- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06198192
Effects of Pilates Exercises on Hearing Impairment Children
June 11, 2024 updated by: Riphah International University
Effects of Pilates Exercises on Static and Dynamic Balance in Children With Hearing Impairment
This study will determine the effects of Pilates exercises on static and dynamic balance in children with hearing impairment.
Children with hearing impairment often encounter challenges in their motor development, including difficulties in maintaining balance and mobility.
Impaired balance and limited mobility can significantly impact their overall physical well-being and functional independence.
Therefore, it becomes crucial to explore effective interventions that can address these specific needs and promote improve balance and mobility in this population.
Pilates, a mind-body exercise approach, has gained recognition for its potential benefits in enhancing balance, flexibility, and core strength in various populations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A Randomized clinical trial will be conducted through convenient sampling.
Subjects will randomly be allocated into two groups experimental group will receive balance exercises in addition to Pilate exercise while control group will receive will receive conventional therapy for strength, balance and postural stability.
The duration of the treatment will be 10 weeks for 3 days a week for 45 minutes.
Pediatric Balance Scale, Pediatric Reach Test (Pediatric Functional Reach Test) and Timed Up and Go Test will be used as outcome measure.
Data will be analyzed on SPSS version 29.0; normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.
Study Type
Interventional
Enrollment (Actual)
38
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
-
-
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
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria.
- Age between 5 to10 years
- Having greater than 24 score of mini mental state examination (MMSE-C) for children
- Children diagnosed with congenital sensorIneural hearing impairment
- Having a hearing loss>75dB
- Able to follow instructions
Exclusion Criteria:
- Presence of any visual, physical or mental disability in addition to hearing loss, or any orthopedic or neurological problem that may affect balance
- Severe hearing losses were greater than75dB
- Parents or patient refuse to take part
- Have participated in other therapy programs during our intervention
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Balance Exercises
This group will receive conventional exercises for balance.
|
this group receive conventional therapy along with balance exercises.
Standing with feet together while the therapist sitting behind and manually locking the child knees, and then slowly tilt him to each side, forward and backward.
Step standing with therapist behind the child guiding him to shift his weight forward then backward alternately.
High step standing and try to keep balanced.
Standing with manual locking of the knees then tries actively to stoop and recover.
Equilibrium, righting and protective reactions training.
Open environment gait training will be conducted with the different obstacles.
Session includes three times/week for total 10 weeks
|
|
Experimental: Pilates Exercises
This group will receive Pilate exercises along with Balance exercises
|
Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions.
Pilate group will receive the intervention program three times/week for total 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Balance Scale
Time Frame: 10 weeks
|
It is 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population in 3 domains sitting, standing and changing of position.
It measures steady state and anticipatory balance activities of varying difficulty that will be performed with or without visual inputs.
Item score from 0-4 which may be measured by the ability to perform the assessed activity.
Item scores will be summed having maximum score of 56 points that indicate perfect score.
Time of administration is 20 minutes.
It has excellent test retest reliability in typically developmental child that is (ICC 0.850)
|
10 weeks
|
|
Pediatric Reach Test (Pediatric Functional Reach Test):
Time Frame: 10 weeks
|
It is used to measure standing balance in pediatric population, it is only done in standing position.
The standing position will be described first and target will be set under the supervision first forward reach will be tested and after this lateral reach will be tested.
Reliability of this test is within rater (0.54, 0.88 ICC) and among the rater is (0.50, 0.93ICC)
|
10 weeks
|
|
Time Up and Go Test (TUG)
Time Frame: 10 weeks
|
It provides valuable measures how quickly one can stand up, walk 10 feet, turn around, walk back and sit down.
Patient sit in the chair on the command go patient rises from the chair walks 3 meters at comfortable and safe pace, turns, walk back to the chair and sits down.
Timings begins with the instruction go and end when the patient is seated.
Reliability of TUG test was high, with ICC of 0.99 for within-session reliability and 0.99 for test-retest reliability analyzes on CP children
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Khushbakhat Butt, 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
- Melo RS, Lemos A, Paiva GS, Ithamar L, Lima MC, Eickmann SH, Ferraz KM, Belian RB. Vestibular rehabilitation exercises programs to improve the postural control, balance and gait of children with sensorineural hearing loss: A systematic review. Int J Pediatr Otorhinolaryngol. 2019 Dec;127:109650. doi: 10.1016/j.ijporl.2019.109650. Epub 2019 Aug 21.
- Rajendran V, Roy FG. An overview of motor skill performance and balance in hearing impaired children. Ital J Pediatr. 2011 Jul 14;37:33. doi: 10.1186/1824-7288-37-33.
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)
December 1, 2023
Primary Completion (Actual)
February 5, 2024
Study Completion (Actual)
February 5, 2024
Study Registration Dates
First Submitted
December 26, 2023
First Submitted That Met QC Criteria
December 26, 2023
First Posted (Actual)
January 10, 2024
Study Record Updates
Last Update Posted (Actual)
June 13, 2024
Last Update Submitted That Met QC Criteria
June 11, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0754
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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