The Effects of Exercises With Pilates Ball on Balance, Reaction Time and Dual-task Performance of Kindergarten Children

December 1, 2020 updated by: Zehra Güçhan, Eastern Mediterranean University

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

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Famagusta, Cyprus, 99628
        • Zehra Güçhan Topcu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Zehra Güçhan Topcu, Dr., Eastern Mediterranean University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 10, 2020

Study Registration Dates

First Submitted

September 27, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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