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Assessment, SelfNCT06151873

Assessment by Surface Electromyography in Cerebral Palsy Footballers

A study testing Adapted sport in people with Assessment, Self and Cerebral Palsy, run by University of Extremadura at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age, men onlyHealthy volunteers can take part
What is being tested?
Adapted sport
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
17 Nov 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • healthy subjects with no musculoskeletal, neurological or vestibular disorders
  • subjects with cerebral palsy/acquired brain damag. FT1, FT2 and FT3 soccer clasification.

Who cannot join

  • vestibular, neurological and musculoeskeletal disorders
  • Experimental group
  • healthy subjects with no musculoskeletal, neurological or vestibular disorders

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universidad de Extremadura

    Badajoz, 06071

Other trials in Spain

About this study

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.

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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.

Being tested
Adapted sport
Medical subject headings
Cerebral Palsy, Technology Addiction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted sportDiagnostic test

    control group sample, healthy subjects without musculoskeletal, neurological or vestibular alterations can participate.

  • Adapted sportDiagnostic test

    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.

Study groups in NCT06151873
Study groupRoleWhat they receive
Healthy subjectsActive comparatorcontrol group sample, healthy subjects without musculoskeletal, neurological or vestibular disorders may participate.
Receives: Diagnostic Test: Adapted sport
Subjects with neurological damageExperimentalSubjects 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.
Receives: Diagnostic Test: Adapted sport

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline muscle activity

    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

    Measured: one week

  2. Isometric muscle activity

    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

    Measured: one week

Secondary outcomes (6)
  1. weight

    Descriptive variable. Its unit of measurement is Kilograms

    Measured: one week

  2. Height

    Descriptive variable. Its unit of measurement is meters

    Measured: one week

  3. Age

    Descriptive variable. Its unit of measurement is years

    Measured: one week

  4. sports classification

    Descriptive variable. Player classification according to disability. The values are FT1, FT2 and FT3, with FT1 being the most disabled players.

    Measured: one week

  5. Affected hemibody

    Descriptive variable. Affected hemibody. Right, left or both.

    Measured: one week

  6. Modified Ashworth Scale

    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.

    Measured: one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2023
  2. Study start17 Nov 2023
  3. Primary completion17 Nov 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06151873
Sponsor's protocol ID
171123
Status last verified
May 2024
First submitted
20 Nov 2023
Last updated
10 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Adapted sport in people with Assessment, Self and Cerebral Palsy, run by University of Extremadura at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline muscle activity (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.

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