Effect of Electromyographic Biofeedback on Quadriceps Neuromuscular Function in Patients With Quadriceps Inhibition

NCT02095223 | Terminated Results

• 1 other identifier: 20130868
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle inhibition prevents optimal contraction of the quadriceps muscle due to changes in the nervous system after knee joint injury. Current treatments for muscle inhibition at this time include knee joint cryotherapy and electric stimulation prior to exercise. These treatments, in addition to strengthening exercises, have shown improvements in the quality and strength of muscle contractions however, they have a short window of effectiveness. Electromyographic Biofeedback is proven to be useful in improving quadriceps strength but the mechanism of action remains somewhat unclear. Therefore, the purpose of this investigation is to compare the effectiveness of electromyographic biofeedback supplemented exercise when compared to traditional exercise on quadriceps muscle function in individuals with a history of knee injury and current evidence of quadriceps inhibition. We hypothesize that 14 days of electromyographic biofeedback supplemented exercise will lead to larger gains in quadriceps activation when compared to traditional exercise. Thirty 18-40 year old participants with a history of knee injury and current evidence of quadriceps muscle inhibition will be enrolled in this single blind randomized controlled trial. Participants will provide written consent prior to all study procedures. Following enrollment, participants will be asked complete questionnaires related to knee related function, current levels of pain, and current activity level followed by completion of baseline measurements.

1. 1.We will use the superimposed burst technique to quadriceps muscle activation.
2. 2.We will measure the Hoffmann reflex response of the quadriceps with surface electromyography. We will measure this signal with surface electromyography electrodes that record the activity of the quadriceps muscle through the skin.

Conditions

Knee Injuries

Keywords

Knee injury; Meniscus injury; Anterior cruciate ligament injury; Knee ligament injury

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Quadriceps Central Activation Ratio

  Subjects will be secured to a chair (Biodex multi-mode dynamometer) with their knees and hips bent to approximately 90-degrees. Subjects will perform a maximal, voluntary isometric knee extension contraction (MVIC) with continuous verbal encouragement from the tester. Once the MVIC reaches a plateau (representing subjects' maximal effort) an electrical stimulus will be manually triggered and delivered directly to the quadriceps through 2 stimulating electrodes which will be secured to the subjects' anterior thigh. The stimulus will cause the quadriceps to twitch resulting in a temporary increase in force production which we will measure. A ratio between the MVIC force and the highest force achieved due to the electrical stimulation will be calculated - this is called the central activation ratio.

  Baseline and 14 days

Secondary Outcomes (1)

• Change From Baseline in Quadriceps Hoffmann Reflex

  Baseline and 14 days

Study Arms (2)

Electromyographic Biofeedback Group

EXPERIMENTAL

Participants in the electromyographic biofeedback supplemented exercise will be instructed on correct setup and use of the electromyographic biofeedback unit. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group. Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.

Device: Electromyographic Biofeedback; Behavioral: Traditional Exercise

Traditional Exercise Group

ACTIVE COMPARATOR

Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.

Behavioral: Traditional Exercise

Interventions

Electromyographic Biofeedback DEVICE

Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.

Also known as: Device Name: MyoTrac Biofeedback Unit, System#: SA4000P/SA4001P, System Name: Myotrac EMG Biofeedback System

Electromyographic Biofeedback Group

Traditional Exercise BEHAVIORAL

All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.

Electromyographic Biofeedback Group; Traditional Exercise Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• History of primary and uncomplicated knee injury or knee surgery.
• Aged 18-40
• Quadriceps Central Activation Ratio is less than 90%

You may not qualify if:

• Currently seeking physical therapy
• Complex knee injury
• Surgical revisions to original procedure
• Pain greater than 4 out of 10 on a visual analog scale at enrollment.
• Active infection
• Current pregnancy
• Cognitive impairment
• Psychiatric disorder requiring daily medication
• Chronic or acute neuropathy
• Known muscular abnormalities
• History of neurological disorders
• History or family history of seizures and/or epilepsy and/or on medications that lower seizure threshold

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Department of Kinesiology and Sport Sciences, University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (3)

• Ng GY, Zhang AQ, Li CK. Biofeedback exercise improved the EMG activity ratio of the medial and lateral vasti muscles in subjects with patellofemoral pain syndrome. J Electromyogr Kinesiol. 2008 Feb;18(1):128-33. doi: 10.1016/j.jelekin.2006.08.010. Epub 2006 Oct 27.

  PMID: 17070701 BACKGROUND

• Oravitan M, Avram C. The effectiveness of electromyographic biofeedback as part of a meniscal repair rehabilitation programme. J Sports Sci Med. 2013 Sep 1;12(3):526-32. eCollection 2013.

  PMID: 24149161 BACKGROUND

• Christanell F, Hoser C, Huber R, Fink C, Luomajoki H. The influence of electromyographic biofeedback therapy on knee extension following anterior cruciate ligament reconstruction: a randomized controlled trial. Sports Med Arthrosc Rehabil Ther Technol. 2012 Nov 6;4(1):41. doi: 10.1186/1758-2555-4-41.

  PMID: 23126601 BACKGROUND

MeSH Terms

Conditions

Knee Injuries; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Christopher Kuenze
• Organization: University of Miami

kuenzech@msu.edu

5174325018

Study Officials

• Christopher Kuenze, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 24, 2014
• Study Start: December 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 1, 2017
• Results First Posted: August 30, 2016

Record last verified: 2016-12

Locations

US (1)