Effects of Pilates Exercises on Balance and Gait in School Children

June 11, 2024 updated by: Riphah International University

Effects of Pilates Exercises on Balance and Gait in School Going Children

The school children often spend prolonged hours in sedentary activities and may not engage in sufficient physical exercise A sedentary lifestyle among school-going children is a growing concern in modern society. Children are spending more time sitting down and less time being physically active. This can lead to a variety of health problems, including obesity, poor posture, and a lack of cardiovascular fitness. Postural control is crucial for children's balance, gait, and functional tasks, and core stability and hip muscle strength play significant roles in maintaining proper posture and facilitating movement. Pilates is a popular exercise program known for improving core strength, balance, flexibility, and posture. Understanding the potential benefits of Pilates exercises on muscle strength and postural control in this population is essential, considering the sedentary lifestyles of many school children. Limited research has examined the effectiveness of Pilates exercises in school-aged children This randomized controlled trial will be conducted in schools in Daska City Govt. girls high school Raj okay Tehsil DASKA, Govt Girls elementary school KOT JANDHU Tehsil DASK e.g over a duration of six months. The sample size will consist of 96 children aged 6 to 9 years, divided equally into a control group and an experimental group. The inclusion criteria specify children without acute illnesses or injuries, within the normal BMI range, and free from cognitive impairments or chronic medication use. The control group will receive exercises that will focus on flexibility, strength, and endurance targeting postural stability for 45 minutes, while the experimental group will receive program of exercises including 15 minutes of conventional exercise along(strengthening, flexibility exercises) with 30 minutes of Pilates excercises including ( back twists, single leg circles, standing splits, alternate toe touches, ball leg lifts) for 3 times a week, of Pilates exercises aimed at improving lower-limb strength, flexibility, and coordination. Assessments will be conducted at baseline, 4th week, and 8th-week using measures such as the Pediatric Berg Balance Scale, walking speed assessment, FRT.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The sample size will consist of 96 children aged 6 to 9 years, divided equally into a control group and an experimental group. The inclusion criteria specify children without acute illnesses or injuries, within the normal BMI range, and free from cognitive impairments or chronic medication use. The control group will receive exercises that will focus on flexibility, strength, and endurance targeting postural stability for 45 minutes, while the experimental group will receive program of exercises including 15 minutes of conventional exercise (strengthening, flexibility exercises) along with 30 minutes of Pilates exercises including ( back twists, single leg circles, standing splits, alternate toe touches, ball leg lifts) for 3 times a week. Each session will be started with a 5-minute warm-up and concluded with a 5-minute cool-down. Pilates exercises aimed at improving lower-limb strength, flexibility, and coordination. Assessments will be conducted at baseline, 4th week, and 8th-week using measures such as the Paediatric Berg Balance Scale, walking speed assessment, FRT. This randomized controlled trial will be conducted in schools in Daska City Govt. girls high school Raj okay Tehsil DASKA, Govt Girls elementary school KOT JANDHU Tehsil DASK e.g over a duration of six months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Riphah International University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children between the ages of 6 and 9 years
  • Both male and female students.
  • Students with normal BMI.
  • Students willingness for participation.

Exclusion Criteria:

  • Students with cognitive impairments.
  • Students with conditions such as chronic fatigue, myalgia, limb deformity or any orthopedic condition.
  • Students who are currently taking any form of medication for chronic illnesses.
  • Students with limb deformities e.g flat foot, genuvelgum, genuvarum and leg length discrepancy.
  • Students with any type of psychological problem.
  • Children who have participated in similar Pilates or physical therapy exercise programs targeting balance and gait in the past six months

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates exercises
The experimental group will receive the same program of exercises given to the control group, 45 minutes of Pilates exercises (such as back twists, single leg circles, standing splits, alternate toe touches, ball leg lifts).The Pilates exercises will be aimed at improving lower-limb strength, flexibility, and coordination, and they will be performed on a mat, using a medical ball. The focus will be on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed, with a 2-minute rest period between repetitions.
Other: Pilates exercises
Pilates exercises
Active Comparator: Flexibility ,strength and endurance excercises
Control group will perform flexibility exercises for the hip (flexors and adductors), knee (flexors and extensors), and calf muscle, with a hold of 15 sec ,5 repetitions. Strengthening exercises for core muscles (curl-ups, prone extension),hip extensors (in prone position), hamstrings, quadriceps (knee extension in high sitting).Walking in all directions, standing on rough and soft surfaces, stepping down and up, walking,standing on one limb with both eyes closed and open. Each session will start with a 5-minute warm-up and 5-minute cool-down, session duration 45 minutes,3 times a week.
Other: Flexibility ,strength and endurance excercises
flexibility ,strength and endurance excercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pediatric berg balance scale
Time Frame: 8 weeks
The Pediatric Balance Scale (PBS) is an assessment tool consists of 14 different balance tasks that challenge various aspects of balance control, including static and dynamic balance (6) The tasks involve different postural positions, such as sitting, standing, and transferring weight, and may require the child to maintain balance while performing specific movements or tasks. Intra class correlation coefficient (ICC) = 0.998] or individual items (Kappa Coefficients, k = 0.87 to 1.0)
8 weeks
walking speed assessment
Time Frame: 8 weeks
The walking speed assessment will utilize a 6-minute walk test in which the child will be instructed to walk back and forth in a designated hallway for 6 minutes. They will pivot briskly around cones without hesitations. Participants will be accompanied by the assessor, who will be positioned just behind them without leading or influencing their walking speed. The assessment will be conducted before and after the exercise intervention to assess improvements in basic mobility. Strong test-retest reliability was demonstrated (intra class correlation = 0.97).
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
functional reach test
Time Frame: 8 weeks
The test involves the participant standing next to a wall, with their arm at 90 degrees of shoulder flexion and a closed fist. The starting position is recorded, and the participant is instructed to reach forward as far as possible without taking a step. The distance between the starting and ending positions is measured and recorded. Three trials will be performed, and the average of the last two trials will be noted. The reach distance is typically measured in inches. The criteria for stopping the test include the patient's feet lifting off the floor or falling forward. The intra-class correlation coefficient range 0.90 - 0.97).
8 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: kirn arshad, MS*, Riphah International 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/23/0758

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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