Quadriceps Muscle AtrophySLRNCT05568784
Straight Leg Raise Continuation
An observational study of Quadriceps Muscle Atrophy and Leg Injury, run by Andrews Research & Education Foundation at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadriceps Muscle Atrophy, Leg Injury
- What is being tested?
- Straight Leg Raise exercise
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2021to 3 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consists of two groups of 50 individual participants each. These groups are healthy participants and participants who have recently undergone knee arthroplasty.
Who may be able to join
- Males and females ages 18-55
Who cannot join
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Andrews Research and Education Foundation
Gulf Breeze, Florida, 32561
Jessi Truett, 850-916-8570, jessica.truett@andrewsref.org
Chandler Bridges, 8509168584, chandler.bridges@andrewsref.org
About this study
Official title: 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
Read the 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.
- Conditions
- Quadriceps Muscle Atrophy, Leg Injury
- Being tested
- Straight Leg Raise exercise
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight Leg Raise exerciseOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Patients without pre-existing lower extremity injury that may inhibit response to testing Receives: Other: Straight Leg Raise exercise | |
| Participants with Knee Arthroscopy | Patients who have recently suffered knee injury that required arthroscopic surgery Receives: Other: Straight Leg Raise exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noraxon Ultium EMG
Visually monitors and records electromagnetic signals from muscle activation using diodes placed on patient
Measured: Within first 28 days post-op (Arthroscopy patients); healthy patients tested at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start11 Apr 2021
- Primary completion3 Apr 2024 (estimated)
- Study completion3 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Quadriceps Muscle AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Florida
- Responsible party
- Sponsor
- Investigators
- Tyler Opitz, PT, DPT, Principal investigator, Physical Therapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568784
- Sponsor's protocol ID
- SLR Continuation
- Acronym
- SLR
- Status last verified
- Feb 2024
- First submitted
- 30 Sep 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24490843Lewek 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.
PubMed 14656668Mizner 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.
PubMed 15866968Suter E, Herzog W, Bray RC. Quadriceps inhibition following arthroscopy in patients with anterior knee pain. Clin Biomech (Bristol). 1998 Jun;13(4-5):314-319. doi: 10.1016/s0268-0033(98)00098-9.
PubMed 11415802Palmieri 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.
PubMed 15491837Hart 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.
PubMed 20064053Hopkins J, Ingersoll CD. Arthrogenic muscle inhibition: A limiting factor in joint rehabilitation. Journal of Sport Rehabilitation. 2000;9(2):135-159.
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.
PubMed 15685462Pietrosimone 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.
PubMed 18668174Palmieri-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.
PubMed 17244901Torry MR, Decker MJ, Viola RW, O'Connor DD, Steadman JR. Intra-articular knee joint effusion induces quadriceps avoidance gait patterns. Clin Biomech (Bristol). 2000 Mar;15(3):147-59. doi: 10.1016/s0268-0033(99)00083-2.
PubMed 10656976Panariello 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.
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.
PubMed 4426322Moore JC. Excitation overflow: an electromyographic investigation. Arch Phys Med Rehabil. 1975 Mar;56(3):115-20.
PubMed 1119917Shimura 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.
PubMed 11983436
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadriceps Activation Comparative Analysis Based on Positioning of the Ankle During Supine Straight Leg Raise and Quad Set
- ClinicalTrials.gov ID
- NCT05568784
- Acronym / sponsor ID
- SLR / SLR Continuation
- Conditions
- Quadriceps Muscle Atrophy, Leg Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Collaborators
- Florida
- Study start
- 11 Apr 2021 (actual)
- Primary completion
- 3 Apr 2024 (estimated)
- Study completion
- 3 Jul 2024 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | – | Other: Straight Leg Raise exercisePatients without pre-existing lower extremity injury that may inhibit response to testing |
| Participants with Knee Arthroscopy | – | Other: Straight Leg Raise exercisePatients who have recently suffered knee injury that required arthroscopic surgery |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of two groups of 50 individual participants each. These groups are healthy participants and participants who have recently undergone knee arthroplasty.
Key inclusion criteria (1 listed)
- Males and females ages 18-55
Key exclusion criteria (5 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Straight Leg Raise exercisePatient 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) | Other | Healthy Participants, Participants with Knee Arthroscopy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Background: PubMed 24490843Harkey 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.
- Background: PubMed 14656668Lewek 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.
- Background: PubMed 15866968Mizner 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.
- Background: PubMed 11415802Suter E, Herzog W, Bray RC. Quadriceps inhibition following arthroscopy in patients with anterior knee pain. Clin Biomech (Bristol). 1998 Jun;13(4-5):314-319. doi: 10.1016/s0268-0033(98)00098-9.
- Background: PubMed 15491837Palmieri 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.
- Background: PubMed 20064053Hart 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.
- BackgroundHopkins J, Ingersoll CD. Arthrogenic muscle inhibition: A limiting factor in joint rehabilitation. Journal of Sport Rehabilitation. 2000;9(2):135-159.
- Background: PubMed 15685462Palmieri 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.
- Background: PubMed 18668174Pietrosimone 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.
- Background: PubMed 17244901Palmieri-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.
- Background: PubMed 10656976Torry MR, Decker MJ, Viola RW, O'Connor DD, Steadman JR. Intra-articular knee joint effusion induces quadriceps avoidance gait patterns. Clin Biomech (Bristol). 2000 Mar;15(3):147-59. doi: 10.1016/s0268-0033(99)00083-2.
- BackgroundPanariello 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.
- Individual participant dataSharing planned: No
Related trials for Quadriceps Muscle Atrophy
Recruiting
Effects of Different Stiffness Settings During Robotic Isokinetic Training in Children With SMA
Spinal Muscular Atrophy (SMA)
Not yet recruiting
Blood Flow Restriction Training in Knee Arthropathy
Knee Arthroscopic Surgery, Arthrogenic Muscle Inhibition
RecruitingObservational study
RELATIONSHIP BETWEEN ULTRASONOGRAPHIC QUADRICEPS MUSCLE THICKNESS AND SARCOPENIA MARKERS (HANDGRIP STRENGTH, SARC-F) AND KINESIOPHOBIA IN STROKE PATIENTS
Stroke, Sarcopenia
Not yet recruiting
Effect of Knee Position on Muscle Loss During Leg Immobilization
Muscle Atrophy, Disuse Atrophy
Not yet recruitingObservational study
Muscle Strength Asymmetry In Sarkopenic And Non-sarcopenic Older Adults
Sarcopenia in Elderly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler Opitz, PT, DPT principal investigator
Physical Therapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quadriceps Muscle Atrophy and Leg Injury, run by Andrews Research & Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chandler Bridges (8509168584, chandler.bridges@andrewsref.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noraxon Ultium EMG (time frame: Within first 28 days post-op (Arthroscopy patients); healthy patients tested at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05568784, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.