NCT05568784

Brief 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 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

September 30, 2022

Last Update Submit

February 19, 2024

Conditions

Quadriceps Muscle AtrophyLeg Injury

Outcome Measures

Primary Outcomes (1)

  • Noraxon Ultium EMG

    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

Study Arms (2)

Healthy Participants

Patients without pre-existing lower extremity injury that may inhibit response to testing

Other: Straight Leg Raise exercise

Participants with Knee Arthroscopy

Patients who have recently suffered knee injury that required arthroscopic surgery

Other: Straight Leg Raise exercise

Interventions

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)

Healthy ParticipantsParticipants with Knee Arthroscopy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Males and females ages 18-55

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32561, United States

RECRUITING

Related Publications (19)

  • 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.

    PMID: 24490843BACKGROUND

  • 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.

    PMID: 14656668BACKGROUND

  • 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.

    PMID: 15866968BACKGROUND

  • Suter 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.

    PMID: 11415802BACKGROUND

  • 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.

    PMID: 15491837BACKGROUND

  • 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.

    PMID: 20064053BACKGROUND

  • Hopkins J, Ingersoll CD. Arthrogenic muscle inhibition: A limiting factor in joint rehabilitation. Journal of Sport Rehabilitation. 2000;9(2):135-159.

    BACKGROUND

  • 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.

    PMID: 15685462BACKGROUND

  • 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.

    PMID: 18668174BACKGROUND

  • 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.

    PMID: 17244901BACKGROUND

  • Torry 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.

    PMID: 10656976BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 4426322BACKGROUND

  • Moore JC. Excitation overflow: an electromyographic investigation. Arch Phys Med Rehabil. 1975 Mar;56(3):115-20.

    PMID: 1119917BACKGROUND

  • 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.

    PMID: 11983436BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 21044725BACKGROUND

  • 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.

    PMID: 8156741BACKGROUND

  • 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.

    PMID: 21282869BACKGROUND

MeSH Terms

Conditions

Leg Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Tyler Opitz, PT, DPT

    Physical Therapist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chandler Bridges

CONTACT

8509168584chandler.bridges@andrewsref.org

Victora Williams

CONTACT

8509168487victoria.williams@andrewsref.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 6, 2022

Study Start

April 11, 2021

Primary Completion

April 3, 2024

Study Completion

July 3, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)