- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04575441
The Effects of Exercises With Pilates Ball on Balance, Reaction Time and Dual-task Performance of Kindergarten Children
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Famagusta, Cyprus, 99628
- Zehra Güçhan Topcu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates Ball Exercises
Various exercises are conducted with using pilates ball.
Sensory feedbacks like proprioception and vestibulation are given.
Many physical fitness parameters like balance, coordination, speed and agility are used in this exercise program.
Children are taken to the program for 40 min, twice a week during 6 weeks.
|
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.
|
|
No Intervention: Without exercise
The children in this group are not included in any kind of exercise/sport program during 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic balance
Time Frame: change from baseline at 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static balance
Time Frame: change from baseline at 6 weeks
|
Children are asked to stand on dominant leg.
Their standing duration is recorded.
|
change from baseline at 6 weeks
|
|
Reaction time
Time Frame: change from baseline at 6 weeks
|
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
|
|
Dual task performance
Time Frame: change from baseline at 6 weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zehra Güçhan Topcu, Dr., Eastern Mediterranean University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019/0211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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