BalanceBalanceNCT05404126
Balance and Gait in Hearing Impaired Children
A study testing exercise in people with Balance and Gait, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
The investigators balance and balance related problems and exercise programs should be handled multi-dimensionally. In this study, the investigators' aim is to investigate the effect of dual task-oriented education with stroboscopic glasses on balance, functional mobility and general walking parameters in children… Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Jan 2023
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In Hearing Impaired Groups
- Between the ages of 7-12,
- Not undergoing cochlear implant surgery,
- Able to walk independently,
- Having a hearing threshold of 71 decibels (dB) and above according to the hearing test,
- Volunteers diagnosed with congenital bilateral sensorineural hearing impairment,
Show all 9Show fewer
- In the Healthy Group
- Between the ages of 7-12,
- Able to walk independently
Who cannot join
- In Hearing Impaired Groups
- In addition, having any physical or visual disability,
- Lack of cooperation for the application,
- Volunteers with a neurological or any orthopedic problem other than sensorinoral hearing loss that may affect their balance.
- In the Healthy Group
- Having any physical, visual or hearing impairment,
- Lack of cooperation for the application.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nvestigation of the Effect of Dual-Task Focused Stroboscopic Visual Education on Balance and Gait in Hearing Impaired Children
The investigators balance and balance related problems and exercise programs should be handled multi-dimensionally. In this study, the investigators' aim is to investigate the effect of dual task-oriented education with stroboscopic glasses on balance, functional mobility and general walking parameters in children with hearing impairment, despite conventional balance exercises.
The study will be started when the consent form which prepared in accordance with the ethical committee conditions, explained and approved to all participants and their families. Participants aged 7-12 years, who have not undergone cochlear implant surgery, who can walk independently, have a hearing threshold of 75 decibels (dB) and above, and are diagnosed with congenital bilateral sensorineural hearing impairment will be included in the study. Hearing impaired children who have physical, visual impairment, lack of cooperation for the application and have any neurological problems (other than sensorineural hearing loss) or orthopedic problems that may affect their balance will not be included. Children who meet the inclusion criteria will be divided into three groups by block randomization method; as control (Group 1), conventional exercise balance (Group 2), dual task-oriented stroboscopic visual training group (Group 3) and a healthy control group (Group 4) without any disability will form the fourth group. Only assessments and scales will be applied to the participants in Group 1 and Group 4 at the beginning of the study and at the end of 12 weeks. Group 2 and Group 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Conventional balance exercises are planned to be done in groups, and other trainings are planned with one-on-one therapist. Before starting exercise training, demographic characteristics such as dB values (specified in the health reports of), age (years), height (cm), body weight (kg) of the children included in the study will be recorded. At the beginning of the exercise training and at the end of the 12-week training; balance, functional mobility and gait, fall history and fear of falling, quality of life, hand-eye coordination will be evaluated.
This study is important in terms of being an example for researches to be carried out for the hearing impaired or other disability groups and contributing to the exercise programs of the trainers working in this field.
Read the detailed description
One of the important problem in individuals with congenital hearing impairment is the functional insufficiency of the balance centers that work in conjunction with each other because they cannot perceive auditorily external stimuli. Although the visual perceptions, proprioceptors and antigravity muscles work well,if vestibular system functions do not work well it adversely affect the the static and dynamic balance of standing. When the literature is examined, it is seen that there is limited research on the balance problems and exercises of the hearing impaired.
- Being tested
- exercise
- Keywords
- balance, gait, deaf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
- Static exercises and dynamic exercises to group 2; Hearing impaired children in group 3 will be given motor-motor double-task and motor-cognitive double-task exercises in addition to conventional balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control (Group 1) | No intervention | Only assessments and scales will be applied to the participants in Group 1 at the beginning of the study and at the end of 12 weeks. |
| Conventional Exercise Balance (Group 2) | Experimental | Group 2 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Receives: Other: exercise |
| Dual Task-Oriented Stroboscopic Visual Training Group (Group 3) | Experimental | Group 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Trainings are planned with one-on-one therapist. Receives: Other: exercise |
| Healthy Control Group (Group 4) | No intervention | Only assessments and scales will be applied to the participants in Group 4 at the beginning of the study and at the end of 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance
Static balance test to evaluate balance; Flamingo Balance Test
Measured: 12 week
Static balance-2
Static balance test to evaluate balance; Romberg
Measured: 12 week
Dynamic Balance
Dynamic Balance Test; Four Step Square Test (DAKT)
Measured: 12 week
Dynamic Balance-2
Dynamic Balance Test; Functional Reach Test
Measured: 12 week
Balance
Pediatric Berg Balance Scale; This is a 14 item test. Ranging from 0 (with help) to 4 (Normal), Maximum 56 Point.
Measured: 12 week
Functional Mobility
Timed Up and Go Test
Measured: 12 week
Gait
10 meters Walk Test
Measured: 12 week
Functional Gait
Functional Gait Assessment; This is a 10 item test. from 0 (Severe) to 3 (Normal), Maximum 30 Point.
Measured: 12 week
Fall
Fall History Survey
Measured: 12 week
Fear of Falling
Tinetti; This is a 10 item test. Raging from 1 (not safe) to 10 (extremely safe). Maximum 100 Point.
Measured: 12 week
Hand-Eye Coordination
9 Hole Peg Test
Measured: 12 week
Life Quality
The Generic Children's Health Related Quality of Life Questionnare(Kid-KINDL); Kid-KINDL items are answered on a 5-point Likert-type scale, ranging from 1 (never) to 5 (always). Some items (1, 2, 3, 6, 7, 8, 15, 16, 20, and 24. items) with a negative orientation needed to be reverse coded, depending on the statement.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 May 2022
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Responsible party
- Principal investigator, HAFİZA GÖZEN, University of Gaziantep
- Investigators
- Hafiza Gözen, Principal investigator, https://akbis.gantep.edu.tr/detay/?A_ID=187586_ogr-gor_hafiza-gozenSerkan Usgu, Study director, https://profil.hku.edu.tr/akademik/serkan-usgu/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404126
- Sponsor's protocol ID
- hgözen
- Acronym
- Balance
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nvestigation of the Effect of Dual-Task Focused Stroboscopic Visual Education on Balance and Gait in Hearing Impaired Children
- ClinicalTrials.gov ID
- NCT05404126
- Acronym / sponsor ID
- Balance / hgözen
- Keywords
- balance, gait, deaf
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Collaborators
- Hasan Kalyoncu University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 3 Jun 2022 (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.
The investigators balance and balance related problems and exercise programs should be handled multi-dimensionally. In this study, the investigators' aim is to investigate the effect of dual task-oriented education with stroboscopic glasses on balance, functional mobility and general walking parameters in children with hearing impairment, despite conventional balance exercises.
The study will be started when the consent form which prepared in accordance with the ethical committee conditions, explained and approved to all participants and their families. Participants aged 7-12 years, who have not undergone cochlear implant surgery, who can walk independently, have a hearing threshold of 75 decibels (dB) and above, and are diagnosed with congenital bilateral sensorineural hearing impairment will be included in the study. Hearing impaired children who have physical, visual impairment, lack of cooperation for the application and have any neurological problems (other than sensorineural hearing loss) or orthopedic problems that may affect their balance will not be included. Children who meet the inclusion criteria will be divided into three groups by block randomization method; as control (Group 1), conventional exercise balance (Group 2), dual task-oriented stroboscopic visual training group (Group 3) and a healthy control group (Group 4) without any disability will form the fourth group. Only assessments and scales will be applied to the participants in Group 1 and Group 4 at the beginning of the study and at the end of 12 weeks. Group 2 and Group 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Conventional balance exercises are planned to be done in groups, and other trainings are planned with one-on-one therapist. Before starting exercise training, demographic characteristics such as dB values (specified in the health reports of), age (years), height (cm), body weight (kg) of the children included in the study will be recorded. At the beginning of the exercise training and at the end of the 12-week training; balance, functional mobility and gait, fall history and fear of falling, quality of life, hand-eye coordination will be evaluated.
This study is important in terms of being an example for researches to be carried out for the hearing impaired or other disability groups and contributing to the exercise programs of the trainers working in this field.
Detailed description
One of the important problem in individuals with congenital hearing impairment is the functional insufficiency of the balance centers that work in conjunction with each other because they cannot perceive auditorily external stimuli. Although the visual perceptions, proprioceptors and antigravity muscles work well,if vestibular system functions do not work well it adversely affect the the static and dynamic balance of standing. When the literature is examined, it is seen that there is limited research on the balance problems and exercises of the hearing impaired.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control (Group 1) | No intervention | –Only assessments and scales will be applied to the participants in Group 1 at the beginning of the study and at the end of 12 weeks. |
| Conventional Exercise Balance (Group 2) | Experimental | Other: exerciseGroup 2 will be included in the exercise program twice a week for 40 minutes for 12 weeks. |
| Dual Task-Oriented Stroboscopic Visual Training Group (Group 3) | Experimental | Other: exerciseGroup 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Trainings are planned with one-on-one therapist. |
| Healthy Control Group (Group 4) | No intervention | –Only assessments and scales will be applied to the participants in Group 4 at the beginning of the study and at the end of 12 weeks. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- In Hearing Impaired Groups
- Between the ages of 7-12,
- Not undergoing cochlear implant surgery,
- Able to walk independently,
- Having a hearing threshold of 71 decibels (dB) and above according to the hearing test,
Key exclusion criteria (7 listed)
- In Hearing Impaired Groups
- In addition, having any physical or visual disability,
- Lack of cooperation for the application,
- Volunteers with a neurological or any orthopedic problem other than sensorinoral hearing loss that may affect their balance.
- In the Healthy Group
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 |
|---|---|---|
| exercise• Static exercises and dynamic exercises to group 2; Hearing impaired children in group 3 will be given motor-motor double-task and motor-cognitive double-task exercises in addition to conventional balance exercises. | Other | Conventional Exercise Balance (Group 2), Dual Task-Oriented Stroboscopic Visual Training Group (Group 3) |
Primary outcome
Static balance
Time frame: 12 week
Static balance test to evaluate balance; Flamingo Balance Test
Static balance-2
Time frame: 12 week
Static balance test to evaluate balance; Romberg
Dynamic Balance
Time frame: 12 week
Dynamic Balance Test; Four Step Square Test (DAKT)
Dynamic Balance-2
Time frame: 12 week
Dynamic Balance Test; Functional Reach Test
Balance
Time frame: 12 week
Pediatric Berg Balance Scale; This is a 14 item test. Ranging from 0 (with help) to 4 (Normal), Maximum 56 Point.
Functional Mobility
Time frame: 12 week
Timed Up and Go Test
Gait
Time frame: 12 week
10 meters Walk Test
Functional Gait
Time frame: 12 week
Functional Gait Assessment; This is a 10 item test. from 0 (Severe) to 3 (Normal), Maximum 30 Point.
Fall
Time frame: 12 week
Fall History Survey
Fear of Falling
Time frame: 12 week
Tinetti; This is a 10 item test. Raging from 1 (not safe) to 10 (extremely safe). Maximum 100 Point.
Hand-Eye Coordination
Time frame: 12 week
9 Hole Peg Test
Life Quality
Time frame: 12 week
The Generic Children's Health Related Quality of Life Questionnare(Kid-KINDL); Kid-KINDL items are answered on a 5-point Likert-type scale, ranging from 1 (never) to 5 (always). Some items (1, 2, 3, 6, 7, 8, 15, 16, 20, and 24. items) with a negative orientation needed to be reverse coded, depending on the statement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Balance
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Not yet recruitingObservational study
Isokinetic Knee Strength, Bilateral Muscle Balance, and Anaerobic Performance in Adolescent Athletes
Isokinetic Knee Strength, Hamstring-to-Quadriceps Strength Ratio
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.
Hafiza Gözen principal investigator
https://akbis.gantep.edu.tr/detay/?A_ID=187586_ogr-gor_hafiza-gozen
Serkan Usgu study director
https://profil.hku.edu.tr/akademik/serkan-usgu/
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Balance and Gait, run by University of Gaziantep 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Jun 2022. 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?
Results are not available in the source record.
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?
Static balance (time frame: 12 week). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2022.