NCT06353867

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 3, 2024

Last Update Submit

April 3, 2024

Conditions

Keywords

developmental disabilitybalanceattentiongroup exercise

Outcome Measures

Primary Outcomes (5)

  • Bruininks-Oseretsky Motor Competence Test Short Form Balance Subtest (Balance Subtest of BOT 2-KF)

    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

    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

    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

    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

    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)

Study Arms (1)

Group Exercise

EXPERIMENTAL
Other: Group Exercise

Interventions

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.

Group Exercise

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Developmental DisabilitiesAutistic Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersAutism Spectrum DisorderChild Development Disorders, Pervasive

Study Officials

  • Gokce Kartal, PT

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc,PT

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 9, 2024

Study Start

December 27, 2022

Primary Completion

April 15, 2023

Study Completion

April 25, 2023

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations