NCT06151873

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

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

November 17, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

November 20, 2023

Last Update Submit

May 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    one week

  • 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

    one week

Secondary Outcomes (6)

  • weight

    one week

  • Height

    one week

  • Age

    one week

  • sports classification

    one week

  • Affected hemibody

    one week

  • +1 more secondary outcomes

Study Arms (2)

Healthy subjects

ACTIVE COMPARATOR

control group sample, healthy subjects without musculoskeletal, neurological or vestibular disorders may participate.

Diagnostic Test: Adapted sport

Subjects with neurological damage

EXPERIMENTAL

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.

Diagnostic Test: Adapted sport

Interventions

Adapted sportDIAGNOSTIC_TEST

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

Healthy subjects

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects with no musculoskeletal, neurological or vestibular disorders

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Extremadura

Badajoz, 06071, Spain

Location

MeSH Terms

Conditions

Cerebral PalsyTechnology Addiction

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 30, 2023

Study Start

November 17, 2023

Primary Completion

November 17, 2023

Study Completion

December 31, 2023

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations