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Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.

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ClinicalTrials.gov Identifier: NCT04037579
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Estrella Agüera Buendía, Universidad de Córdoba

Brief Summary:
This survey arises from one objective of a PhD thesis whose purpose is to "Identify what social skills people with Down syndrome have that do a routine activity and compare them with those developed by those SD people who perform sports activities."

Condition or disease Intervention/treatment
Down Syndrome Social Skills Physical Activity Other: Survey

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Official Title: Protocol for a Non-randomized Survey to Evaluate Social Skills and Physical Capacity Improvement in Down Syndrome People Who Routinely Practice Sports. Self and Observers´ Perception.
Estimated Study Start Date : September 26, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Group/Cohort Intervention/treatment
Down Syndrome Cordoba Association
The participant will answer a questionnaire related to social skills and physical activity
Other: Survey
Non-randomised survey

Down Syndrome Granada Association
The participant will answer a questionnaire related to social skills and physical activity
Other: Survey
Non-randomised survey

Down Syndrome Malaga Association
The participant will answer a questionnaire related to social skills and physical activity
Other: Survey
Non-randomised survey

Observers in Cordoba
Observers from Cordoba, Spain who know Down Syndrome people well (at least for six months) will answer a questionnaire related to their social skills and physical activity
Other: Survey
Non-randomised survey

Observers in Granada
Observers from Granada, Spain who know Down Syndrome people well (at least for six months) will answer a questionnaire related to their social skills and physical activity
Other: Survey
Non-randomised survey

Observers in Malaga
Observers from Malaga, Spain who know Down Syndrome people well (at least for six months) will answer a questionnaire related to their social skills and physical activity
Other: Survey
Non-randomised survey




Primary Outcome Measures :
  1. Sport effect on social skills in Down Syndrome people [ Time Frame: 6 months ]
    To Evaluate sport effect on social skills in Down Syndrome people using a survey


Secondary Outcome Measures :
  1. Types of physical activities carried out by Down Syndrome people [ Time Frame: 6 months ]
    To know which types of physical activities are carried out by Down Syndrome people using a survey



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Down Syndrome people who practise sports and a people who know them well (at least for six months) and who have the opportunity to observe person evaluated for extended periods of time (parents, family, tutors, teachers etc.).
Criteria

Inclusion Criteria:

  • Down syndrome
  • Do sport
  • Belonging to Cordoba, Mágala and Granada Associatio

Exclusion Criteria:

  • Others metal incapacities
  • Others Asociation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037579


Contacts
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Contact: Estrella Agüera, Doctor +34669808974 ba1agbue@uco.es

Locations
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Spain
Estrella Agüera Active, not recruiting
Córdoba, Spain, 14071
Sponsors and Collaborators
Universidad de Córdoba
Investigators
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Study Director: Estrella Agüera, Dotor Universidad de Córdoba

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Responsible Party: Estrella Agüera Buendía, Professor. Responsible of AGR-019 Research Group, Universidad de Córdoba
ClinicalTrials.gov Identifier: NCT04037579     History of Changes
Other Study ID Numbers: University of Cordoba, Spain
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data access request will be reviewed by an external Independent Review Panel. Requestors will be required to sing a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Estrella Agüera Buendía, Universidad de Córdoba:
physical activity
self-determination
Social inclusion
Well-being
Rights
Interpersonal relations

Additional relevant MeSH terms:
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Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn