Angles of Knee and Hip Joints for Optimization of Neuromuscular Electrical Stimulation of the Quadriceps Femoris Muscle

NCT03822221 | Completed DMC

• 1 other identifier: CAAE: 94388718.8.0000.8093
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The muscle contractile effectiveness is influenced by the neural activation of the motor units, as well as its architecture and the elasticity of the myotendinous junction. In addition, tendinous properties also affect the production of muscle strength and function. Neuromuscular electrical stimulation (NMES) is a wide-used tool in rehabilitation for motor relearning, to reduce muscular atrophy, pain control and to improve functional performance. Although studies have demonstrated the efficacy of NMES in various clinical situations, the best joint angle (ideal muscle length) to enhance neuromuscular and tendinous adaptations induced by NMES has to be determined. Objective: To investigate the effect of NMES on different hip and knee angles on knee extensor torque, quadriceps muscle electromyographic activity, architecture, and tendon-aponeurosis complex elongation, and tendinous properties of the patellar tendon. Material and Methods: This is a crossover study with healthy males, aged 18-35 years. The independent variables will be: 1) NMES in different lower limb positions: knee joint angulation at 20º or 60º with hip at 0º or 80º (four combinations). The dependent variables will be: knee extensor torque, surface muscle electrical activity, muscle architecture (muscle thickness, pennation angle and fascicular length), the elongation of the tendon-aponeurosis complex of the quadriceps muscle components, and the properties (stiffness, Young's modulus and cross-sectional area) of the patellar tendon. The descriptive and analytical statistics will be carried out with measures of central tendency and dispersion, inference tests, tables and graphs. The normality of the data will be verified with the Shapiro-Wilk test. For the data that present normal distribution, the Two-Way ANOVA will be applied to verify differences among the measurements, with post-hoc of Bonferroni. The non-parametric option will be the Friedman test. Correlation coefficients will be calculated using the Pearson (parametric) or Spearman (non-parametric) correlation test. The level of statistical significance will be p \<0.05. Expected results: The effect of an NMES session on the neural, muscular and tendon adaptations related to the angular specificity of the hip and knee, indicating greater potential for strength and muscle mass gains, will be shown, which is fundamental in the prescription of electrostimulation in rehabilitation.

Conditions

Electrical Stimulation

Keywords

Quadriceps muscle; Electrical Stimulation; Patellar Tendon; Ultrasonography; Electromyography

Outcome Measures

Primary Outcomes (8)

• Dynamometry: Isometric evoked torque

  Torque generated in a dynamometer during neuromuscular electrical stimulation of the quadriceps femoris muscle.

  The peak torque of a seven-second contraction assessed in four different lower limb positions.

• Dynamometry: Maximal Voluntary Isometric Contraction

  Torque generated in a dynamometer during maximal voluntary isometric contraction of the quadriceps femoris muscle.

  The peak torque of a seven-second contraction assessed in four different lower limb positions.

• Ultrasonography: Muscle Thickness

  Thickness of each component of the quadriceps muscle assessed by ultrasonography both in rest and during voluntary and evoked contraction.

  Change from rest to the end of a seven-second ramp contraction.

• Ultrasonography: Pennation angle

  Ultrasonography will be used to assess the Angle formed by the fascicles and the deep aponeurosis in which they insert both in rest and during voluntary and evoked contraction.

  Change from rest to the end of a seven-second ramp contraction.

• Ultrasonography: Fascicle length

  Ultrasonography will be used to assess the fascicle length both in rest and during voluntary and evoked contraction.

  Change from rest to the end of a seven-second ramp contraction.

• Ultrasonography: Tendon-aponeurosis complex elongation

  Ultrasonography will be used to assess the tendon-aponeurosis complex elongation of each component of the quadriceps muscle from rest to maximal voluntary and evoked contraction.

  Change from rest to the end of a seven-second ramp contraction.

• Ultrasonography: Patellar tendon properties

  Variables assessed from the elongation of the patellar tendon during maximal voluntary and evoked contraction.

  Change from rest to the end of a seven-second ramp contraction.

• Surface electromyography

  Electromyographic activity of each superficial component of the quadriceps muscle both in rest and during voluntary.

  Change from rest to the end of a seven-second ramp contraction.

Secondary Outcomes (2)

• Maximal tolerated intensity

  The mean of the 12 repetitions in each session (1 per week, total of 4 sessions).

• Muscle fatigue

  The mean of 3 repetitions in the beginning and in the end of each session (1 per week, total of 4 sessions).

Study Arms (4)

SK20º

EXPERIMENTAL

MVIC and NMES with hip at 85º and knee at 20º

Other: MVIC and NMES with hip at 85º and knee at 20º

SK60º

EXPERIMENTAL

MVIC and NMES with hip at 85º and knee at 60º

Other: MVIC and NMES with hip at 85º and knee at 60º

LK20º

EXPERIMENTAL

MVIC and NMES with hip at 0º and knee at 20º

Other: MVIC and NMES with hip at 0º and knee at 20º

LK60º

EXPERIMENTAL

MVIC and NMES with hip at 0º and knee at 60º

Other: MVIC and NMES with hip at 0º and knee at 60º

Interventions

MVIC and NMES with hip at 85º and knee at 20º OTHER

With hip joint at 85º (seated) and knee at 20º (SK20º), subjects will be submitted to maximal isometric voluntary contractions (15-18 per session) and to contractions evoked by neuromuscular electrical stimulation (15-18 per session).

SK20º

MVIC and NMES with hip at 85º and knee at 60º OTHER

With hip joint at 85º (seated) and knee at 60º (SK60º), subjects will be submitted to maximal isometric voluntary contractions (15-18 per session) and to contractions evoked by neuromuscular electrical stimulation (15-18 per session).

SK60º

MVIC and NMES with hip at 0º and knee at 20º OTHER

With hip joint at 0º (lying) and knee at 20º (LK20º), subjects will be submitted to maximal isometric voluntary contractions (15-18 per session) and to contractions evoked by neuromuscular electrical stimulation (15-18 per session).

LK20º

MVIC and NMES with hip at 0º and knee at 60º OTHER

With hip joint at 0º (lying down) and knee at 60º (LK60º), subjects will be submitted to maximal isometric voluntary contractions (15-18 per session) and to contractions evoked by neuromuscular electrical stimulation (15-18 per session).

LK60º

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Legal adult up to 35
• Males
• Body Massa Index: ≥ 18,5 - 24,9 kg/m²)
• International Physical Activity Questionnaire: active (but not engaged in systematic strengthening training of lower limbs)

You may not qualify if:

• Pain, edema, dermic injury, deformity or amputation in the body parts to be examined;
• Conditions that may affect the studied variables, such as ankylosing spondylitis, rheumatoid arthritis, diabetes mellitus, familial hypercholesterolemia, another neuromuscular disease, congestive heart failure, chronic obstructive pulmonary disease, and chronic alcoholism.
• Conditions that may affect cooperation, such as cognitive or psychiatric disease and chemical dependence.

Sponsors & Collaborators

• University of Brasilia: lead
• University of Burgundy: collaborator

Study Sites (1)

University of Brasília

Brasília, Federal District, 72220-900, Brazil

Location

Related Publications (17)

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• Cavalcante JGT, Marqueti RC, Geremia JM, de Sousa Neto IV, Baroni BM, Silbernagel KG, Bottaro M, Babault N, Durigan JLQ. The Effect of Quadriceps Muscle Length on Maximum Neuromuscular Electrical Stimulation Evoked Contraction, Muscle Architecture, and Tendon-Aponeurosis Stiffness. Front Physiol. 2021 Mar 29;12:633589. doi: 10.3389/fphys.2021.633589. eCollection 2021.

  PMID: 33854439 DERIVED

Study Officials

• João LQ Durigan, PhD

  University of Brasilia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Volunteers will be blinded to the study hypothesis and the reason for positioning changes during the study. One researcher will be blinded for outcomes statistics analysis.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, Assistant Professor

Model Details: After a familiarization session, there will be four sessions for testing the electrical stimulation at four different combinations of hip and knee angles for isometric contractions. The order of the combinations will be randomized, and a washout period of seven days will be reacquired between each session.

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: January 30, 2019
• Study Start: April 15, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

BR (1)