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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04575441
Other study ID # 2019/0211
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date October 10, 2020

Study information

Verified date December 2020
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects of exercises conducted with pilates ball on balance, reaction time, quality of life, and behavior among preschool children. 60 volunteers, aged 4 and 5 years old, who continue kindergartens will randomly be grouped into two as study group (SG) (n=30) and control group (CG) (n=30). Exercises including pilates ball will be applied to SG children for 40 minutes, twice a week, 6 weeks. CG will continue normal daily routines for 6 weeks. Sociodemographic information of all people will be recorded after their parents signed informed consent form. Single Leg Standing (eyes open and close) for static balance, Functional Reach Test (FRT)for dynamic balance, Ruler Drop Test for reaction time, dual task performance methods will be used.


Description:

Exercises are generally suggested starting from primary school children. However, exercise habit should be given to people from earlier ages. Moreover, doing exercise can be beneficial to improve motor skills of this age and this improvement can support other developmental areas of these children. Thus, this study aims to investigate the effects of an exercise routine on balance, reaction time and dual task performance of preschool children. This exercise program includes pilates ball to make more fun for this age group. All movements are conducted with the same pilates ball. Exercises are conducted with individual sessions in the kindergartens of children.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date October 10, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 5 Years
Eligibility Inclusion Criteria: - having a birth year 2015 or 2016. Exclusion Criteria: - Having cognitive, physical and/or orthopedic problem - Any pain which may prevent doing exercise - Having visual and/or auditory loss

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise with pilates ball
Pilates ball exercises are used to give various sensory stimulation and increase motor skills. Children usually enjoy these kind of exercises as there is ball in every movement.

Locations

Country Name City State
Cyprus Zehra Güçhan Topcu Famagusta

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dynamic balance Functional reach test is used. Children are asked to stand next to the wall with their right side and extend their right arm with 90 degree shoulder flexion. Then they are asked to extend with their arm as far as possible by protecting their lower limb posture. The distance is recorded in cm. change from baseline at 6 weeks
Secondary Static balance Children are asked to stand on dominant leg. Their standing duration is recorded. change from baseline at 6 weeks
Secondary Reaction time Ruler drop test is used to measure reaction time. A rule of 50 cm long is used. Children are asked to catch the ruler as fast as possible. Since the ruler is left with its zero point below, distance is recorded in cm as the result of this outcome. change from baseline at 6 weeks
Secondary Dual task performance Timed-up and go (TUG) test is used as a motor skill and a cognitive task is asked from children as a second task. For timed up and go test, a three meter pathway will be marked with red colored masking tape. The TUG test is administered using 2 standard chairs and children are asked to walk in a self preferred speed. At the same time, children are asked to count many animal names. change from baseline at 6 weeks
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