Hearing Impaired ChildrenNCT06198192
Effects of Pilates Exercises on Hearing Impairment Children
A study testing Pilates Exercises and Conventional Therapy and Balance Exercises in people with Hearing Impaired Children, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Pilates Exercises and Conventional Therapy and Balance Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Impaired Children
- Being tested
- Pilates Exercises, Conventional Therapy and Balance Exercises
- Keywords
- Balance, Hearing Impairment, Pilate exercises
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExercisesOther
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
Conventional Therapy and Balance ExercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Balance Exercises | Active comparator | This group will receive conventional exercises for balance. Receives: Other: Conventional Therapy and Balance Exercises |
| Pilates Exercises | Experimental | This group will receive Pilate exercises along with Balance exercises Receives: Other: Pilates Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale
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)
Measured: 10 weeks
Pediatric Reach Test (Pediatric Functional Reach Test):
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)
Measured: 10 weeks
Time Up and Go Test (TUG)
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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khushbakhat Butt, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198192
- Sponsor's protocol ID
- REC/RCR&AHS/23/0754
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21756300Melo 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.
PubMed 31466025
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pilates Exercises on Static and Dynamic Balance in Children With Hearing Impairment
- ClinicalTrials.gov ID
- NCT06198192
- Acronym / sponsor ID
- REC/RCR&AHS/23/0754
- Conditions
- Hearing Impaired Children
- Keywords
- Balance, Hearing Impairment, Pilate exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Exercises | Active comparator | Other: Conventional Therapy and Balance ExercisesThis group will receive conventional exercises for balance. |
| Pilates Exercises | Experimental | Other: Pilates ExercisesThis group will receive Pilate exercises along with Balance exercises |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates ExercisesTen 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 | Other | Pilates Exercises |
| Conventional Therapy and Balance Exercisesthis 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 | Other | Balance Exercises |
Primary outcome
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)
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 21756300Rajendran 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.
- Background: PubMed 31466025Melo 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.
- Individual participant dataSharing planned: No
Related trials for Hearing Impaired Children
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Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khushbakhat Butt, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercises and Conventional Therapy and Balance Exercises in people with Hearing Impaired Children, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Balance Scale (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198192, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.