Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
1 other identifier
observational
300
1 country
1
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."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
July 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedStudy Start
First participant enrolled
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 31, 2019
July 1, 2019
2 months
July 26, 2019
July 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sport effect on social skills in Down Syndrome people
To Evaluate sport effect on social skills in Down Syndrome people using a survey
6 months
Secondary Outcomes (1)
Types of physical activities carried out by Down Syndrome people
6 months
Study Arms (6)
Down Syndrome Cordoba Association
The participant will answer a questionnaire related to social skills and physical activity
Down Syndrome Granada Association
The participant will answer a questionnaire related to social skills and physical activity
Down Syndrome Malaga Association
The participant will answer a questionnaire related to social skills and physical activity
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
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
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
Interventions
Non-randomised survey
Eligibility Criteria
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.).
You may qualify if:
- Down syndrome
- Do sport
- Belonging to Cordoba, Mágala and Granada Associatio
You may not qualify if:
- Others metal incapacities
- Others Asociation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Estrella Agüera
Córdoba, 14071, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Estrella Agüera, Dotor
Universidad de Córdoba
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor. Responsible of AGR-019 Research Group
Study Record Dates
First Submitted
July 26, 2019
First Posted
July 30, 2019
Study Start
September 26, 2019
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
July 31, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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.
De-identified individual participant data for all primary and secondary outcome measures will be made available