Hearing Disorders in ChildrenNCT03487757
"Core Stabilization Exercises in Hearing Impaired Children"
A study testing Core Stabilization Exercises in people with Hearing Disorders in Children and Core Stabilization, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
In this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Hearing Disorders in Children, Core Stabilization, Respiratory Muscle Strength
- What is being tested?
- Core Stabilization Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Jan 2020
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of 7-16
- Clinically diagnosed sensorineural hearing loss
- Prelingual hearing loss
- No neurological and orthopedic problems
- Absence of syndrome or disease that may lead to mental disorder, impaired development and impaired vision
- Not participating in any core stabilization, strengthening and balance program in the past six months
- No medication to affect respiratory functions in the past 3 months
- Parental permission for participation of child in the study
Who cannot join
- Intellectual disability for participating to the evaluation and training program
- Presence of chronic respiratory disease
- Not to join the training for more than 3 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "The Effect of Core Stabilization Exercises on Respiratory Muscle Strength, Respiratory Functions and Postural Control in Hearing Impaired Children"
In this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.
Read the detailed description
Hearing organs develop together with the vestibular system and work with close cooperation. Because of this close neuro-anatomic relationship; cochlear, semicircular canal, or both may cause damage to the vestibular dysfunction, resulting in imbalance. Sensory impairment in children with hearing loss may lead to decreased muscle strength and respiratory function with balance and coordination disorders. Core stabilization is provided anatomically with abdominal muscles at the front, spinal and gluteal muscles at the back, diaphragm at the top and pelvic floor and hip muscles at the bottom. Core stabilization training is a training to increase the strength, endurance and neuromuscular control of the aforementioned muscles.
When the literature is checked, the invetigators find that postural control is being evaluated in children with hearing impairment, but there are few studies evaluating respiratory functions. However, they did not encounter a study in which respiratory muscle strength was assessed in these children. In this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.
- Conditions
- Hearing Disorders in Children, Core Stabilization, Respiratory Muscle Strength, Respiratory Functions, Postural Control
- Being tested
- Core Stabilization Exercises, No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization ExercisesOther
Jeffrey's core stabilization exercise training protocol will be performed to the training group. This protocol includes exercises progressing gradually from level 1 to level 3. Level 1; static contraction training on a stable surface, level 2; dynamic training on a stable surface, level 3; dynamic and resistant training on an unstable surface.
No InterventionOther
Since no training is given to the control group during the study period, it is ethically necessary to give the same training to the control group if the benefit is achieved when the study is completed.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | After recording the demographic and clinical information at the beginning of the study and after 8 weeks, respiratory muscle strength, respiratory functions and postural control evaluations will be performed to the children. They won't receive any intervention by this time. At the end of 8 weeks, they may be included in the 8-week physiotherapy program, which will be once a week and 45-60 minutes by supervision of physiotherapist and 4 days a week home exercise program. The program will include core stabilization exercise training. Receives: Other: No Intervention |
| Training Group | Experimental | After recording the demographic and clinical information at the beginning of the study, respiratory muscle strength, respiratory functions and postural control evaluations will be performed to the children. They will be included in the 8-week physiotherapy program, which will be once a week and 45-60 minutes by supervision of physiotherapist and 4 days a week home exercise program. The program will include core stabilization exercise training. After the eight week training program the evaluations will be repeated. Receives: Other: Core Stabilization Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
Change from baseline maximum inspiratory pressure and maximum expiratory pressure at 8 weeks
Measured: Eight weeks
Secondary outcomes (7)
Respiratory Functions-FVC
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Measured: Eight weeks
Respiratory Functions-FEV1
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Measured: Eight weeks
Respiratory Functions-PEF
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Measured: Eight weeks
Postural control-postural stability
Change from baseline postural stability test score in Biodex Balance System at 8 weeks
Measured: Eight weeks
Postural control-limits of stability
Change from baseline limits of stability test score in Biodex Balance System at 8 weeks
Measured: Eight weeks
Postural control-sensory integration
Change from baseline sensory integration and balance test core in Biodex Balance System at 8 weeks
Measured: Eight weeks
Postural control-BESS
Change from baseline Balance Error Scoring System (BESS) test scores at 8 weeks
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Jul 2018
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Disorders in ChildrenStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487757
- Sponsor's protocol ID
- bvudtuncer01
- Status last verified
- Mar 2020
- First submitted
- 28 Mar 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tuncer D, Gurses HN. The Effects of Core Stabilization Exercises on Respiratory Muscle Strength, Respiratory Functions, and Postural Control in Children With Hearing Loss: A Randomized Controlled Trial. Ear Hear. 2024 Mar-Apr 01;45(2):306-315. doi: 10.1097/AUD.0000000000001428. Epub 2023 Oct 3.
PubMed 37784232
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Core Stabilization Exercises on Respiratory Muscle Strength, Respiratory Functions and Postural Control in Hearing Impaired Children"
- ClinicalTrials.gov ID
- NCT03487757
- Acronym / sponsor ID
- bvudtuncer01
- Conditions
- Hearing Disorders in Children, Core Stabilization, Respiratory Muscle Strength, Respiratory Functions, Postural Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 4 Apr 2018 (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.
In this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.
Detailed description
Hearing organs develop together with the vestibular system and work with close cooperation. Because of this close neuro-anatomic relationship; cochlear, semicircular canal, or both may cause damage to the vestibular dysfunction, resulting in imbalance. Sensory impairment in children with hearing loss may lead to decreased muscle strength and respiratory function with balance and coordination disorders. Core stabilization is provided anatomically with abdominal muscles at the front, spinal and gluteal muscles at the back, diaphragm at the top and pelvic floor and hip muscles at the bottom. Core stabilization training is a training to increase the strength, endurance and neuromuscular control of the aforementioned muscles.
When the literature is checked, the invetigators find that postural control is being evaluated in children with hearing impairment, but there are few studies evaluating respiratory functions. However, they did not encounter a study in which respiratory muscle strength was assessed in these children. In this study the investigators will examine the effects of core stabilization exercises on respiratory muscle strength, respiratory functions and postural control in hearing-impaired children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: No InterventionAfter recording the demographic and clinical information at the beginning of the study and after 8 weeks, respiratory muscle strength, respiratory functions and postural control evaluations will be performed to the children. They won't receive any intervention by this time. At the end of 8 weeks, they may be included in the 8-week physiotherapy program, which will be once a week and 45-60 minutes by supervision of physiotherapist and 4 days a week home exercise program. The program will include core stabilization exercise training. |
| Training Group | Experimental | Other: Core Stabilization ExercisesAfter recording the demographic and clinical information at the beginning of the study, respiratory muscle strength, respiratory functions and postural control evaluations will be performed to the children. They will be included in the 8-week physiotherapy program, which will be once a week and 45-60 minutes by supervision of physiotherapist and 4 days a week home exercise program. The program will include core stabilization exercise training. After the eight week training program the evaluations will be repeated. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Between the ages of 7-16
- Clinically diagnosed sensorineural hearing loss
- Prelingual hearing loss
- No neurological and orthopedic problems
- Absence of syndrome or disease that may lead to mental disorder, impaired development and impaired vision
Key exclusion criteria (3 listed)
- Intellectual disability for participating to the evaluation and training program
- Presence of chronic respiratory disease
- Not to join the training for more than 3 days
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 |
|---|---|---|
| Core Stabilization ExercisesJeffrey's core stabilization exercise training protocol will be performed to the training group. This protocol includes exercises progressing gradually from level 1 to level 3. Level 1; static contraction training on a stable surface, level 2; dynamic training on a stable surface, level 3; dynamic and resistant training on an unstable surface. | Other | Training Group |
| No InterventionSince no training is given to the control group during the study period, it is ethically necessary to give the same training to the control group if the benefit is achieved when the study is completed. | Other | Control Group |
Primary outcome
Respiratory muscle strength
Time frame: Eight weeks
Change from baseline maximum inspiratory pressure and maximum expiratory pressure at 8 weeks
7 secondary outcomes
Respiratory Functions-FVC
Time frame: Eight weeks
Respiratory Functions-FEV1
Time frame: Eight weeks
Respiratory Functions-PEF
Time frame: Eight weeks
Postural control-postural stability
Time frame: Eight weeks
Postural control-limits of stability
Time frame: Eight weeks
Postural control-sensory integration
Time frame: Eight weeks
Postural control-BESS
Time frame: Eight weeks
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 11 Mar 2020.
- Derived from this study: PubMed 37784232Tuncer D, Gurses HN. The Effects of Core Stabilization Exercises on Respiratory Muscle Strength, Respiratory Functions, and Postural Control in Children With Hearing Loss: A Randomized Controlled Trial. Ear Hear. 2024 Mar-Apr 01;45(2):306-315. doi: 10.1097/AUD.0000000000001428. Epub 2023 Oct 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization Exercises in people with Hearing Disorders in Children and Core Stabilization, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 8 inclusion and 3 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 11 Mar 2020. 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 Turkey (Türkiye). 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?
Respiratory muscle strength (time frame: Eight weeks). 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 NCT03487757, which also lists 1 linked publication.
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 11 Mar 2020.