Assessment by Surface Electromyography in Cerebral Palsy Footballers

May 9, 2024 updated by: Alejandro Caña Pino, University of Extremadura

Adapted sport is constantly evolving thanks to the technological and scientific advances in the field of sports that are being developed in our era. Until a few years ago, the study of training, loads, volumes and work intensities were the focus of attention, but nowadays, expanding towards recovery of the individual and consequently to an improvement of the assessments and treatments from the point of view of the alteration of the movement. Impaired motor control is a consequence of most central nervous system (CNS) movement disorders, such as cerebral palsy. A common physical examination includes assessment of passive muscle elongation endurance, isometric and isotonic testing. This test is used to judge the degree and nature of muscle hyperendurance, to determine etiology at the muscle tissue and/or motor control level, and to infer consequences for overall motor performance in functional tasks. Although this physical examination is in widespread clinical use and provides clinically essential information, it is still a subjective assessment and depends on several factors such as intra- and inter-examiner variability.this variability and subjectivity calls for a consensus on the interpretation and measurement of muscle neurophysiological responses in patients with neurological diseases.Generally, the assessment instruments used for the analysis of hypertonia in adapted sports are based on standardized tests and trials. Specifically, in CP (Cerebral Palsy)-Football, hypertonia is assessed by the degrees of spasticity of the modified Ashworth Scale. There is a need for instrumental assessment to validate subjectivity and thus facilitate the applicability, objectivity, characterization and monitoring of the pathology, such as surface electromyography (EMS).

The tests will be performed in a control group of healthy subjects and an experimental group with subjects belonging to the Spanish National Football Team of cerebral palsy and acquired brain damage. After collecting the records, the behavioral patterns in both groups will be evaluated, establishing possible differences between them for the clinimetric indicators analyzed related to muscle activity, thus allowing a characterization of the sample.

Subsequently, by means of the post-exertion assessment of the experimental group, we will analyze the influence of muscle fatigue after an international soccer match.

Therefore, the development of the project aims to provide clinical health professionals and professionals in sports physical activity with evaluative tools (EMG) sensitive to clinical changes that allow characterizing, classifying and observing the evolution of their athletes through a simple, fast and agile characterization of indicators based on surface electromyography for patients with cerebral palsy and acquired brain damage.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Badajoz, Spain, 06071
        • Universidad de Extremadura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Control group

Inclusion Criteria:

  • healthy subjects with no musculoskeletal, neurological or vestibular disorders

Exclusion Criteria:

  • vestibular, neurological and musculoeskeletal disorders

Experimental group

Inclusion criteria:

- subjects with cerebral palsy/acquired brain damag. FT1, FT2 and FT3 soccer clasification.

Exclusion criteria

- healthy subjects with no musculoskeletal, neurological or vestibular disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy subjects
control group sample, healthy subjects without musculoskeletal, neurological or vestibular disorders may participate.
control group sample, healthy subjects without musculoskeletal, neurological or vestibular alterations can participate.
Subjects with cerebral palsy/acquired brain damage belonging to the Spanish National Soccer Team with cerebral palsy and acquired brain damage may participate as an experimental group.
Experimental: Subjects with neurological damage
Subjects with cerebral palsy/acquired brain damage belonging to the Spanish National Soccer Team with cerebral palsy and acquired brain damage may participate as an experimental group.
control group sample, healthy subjects without musculoskeletal, neurological or vestibular alterations can participate.
Subjects with cerebral palsy/acquired brain damage belonging to the Spanish National Soccer Team with cerebral palsy and acquired brain damage may participate as an experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline muscle activity
Time Frame: one week
Recording of muscle activity by surface electromyography at rest or basal state of the spastic musculature used in the international sports classification: calf-soleus; hamstrings; adductors.The unit is microvolts
one week
Isometric muscle activity
Time Frame: one week
Recording of isometric muscle activity by surface electromyography of the spastic musculature used in international sports classification: calf-soleus; hamstrings; adductors. The unit is microvolts
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: one week
Descriptive variable. Its unit of measurement is Kilograms
one week
Height
Time Frame: one week
Descriptive variable. Its unit of measurement is meters
one week
Age
Time Frame: one week
Descriptive variable. Its unit of measurement is years
one week
sports classification
Time Frame: one week
Descriptive variable. Player classification according to disability. The values are FT1, FT2 and FT3, with FT1 being the most disabled players.
one week
Affected hemibody
Time Frame: one week
Descriptive variable. Affected hemibody. Right, left or both.
one week
Modified Ashworth Scale
Time Frame: one week
The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Actual)

November 17, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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