NCT06573918

Brief Summary

Paratonia is the inability to relax muscles during the assessment of muscle tone in the absence of spasticity and parkinsonian rigidity. It can be evaluated qualitatively using clinical scales and objectively through surface electromyography (EMG-assessed paratonia). It is widely accepted that paratonia represents a manifestation of impaired motor response inhibition due to frontal lobe dysfunction. Traditionally, motor response inhibition has been assessed using experimental protocols such as go/no-go and stop-signal tasks. Research has shown that athletes, particularly those engaged in open-skill sports, demonstrate superior motor response inhibition compared to sedentary individuals. Even amateur athletes exhibit better motor response inhibition than sedentary individuals, though to a lesser extent than professional athletes. Given that the etiology of paratonia involves a defect in motor response inhibition, it is hypothesized that EMG-assessed paratonia could become a novel approach for evaluating motor response inhibition. The present study was designed to validate this hypothesis. Specifically, we first tested whether EMG-assessed paratonia in healthy subjects can reveal a well-known aspect of motor response inhibition, namely its correlation with the level of physical activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 23, 2024

Last Update Submit

August 23, 2024

Conditions

Keywords

Electromyography Physical activityMotor inhibitionFrontal circuitsSport-specific

Outcome Measures

Primary Outcomes (2)

  • Neuromuscular excitation of the Biceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension

    Amplitude of electromyography value (Root Mean Square in microvolt) measured for Biceps Brachii muscle

    Throughout the duration of the evaluation, which lasts about 120 seconds

  • Neuromuscular excitation of the Triceps Brachii (paratonia assessed by EMG) during passive elbow flexion and extension

    Amplitude of electromyography value (Root Mean Square in microvolt) measured for Triceps Brachii muscle

    Throughout the duration of the evaluation, which lasts about 120 seconds

Study Arms (1)

EMG-assessed paratonia group

EXPERIMENTAL

The study evaluated EMG-assessed paratonia to measure motor response efficiency across three groups of healthy young adults with varying physical activity levels: professional athletes (in both open and closed skills sports), amateurs, and sedentary individuals. Surface electrodes were placed on the biceps and triceps brachii muscles during passive elbow movements while participants remained relaxed. EMG activity detected during these movements was used to quantify the level of paratonia, indicating the participants' ability to relax their muscles.

Diagnostic Test: EMG-based assessment of paratonia

Interventions

EMG-assessed paratonia was analyzed and compared to assess motor response efficiency in three groups of healthy young adults with different levels of physical activity: professional athletes engaged in closed and open skills sports, amateurs, and sedentary individuals. To analyze EMG-assessed paratonia, two surface electrodes were attached to the biceps and triceps brachii muscles during passive flexion-extension movements of the elbow while the participant remained in a state of maximum relaxation. Any EMG activity detected during these movements was attributed to an inability to relax, thereby reflecting their degree of paratonia.

EMG-assessed paratonia group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary Individuals: Defined as those engaging in less than 16.67 metabolic equivalent of task (MET) hours per week.
  • Amateur Athletes: Defined as individuals who engage in 16.67 to 25 MET hours per week.
  • Professional Athletes: Defined as individuals who engage in more than 25 MET hours per week.

You may not qualify if:

  • Presence of any pathology or pain in the flexor or extensor muscles of the arm. Use of muscle stimulants, relaxants, steroids, tobacco, alcohol, or any other drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi di Genova

Genova, 16122, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigatior

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 27, 2024

Study Start

April 18, 2024

Primary Completion

July 18, 2024

Study Completion

July 23, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations