The aim of this study was to compare the effects of core stability exercises and child-centered play therapy on improving static and dynamic balance in deaf female children.
Design
The exercise groups will performe the exercise protocol 3 times a week for 8 weeks. During an introductory session, participants will be introduced to the research process and the implementation of the exercise protocols. Both the CST and CCPT exercise protocols will be performed under the full supervision of a physiotherapist. Each CST and CCPT session will include a warm-up (5 minutes of walking and stretching exercises), the main intervention (i.e., 30 minutes in the first 3 weeks, increasing to 3 sessions per week and up to 45 minutes in the final 5 weeks), and a cool-down (5 minutes). The CST protocol will involve performing 11 different exercises derived from previous studies (20). The CCPT sessions will include a variety of physical challenges and skill-building activities.
Settings and conduct
Before and about 48 hours after the final training session, static and dynamic balance tests will be assessed. The ESS test will be employed to assess static balance and the TUG test will be used to assess dynamic balance
Participants/Inclusion and exclusion criteria
A documented history of absolute or severe deafness, the ability to walk independently, and no physical disabilities
Intervention groups
(i) Core Stability Training (CST), (ii) Child-Centered Play Therapy (CCPT), and (iii) Control group
Main outcome variables
Number of errors in static balance, total time spent performing the dynamic balance test, and overall score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240513061779N3
Registration date:2025-12-30, 1404/10/09
Registration timing:prospective
Last update:2025-12-30, 1404/10/09
Update count:0
Registration date
2025-12-30, 1404/10/09
Registrant information
Name
Nader Hamedchaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3332 2230
Email address
nader.hamedchaman@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-05, 1404/10/15
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effects of core stability training and child-centered play therapy on improving static and dynamic balance in female deaf children
Public title
Comparing the effects of two different balance training protocols on improving balance in deaf female students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Documented history of absolute or severe deafness
Ability to walk independently
No physical disabilities
Exclusion criteria:
Outfit the prerequisitive age range of 10 to 15 years old
Presence or emergence of other physical disabilities
Adding drug treatments that interfere with the hormonal profile or performance of volunteers
Age
From 10 years old to 15 years old
Gender
Female
Phase
4
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with block size = 3 will be divided between the groups; the randomization list will be generated using the "Random allocation" software. So that first, the subjects will be grouped in consecutive blocks of fixed size of 3 in the order of their entry into the study. For each block, a random sequence of group assignments will be generated by specialized "Random allocation" software. This software ensures that the order of the groups within each block is completely random. Then, each new volunteer is assigned to one of the study groups based on their position in the current block and according to a pre-generated list. This method ensures that allocations remain balanced throughout the study and that the probability of allocation bias in short-term time intervals tends to zero.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to prevent the Hawthorne and Avis effect, in the present study, the examiner (clinical caregiver) and the data analyst were unaware of the content and titles of the groupings
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Research Institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2025-12-02, 1404/09/11
Ethics committee reference number
SSRI.REC-2510-3062
Health conditions studied
1
Description of health condition studied
Congenital bilateral deafness
ICD-10 code
H90.0
ICD-10 code description
Conductive hearing loss, bilateral
Primary outcomes
1
Description
Error count in the functional test of standing with one foot on a hard surface
Timepoint
Before and 48 hours subsequent to the 8 weeks of balance training
Method of measurement
Field test of balance on a hard surface
2
Description
Error count in the functional test of standing with one foot on a soft surface
Timepoint
Before and 48 hours subsequent to the 8 weeks of balance training
Method of measurement
Field test of balance on a soft surface
3
Description
Error count in the functional test of tandem standing on a hard surface
Timepoint
Before and 48 hours subsequent to the 8 weeks of balance training
Method of measurement
Field test of balance on a hard surface
4
Description
Error count in the functional test of tandem standing on a soft surface
Timepoint
Before and 48 hours subsequent to the 8 weeks of balance training
Method of measurement
Field test of balance on a soft surface
5
Description
Functional test of Dynamic balance
Timepoint
Before and 48 hours after 8 weeks of balance training
Method of measurement
Field test 3 meters back and forth on a balance beam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8 weeks of performing full-body core stability training based on body weight with a frequency of 3 sessions per week (30 minutes in the first 3 weeks to 45 minutes in the last 5 weeks)
Category
Rehabilitation
2
Description
Intervention group: 8 weeks of game-based exercises (including jogging, chasing, jumping) with a frequency of 3 sessions per week (30 minutes in the first 3 weeks to 45 minutes in the last 5 weeks)
Category
Rehabilitation
3
Description
Control group: daily routine without any special physical activity
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shomal University Gymnastics Hall
Full name of responsible person
Ensiyeh Dashti-Ahangar
Street address
Haraz st
City
Amol
Province
Mazandaran
Postal code
۴۶۱۶۱۸۴۵۹۶
Phone
+98 11 4420 3711
Email
info@shomal.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shomal university
Full name of responsible person
Hossein Ranjbar
Street address
Haraz street
City
Amol
Province
Mazandaran
Postal code
۴۶۱۶۱۸۴۵۹۶
Phone
+98 11 4420 3711
Email
info@shomal.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shomal university
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shomal university
Full name of responsible person
Nader Hamedchaman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Haraz street
City
Amol
Province
Mazandaran
Postal code
۴۶۱۶۱۸۴۵۹۶
Phone
+98 11 4420 3638
Email
nader.hamedchaman@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shomal University
Full name of responsible person
Nader Hamedchaman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Haraz street
City
Amol
Province
Mazandaran
Postal code
۴۶۱۶۱۸۴۵۹۶
Phone
+98 11 4420 3638
Email
nader.hamedchaman@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shomal university
Full name of responsible person
Nader Hamedchaman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Haraz street
City
Amol
Province
Mazandaran
Postal code
۴۶۱۶۱۸۴۵۹۶
Phone
+98 11 4420 3638
Email
nader.hamedchaman@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are no plans to release it
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Some of the volunteers' general characteristics, including their age, medical history, and body composition, will be shared.
When the data will become available and for how long
The access period will begin after the results are printed.
To whom data/document is available
Trainers, clubs and health centers
Under which criteria data/document could be used
Research centers can use non-personally identifiable data to conduct screenings or conduct meta-analysis studies with the aim of examining various aspects of individual health and performance
From where data/document is obtainable
Corresponding author's email address: Dr. Nader Hamedchaman Nader.Hamedchaman@gmail.com
What processes are involved for a request to access data/document
Send an email to the corresponding author - Check the organizational affiliation and purpose of the requester