The Effect of Group Exercise in Children With Special Needs

April 3, 2024 updated by: Gokce Kartal, Istanbul Gedik University

The Effect of Group Exercise on Balance and Attention Level in Children With Special Needs

Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention.

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.

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.
30

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 Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara 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

No

Description

Inclusion Criteria:

  • Children aged 6-15 years with special needs
  • Able to walk independently

Exclusion Criteria:

  • Children with visual problems,
  • Any orthopaedic, rheumatic or neurological problems affecting balance,
  • Any contraindication to exercise

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group 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: Group Exercise
Other: Group Exercise
The children with special needs included in the study were included in group exercises for 45 minutes 2 days a week in groups of 10 children each. Group exercises were planned as balance and coordination exercises including warm-up and cool-down periods. In the warm-up and cool-down periods, counting in place and balance exercises were performed. The exercises included tasks such as side walking, tandem walking, walking on a balance board, walking in a figure 8, walking over obstacles, throwing a ball to the person next to him/her while passing through cones, and throwing a ball by jumping while passing through cones.The exercises were made more difficult by following a progressive method every 2 weeks. The exercises were performed in 3 sets of 5 repetitions under the supervision of a physiotherapist.

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
Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF)
Time Frame: Baseline and after the interventions (4th week)
  1. Standing on the dominant leg on the balance board: The participant will be asked to stand on the balance board with his/her eyes open on his/her dominant foot, looking at the target, with his/her hands on his/her waist and the other leg parallel to the ground for 10 seconds. Scoring will be recorded as 0-0.9 s 0 points, 1-2.9 s 1 point, 3-5.9 s 2 points, 6-9.9 s 3 points and 10 s 4 points according to the duration of standing on one leg.
  2. Tandem (heel-thumb) walking on the walking line: The participant will be asked to place his/her hands on his/her waist and walk along the walking line. When 6 steps are completed, the test is stopped. Steps that does not go beyond the line are evaluated. Scoring is done as 0 step 0 points, 1-2 steps 1 point, 3-4 steps 2 points, 5 steps 3 points and 6 steps 4 points.
Baseline and after the interventions (4th week)
Paediatric Balance Scale
Time Frame: Baseline and after the interventions (4th week)
The version consisting of 14 sections and each section scored between 0-4 is used to evaluate the balance status of the participants.
Baseline and after the interventions (4th week)
Functional Reach Test
Time Frame: Baseline and after the interventions (4th week)
The participant is asked to reach as far as he/she can horizontally at the level of a tape measure fixed to the wall with arms at 90 flexion. The test is repeated 3 times and the measurements are averaged.
Baseline and after the interventions (4th week)
Timed Up and Go Test
Time Frame: Baseline and after the interventions (4th week)
It will be applied to assess balance and functional ambulation. The participant is asked to get up from a chair, walk 3 metres, turn around and sit down again. The time it took to complete the test will be recorded.
Baseline and after the interventions (4th week)
Stroop Test
Time Frame: Baseline and after the interventions (4th week)
The Stroop Test is among the neuropsychological tests frequently used to assess attention level and executive functions in children. Participants' time to complete the test is recorded.
Baseline and after the interventions (4th week)

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.
Istanbul Gedik 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: Gokce Kartal, PT, Marmara University

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 27, 2022

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.
April 15, 2023

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.
April 25, 2023

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).
April 3, 2024

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.
April 3, 2024

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.
April 9, 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.
April 9, 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.
April 3, 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.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 56365223-050.01.04-2023.13754

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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