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

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.

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."

Study Overview

• Status: Unknown
• Conditions: Physical Activity; Social Skills; Down Syndrome
• Intervention / Treatment: Other: Survey

Detailed Description

This study is a non-randomized survey. The aim of the current protocol is to describe how will be the process to get information about the participant, the questionnaire design and how was validated and the planned analysis of results.

Participants: Around 150 Down Syndrome people from Cordoba, Malaga y Granada who belong to The Down Syndrome association and 150 parents, family, tutors, teachers etc.

Consent process: Before designing the survey, consent was requested from the management team Down of Córdoba, Malaga and Gradana associations, as well as family members, parents, tutors, teachers, etc.

Standard Operating Procedures: First, RC (author) gathered as much information as possible about the subject under study and selected the most important topics related to the research focus. After that, the questionnaire was designed modifying the KidsLife-Down Scale. The questionnaire will be divided into three parts.

An introduction to the questionnaire describes the instructions, structure, the reasons for the study and confidentiality in accordance with the Spanish Organic Law 3/2018 on the Protection.

The first part of the questionnaire will assess self-perception from people with Down about their social skills. The second will evaluate the opinion of this issue from other people who know them well (at least for six months) and who have the opportunity to observe the person evaluated for extended periods of time (parents, family, tutors, teachers etc.). Finally, for the third part, it will be used the International Physical Activity Questionnaire (IPAQ) for the purpose of collecting information about the types of physical activity do in their daily routines. The questions will be referred to the time they have been physically active in the last 7 days.

Second, the questionnaire was sent to the Down Syndrome Association of Córdoba (DSAC) so that they reviewed the possible mistakes made when defining the questions and validate it. After that, Down Malaga and Down Granada Association found the questionnaire understandable and acceptable.

Third, they gave the corresponding feedback that served to formulate the questions in the appropriate way to avoid confusion in the surveyed.

The questionnaire will be sent by e-mail to the Cordoba Association and a paper version will available for participants. From Córdoba, it will be spread to Málaga and Granada Associations in order it will be distributed among associates.

Analysis of results: Estimated outcomes will be percentages of agreement with each answer. Data from all surveys will be analyzed. The statistical study will be carried out with the SPSS 24.0 program. The mean value and standard deviation (± SD) of each item will be calculated on a numerical scale. Statistical analysis will be performed with parametric tests, t-Student for related samples. The level of statistical significance will be calculated.

Two of the authors (RC and JC) will analyse de data, and results will be discussed among the work team.

Conducting a pilot test or pre-test before applying the survey will help to detect possible failures and optimize the results of our survey. Despite its importance, should not consider the pilot study as a substitute for a careful wording of the questionnaire.

Report on the survey: Before writing the report, It will be reviewed the data for errors and inconsistencies. Make sure the data reflects exactly what the survey concludes. The conclusion will summarize the results.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Estrella Agüera, Doctor; Phone Number: +34669808974; Email: ba1agbue@uco.es

Study Locations

• Spain
  • Córdoba, Spain, 14071
    • Estrella Agüera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders 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.).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Others metal incapacities
• Others Asociation

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Other

Number of groups / cohorts

6

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Types of physical activities carried out by Down Syndrome people	To know which types of physical activities are carried out by Down Syndrome people using a survey	6 months

Collaborators and Investigators

• Sponsor: Universidad de Córdoba
• Investigators: Study Director: Estrella Agüera, Dotor, Universidad de Córdoba

Study record dates

Study Major Dates

• Study Start (Anticipated): September 26, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; Well-being; self-determination; Social inclusion; Rights; Interpersonal relations
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: University of Cordoba, Spain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing Access Criteria: Data access request will be reviewed by an external Independent Review Panel. Requestors will be required to sing a Data Access Agreement.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No