Positioning of the Ankle During Supine Straight Leg Raise and Quad Set
The goal of this study is to compare quadriceps muscle activation in patients recovering from lower extremity injury, such as an ACL tear. Specifically, the main objectives are as follows:
- Determine the effects of ankle positioning on quad muscle activation during straight leg raise exercises performed while the patient is lying on his or her back
- Determine if there is a difference between ankle positioning on quad muscle activation during straight leg raise exercises performed while the patient is lying on his or her back, comparing healthy versus post-operative participants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Returning quadriceps neuromuscular control and preventing atrophy is an area of intense current interest in orthopedic rehabilitation and recovery science. It is clear that returning full autonomous control of the quadriceps, including the vastus medialis obliqus (VMO), at full knee extension is an important factor in rehab and dysfunction of the quadriceps leads to a loss of physical performance and self-reported function. Quadriceps function is critical for optimal ambulation patterns and eccentric control is essential for the weight acceptance phase of gait.
Quadriceps atrophy is one of the most common post-operative side effects of anterior cruciate ligament (ACL) reconstruction, total knee arthroplasty, and many other surgeries including meniscal repairs, patella realignment procedures, and microfracture procedures. Due to the swelling within the joint after injury or surgery to the knee, the joint inflammation cascade occurs and leads to the quadriceps being arthrogenically inhibited by spinal neuron inhibition as a protective mechanism. These neural changes usually lead to decreased voluntary quadriceps contraction. Additional contributions of inhibition from post-operative pain, patient apprehension, and surgical procedure requiring protection of the repaired tissue. The sooner one regains control of the quadriceps muscles the less atrophy occurs, reductions in strength are minimized, and the more optimal the outcome is achieved for patient recovery.
Studies have shown that neuromuscular electrical stimulation (NMES), Transcutaneous electrical nerve stimulation (TENS), and biofeedback techniques can limit post-operative quadriceps atrophy and can return strength of the quadriceps back to normative values faster than without those techniques and traditional therapeutic exercise and have better long-term outcomes based on pain, functional outcomes, and return to sport participation rates.
Irradiation effect is a proprioceptive neuromuscular facilitation technique that causes an overflow of neuronal energy from distal to proximal muscles to increase muscle activity of a targeted muscle. This technique can be used to selectively recruit weaker motor units through the application of resistance or stimulation. By inducing a stronger contractile force of the quadriceps, our hope is to return quadriceps function to normal quicker with less atrophy and greater strength.
The investigators hypothesize that ankle positioning in maximal dorsiflexion (DF) changes the quantity of contraction as a percent of the reference voluntary contraction when performing a supine straight leg raise compared with having the foot in neutral (0°), relaxed, and plantarflexed (PF) positions. This may help provide insight into proper instruction and cuing for patients to return quadriceps neuromuscular control sooner and thus limiting quadriceps atrophy.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chandler Bridges
- Phone Number: 8509168584
- Email: chandler.bridges@andrewsref.org
Study Contact Backup
- Name: Victora Williams
- Phone Number: 8509168487
- Email: victoria.williams@andrewsref.org
Study Locations
-
-
Florida
-
Gulf Breeze, Florida, United States, 32561
- Recruiting
- Andrews Research and Education Foundation
-
Contact:
- Chandler Bridges
- Phone Number: 8509168584
- Email: chandler.bridges@andrewsref.org
-
Contact:
- Jessi Truett
- Phone Number: 850-916-8570
- Email: jessica.truett@andrewsref.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
(All Participants)
Inclusion Criteria:
- Males and females ages 18-55
Exclusion Criteria:
- History of diagnosed cancer, neurological disorder, peripheral nerve injury affecting the lower limb or injury to the lower spine with radicular symptoms, which may affect quadriceps activation
- History of musculoskeletal injury to the quadriceps that may affect ability to maintain muscle contractions without excessive fatigue or discomfort
(Healthy Participants)
Exclusion Criteria:
- Injury to the knee or quadriceps muscle group within the past 12 months to the tested side
- History of lower extremity orthopedic surgery in the past 12 months to the tested side
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy Participants
Patients without pre-existing lower extremity injury that may inhibit response to testing
|
Patient lying supine will lift leg to the height of the contralateral knee flexed to 90 degrees with the ankle positioned and tested in all three positions (dorsiflexion, neutral, and plantarflexion)
|
|
Participants with Knee Arthroscopy
Patients who have recently suffered knee injury that required arthroscopic surgery
|
Patient lying supine will lift leg to the height of the contralateral knee flexed to 90 degrees with the ankle positioned and tested in all three positions (dorsiflexion, neutral, and plantarflexion)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Noraxon Ultium EMG
Time Frame: Within first 28 days post-op (Arthroscopy patients); healthy patients tested at enrollment
|
Visually monitors and records electromagnetic signals from muscle activation using diodes placed on patient
|
Within first 28 days post-op (Arthroscopy patients); healthy patients tested at enrollment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tyler Opitz, PT, DPT, Physical Therapist
Publications and helpful links
General Publications
- Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
- Harkey MS, Gribble PA, Pietrosimone BG. Disinhibitory interventions and voluntary quadriceps activation: a systematic review. J Athl Train. 2014 May-Jun;49(3):411-21. doi: 10.4085/1062-6050-49.1.04. Epub 2014 Feb 3.
- Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.
- Palmieri RM, Tom JA, Edwards JE, Weltman A, Saliba EN, Mistry DJ, Ingersoll CD. Arthrogenic muscle response induced by an experimental knee joint effusion is mediated by pre- and post-synaptic spinal mechanisms. J Electromyogr Kinesiol. 2004 Dec;14(6):631-40. doi: 10.1016/j.jelekin.2004.06.002.
- Hopkins J, Ingersoll CD. Arthrogenic muscle inhibition: A limiting factor in joint rehabilitation. Journal of Sport Rehabilitation. 2000;9(2):135-159.
- Panariello RA, Stump TJ, Allen AA. Rehabilitation and Return to Play Following Anterior Cruciate Ligament Reconstruction. Operative Techniques in Sports Medicine. 2017;25(3):181-193.
- Moore JC. Excitation overflow: an electromyographic investigation. Arch Phys Med Rehabil. 1975 Mar;56(3):115-20.
- Shimura K, Kasai T. Effects of proprioceptive neuromuscular facilitation on the initiation of voluntary movement and motor evoked potentials in upper limb muscles. Hum Mov Sci. 2002 Apr;21(1):101-13. doi: 10.1016/s0167-9457(01)00057-4.
- Choi SA, Cynn HS, Yoon TL, Choi WJ, Lee JH. Effects of Ankle Dorsiflexion on Vastus Medialis Oblique and Vastus Lateralis Muscle Activity During Straight Leg Raise Exercise with Hip External Rotation in Patellofemoral Pain Syndrome. Journal of Musculoskeletal Pain. 2014;22(3):260-267.
- Pietrosimone BG, Saliba SA, Hart JM, Hertel J, Kerrigan DC, Ingersoll CD. Effects of transcutaneous electrical nerve stimulation and therapeutic exercise on quadriceps activation in people with tibiofemoral osteoarthritis. J Orthop Sports Phys Ther. 2011 Jan;41(1):4-12. doi: 10.2519/jospt.2011.3447. Epub 2010 Dec 31.
- Lewek MD, Rudolph KS, Snyder-Mackler L. Quadriceps femoris muscle weakness and activation failure in patients with symptomatic knee osteoarthritis. J Orthop Res. 2004 Jan;22(1):110-5. doi: 10.1016/S0736-0266(03)00154-2.
- Suter E, Herzog W, Bray RC. Quadriceps inhibition following arthroscopy in patients with anterior knee pain. Clin Biomech (Bristol, Avon). 1998 Jun;13(4-5):314-319. doi: 10.1016/s0268-0033(98)00098-9.
- Hart JM, Pietrosimone B, Hertel J, Ingersoll CD. Quadriceps activation following knee injuries: a systematic review. J Athl Train. 2010 Jan-Feb;45(1):87-97. doi: 10.4085/1062-6050-45.1.87.
- Palmieri RM, Weltman A, Edwards JE, Tom JA, Saliba EN, Mistry DJ, Ingersoll CD. Pre-synaptic modulation of quadriceps arthrogenic muscle inhibition. Knee Surg Sports Traumatol Arthrosc. 2005 Jul;13(5):370-6. doi: 10.1007/s00167-004-0547-z. Epub 2005 Feb 1.
- Pietrosimone BG, Grindstaff TL, Linens SW, Uczekaj E, Hertel J. A systematic review of prophylactic braces in the prevention of knee ligament injuries in collegiate football players. J Athl Train. 2008 Jul-Aug;43(4):409-15. doi: 10.4085/1062-6050-43.4.409.
- Palmieri-Smith RM, Kreinbrink J, Ashton-Miller JA, Wojtys EM. Quadriceps inhibition induced by an experimental knee joint effusion affects knee joint mechanics during a single-legged drop landing. Am J Sports Med. 2007 Aug;35(8):1269-75. doi: 10.1177/0363546506296417. Epub 2007 Jan 23.
- Torry MR, Decker MJ, Viola RW, O'Connor DD, Steadman JR. Intra-articular knee joint effusion induces quadriceps avoidance gait patterns. Clin Biomech (Bristol, Avon). 2000 Mar;15(3):147-59. doi: 10.1016/s0268-0033(99)00083-2.
- Hopf HC, Schlegel HJ, Lowitzsch K. Irradiation of voluntary activity to the contralateral side in movements of normal subjects and patients with central motor disturbances. Eur Neurol. 1974;12(3):142-7. doi: 10.1159/000114613. No abstract available.
- Hurley MV, Jones DW, Newham DJ. Arthrogenic quadriceps inhibition and rehabilitation of patients with extensive traumatic knee injuries. Clin Sci (Lond). 1994 Mar;86(3):305-10. doi: 10.1042/cs0860305. Erratum In: Clin Sci 1994 Jun;86(6):xxii.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLR Continuation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quadriceps Muscle Atrophy
-
Umm Al-Qura UniversityUnknownQuadriceps Muscle Atrophy | Quadriceps Tendon Rupture | Quadriceps Strained TendonSaudi Arabia
-
University of JazanCompletedQuadriceps Muscle AtrophySaudi Arabia
-
Robert WestermannWithdrawnMuscle Atrophy | ACL Tear | Quadriceps Muscle Atrophy | Muscle Atrophy, ProximalUnited States
-
Istanbul UniversityRecruitingEMG | Quadriceps Muscle Atrophy | TourniquetTurkey
-
Groupe Hospitalier du HavreCompletedICU Acquired Weakness | Quadriceps Muscle AtrophyFrance
-
Connecticut Children's Medical CenterUniversity of ConnecticutRecruitingAnterior Cruciate Ligament Injuries | Knee Injuries | Quadriceps Muscle AtrophyUnited States
-
Lance BollingerNational Aeronautics and Space Administration (NASA)CompletedMuscle Weakness | Sleep Disturbance | Quadriceps Muscle AtrophyUnited States
-
Hacettepe UniversityCompletedAnterior Cruciate Ligament Rupture | Quadriceps Muscle AtrophyTurkey
-
Chinese University of Hong KongRecruitingAnterior Cruciate Ligament Injuries | Quadriceps Muscle AtrophyHong Kong
-
University of VirginiaCompletedAnterior Cruciate Ligament Injuries | Quadriceps Muscle AtrophyUnited States
Clinical Trials on Straight Leg Raise exercise
-
Alessandro HaupenthalSanta Catarina Federal UniversityUnknown
-
University of MilanMedical University of Vienna; Ohio State University; University of Campania "Luigi... and other collaboratorsRecruitingGastroesophageal RefluxItaly
-
Riphah International UniversityCompletedLumbar RadiculopathyPakistan
-
Riphah International UniversityCompletedPelvic Girdle PainPakistan
-
University of Medicine and Dentistry of New JerseyTerminatedLow Back PainUnited States
-
Kahramanmaras Sutcu Imam UniversityCompletedHamstring ShortnessTurkey
-
Sahreen AnwarRecruiting
-
Riphah International UniversityCompletedWeakness, Muscle | SIJ - Sprain of Sacroiliac Joint | Tightness of Back MusclesPakistan
-
Carroll UniversityRecruitingPhysical Activity | Abdominal Muscles | Postpartum | Pelvic Floor Dysfunctions | Neuromuscular AdaptationsUnited States
-
Universitat Internacional de CatalunyaCompletedMuscle StretchingSpain