Hearing Impaired ChildrenNCT06461520
Effects of Maze Balance Board Training on Balance in Children With Hearing Impairment.
A study testing Maze Balance board and Proprioceptive training in people with Hearing Impaired Children, run by Riphah International University at 1 site in Pakistan.
Trial summary
The majority of children's everyday activities need balance, which is the complex ability to maintain, obtain, or restore the condition of balance of the body when a child is standing still, getting ready to move, or getting ready to stop moving. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Maze Balance board and Proprioceptive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jun 2024to 20 Aug 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of age 5-8yrs with moderate to severe hearing impairment (41-80 decibels )
- Ability to understand the command
- Single leg stance (Screening Test): Putting leg down before 30 sec using arm for balance
- No history of MSK disorder.
Who cannot join
- Children with perceptual or visual deficits
- Children with seizures or epilepsy
- Marked hip and knee flexion contractures
- Serious medical complications
- Children with fixed deformity of both lower limbs and children with surgical interventions, e.g., tendon release
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Children Hospital Faislabad
Faisalabad, Punjab Province, 38000
About this study
Official title: Effects of Maze Balance Board Training Program on Balance in Children With Hearing Impairment.
The majority of children's everyday activities need balance, which is the complex ability to maintain, obtain, or restore the condition of balance of the body when a child is standing still, getting ready to move, or getting ready to stop moving. Integration of several sensory, motor, and biomechanical inputs is necessary for balance. Nonetheless, alterations in certain sensory systems (such as visual, somatosensory, and vestibular) may result in imbalances inside the body. Previous research has demonstrated that children and adolescents with hearing impairments are more likely to experience balance and/or motor deficits as a result of vestibular system damage, which increases their risk of developing motor and balance issues. Additionally, research has demonstrated a link between hearing loss and a higher risk of all-cause death, maybe through physical activity-related factors including balance and mobility. Combining maze control training with traditional physical therapy's proprioceptive exercises tests your balance and improves your stability overall.
Read the detailed description
Balance is the complex ability to retain, achieve, or restore the condition of equilibrium of the body whether a kid is standing still, getting ready to move, or getting ready to stop moving. It is necessary for most of the everyday activities that children engage in. Balance requires the integration of multiple sensory, motor, and biomechanical inputs. However, changes in some sensory systems (visual, somatosensory, vestibular) might lead to internal disequilibrium. Previous studies have shown that vestibular system damage in children and adolescents with hearing impairments increases the likelihood of balance and/or motor deficiencies, which in turn raises the chance of developing motor and balance difficulties. Furthermore, studies have shown a connection between hearing loss and an increased risk of dying from all causes, maybe as a result of elements connected to physical activity, such as mobility and balance. By combining proprioceptive exercises from standard physical therapy with maze control training, you may test your balance and enhance your general stability.
For this, a randomized controlled trial will be employed. The study will be approved by the ethics committee. when that, patients who fulfill the study's inclusion requirements will be included when their informed consent has been obtained. The 36 patients will be divided into two groups, and each child's balance will be assessed using the pediatric balance scale, CTSIB, and SWOC. The control group will participate in a regular 10-week physical therapy program that includes 60 minutes of proprioceptive training for balance two times a week, while the study group will receive the proprioceptive training along-with seven-stage maze balance board training three times per day and twice a week for a total of 60 minutes. The data will be examined for mean and standard deviation using SPSS 25. A suitable assessment will be employed to contrast the two cohorts.
- Conditions
- Hearing Impaired Children
- Being tested
- Maze Balance board, Proprioceptive training
- Keywords
- Hearing Loss, Balance, Pediatric balance scale, Maze balance board training, SWOC test
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maze Balance boardOther
Every child will have their balance evaluated using the SWOC tool, CTSIB, and Pediatric Balance Scale. Patients performed a range of proprioceptive exercises, such as static one-leg standing, board balancing, squatting, and 20 minutes of straight-line walking on a hard surface before moving to a foam surface. For 20 minutes each session, proprioceptive exercises were conducted with open eyes first, followed by closed ones. The training program for the maze balancing board will next take place. There will be seven phases to the maze balance board training; each stage will last for two days and there will be three sessions per day, each lasting an hour.
Proprioceptive trainingOther
This group will get proprioceptive training. For a total of ten weeks, the intervention will be carried out three times a week for forty minutes each. Without maze-balance board training, the training schedule will consist of three sessions each week, lasting ten minutes each for preparatory, twenty minutes for proprioceptive, and ten minutes for restorative activities. Every meeting ended with a 10-minute cool-down and 10-minute warm-up to signify the quality of work.
| Study group | Role | What they receive |
|---|---|---|
| Maze Balance Board | Experimental | Every child will have their balance evaluated using the SWOC tool, CTSIB, and Pediatric Balance Scale. Patients performed a range of proprioceptive exercises, such as static one-leg standing, board balancing, squatting, and 20 minutes of straight-line walking on a hard surface before moving to a foam surface. For 20 minutes each session, proprioceptive exercises were conducted with open eyes first, followed by closed ones. The training program for the maze balancing board will next take place. There will be seven phases to the maze balance board training; each stage will last for two days and there will be three sessions per day, each lasting an hour. Receives: Other: Maze Balance board; Other: Proprioceptive training |
| Proprioceptive training | Active comparator | This group will get proprioceptive training. For a total of ten weeks, the intervention will be carried out three times a week for forty minutes each. Without maze-balance board training, the training schedule will consist of three sessions each week, lasting ten minutes each for preparatory, twenty minutes for proprioceptive, and ten minutes for restorative activities. Every meeting ended with a 10-minute cool-down and 10-minute warm-up to signify the quality of work. Receives: Other: Proprioceptive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale
A modified version of the Berg Balance Scale which is known as the Pediatric Balance Scale is used to evaluate children's functional balance abilities. The 14 items on the scale have a maximum score of 56 points and are rated from 0 (lowest function) to 4 (highest function). It has good inter-rater reliability (ICC=0.997) and test-retest reliability (ICC=0.098). The pediatric balance scale's validity (r=0.797, p <0.05)
Measured: Baseline and 8 weeks
Standardized Walking Obstacle Course (SWOC)
Physical therapists can evaluate a patient's mobility, balance, coordination and functional ability to navigate obstacles using a standardized walking obstacle course tool. The aim is to replicate actual circumstances and obstacles that people might face in their day-to-day pursuits.
For both time and step count, the inter-rater reliability of the SWOC scores was also determined to be extremely high. It was found that for both time and step count, the intra-rater (test-retest) reliability of the SWOC was extremely or very highly reliable. The concurrent validity of the SWOC was investigated by looking at correlations between time and step count on both the TUG and SWOC conditions. With p-values less than 0.003, all Pearson product-moment correlation coefficients were judged significantly.
Measured: Baseline and 8 weeks
Modified Clinical Test of Sensory Interaction in Balance (CTSIB TEST):
The test is a therapist's adaptation of the Computerized Dynamic Posturography, which measures our ability to maintain our balance in the face of gravity by means of our visual, vestibular, and somatosensory interactions. Shumway-Cook and Horak created the exam in 1986, and in 1987, it was further explored as a potential clinical tool. It has been demonstrated that manipulating visual and support surface information causes difficulties for patients with uncompensated unilateral vestibular impairments.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start16 Jun 2024
- Primary completion10 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Model description
- It will be a Randomized Controlled Trial in which non-convenient probability sampling will be used. Two groups of 5-8 yrs age will be formed in which participants will be randomly divided. Group A will undergo maze balance board training for 60 minutes a day twice a week. Group B will undergo proprioceptive training of 40 minutes thrice a week
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syeda Wardah Haroon, MS*, Principal investigator, Riphah International University Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461520
- Sponsor's protocol ID
- REC/RCR&AHS/23/0785
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis A, Hind S. The impact of hearing impairment: a global health problem. Int J Pediatr Otorhinolaryngol. 1999 Oct 5;49 Suppl 1:S51-4. doi: 10.1016/s0165-5876(99)00213-x.
PubMed 10577775Emmett SD, West KP Jr. Nutrition and hearing loss: a neglected cause and global health burden. Am J Clin Nutr. 2015 Nov;102(5):987-8. doi: 10.3945/ajcn.115.122598. Epub 2015 Oct 14. No abstract available.
PubMed 26468119Jafari Z, Kolb BE, Mohajerani MH. Age-related hearing loss and tinnitus, dementia risk, and auditory amplification outcomes. Ageing Res Rev. 2019 Dec;56:100963. doi: 10.1016/j.arr.2019.100963. Epub 2019 Sep 23.
PubMed 31557539
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maze Balance Board Training Program on Balance in Children With Hearing Impairment.
- ClinicalTrials.gov ID
- NCT06461520
- Acronym / sponsor ID
- REC/RCR&AHS/23/0785
- Conditions
- Hearing Impaired Children
- Keywords
- Hearing Loss, Balance, Pediatric balance scale, Maze balance board training, SWOC test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 17 Jun 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.
The majority of children's everyday activities need balance, which is the complex ability to maintain, obtain, or restore the condition of balance of the body when a child is standing still, getting ready to move, or getting ready to stop moving. Integration of several sensory, motor, and biomechanical inputs is necessary for balance. Nonetheless, alterations in certain sensory systems (such as visual, somatosensory, and vestibular) may result in imbalances inside the body. Previous research has demonstrated that children and adolescents with hearing impairments are more likely to experience balance and/or motor deficits as a result of vestibular system damage, which increases their risk of developing motor and balance issues. Additionally, research has demonstrated a link between hearing loss and a higher risk of all-cause death, maybe through physical activity-related factors including balance and mobility. Combining maze control training with traditional physical therapy's proprioceptive exercises tests your balance and improves your stability overall.
Detailed description
Balance is the complex ability to retain, achieve, or restore the condition of equilibrium of the body whether a kid is standing still, getting ready to move, or getting ready to stop moving. It is necessary for most of the everyday activities that children engage in. Balance requires the integration of multiple sensory, motor, and biomechanical inputs. However, changes in some sensory systems (visual, somatosensory, vestibular) might lead to internal disequilibrium. Previous studies have shown that vestibular system damage in children and adolescents with hearing impairments increases the likelihood of balance and/or motor deficiencies, which in turn raises the chance of developing motor and balance difficulties. Furthermore, studies have shown a connection between hearing loss and an increased risk of dying from all causes, maybe as a result of elements connected to physical activity, such as mobility and balance. By combining proprioceptive exercises from standard physical therapy with maze control training, you may test your balance and enhance your general stability.
For this, a randomized controlled trial will be employed. The study will be approved by the ethics committee. when that, patients who fulfill the study's inclusion requirements will be included when their informed consent has been obtained. The 36 patients will be divided into two groups, and each child's balance will be assessed using the pediatric balance scale, CTSIB, and SWOC. The control group will participate in a regular 10-week physical therapy program that includes 60 minutes of proprioceptive training for balance two times a week, while the study group will receive the proprioceptive training along-with seven-stage maze balance board training three times per day and twice a week for a total of 60 minutes. The data will be examined for mean and standard deviation using SPSS 25. A suitable assessment will be employed to contrast the two cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be a Randomized Controlled Trial in which non-convenient probability sampling will be used. Two groups of 5-8 yrs age will be formed in which participants will be randomly divided. Group A will undergo maze balance board training for 60 minutes a day twice a week. Group B will undergo proprioceptive training of 40 minutes thrice a week
| Arm | Type | Receives |
|---|---|---|
| Maze Balance Board | Experimental | Other: Maze Balance board, Other: Proprioceptive trainingEvery child will have their balance evaluated using the SWOC tool, CTSIB, and Pediatric Balance Scale. Patients performed a range of proprioceptive exercises, such as static one-leg standing, board balancing, squatting, and 20 minutes of straight-line walking on a hard surface before moving to a foam surface. For 20 minutes each session, proprioceptive exercises were conducted with open eyes first, followed by closed ones. The training program for the maze balancing board will next take place. There will be seven phases to the maze balance board training; each stage will last for two days and there will be three sessions per day, each lasting an hour. |
| Proprioceptive training | Active comparator | Other: Proprioceptive trainingThis group will get proprioceptive training. For a total of ten weeks, the intervention will be carried out three times a week for forty minutes each. Without maze-balance board training, the training schedule will consist of three sessions each week, lasting ten minutes each for preparatory, twenty minutes for proprioceptive, and ten minutes for restorative activities. Every meeting ended with a 10-minute cool-down and 10-minute warm-up to signify the quality of work. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of age 5-8yrs with moderate to severe hearing impairment (41-80 decibels )
- Ability to understand the command
- Single leg stance (Screening Test): Putting leg down before 30 sec using arm for balance
- No history of MSK disorder.
Key exclusion criteria (5 listed)
- Children with perceptual or visual deficits
- Children with seizures or epilepsy
- Marked hip and knee flexion contractures
- Serious medical complications
- Children with fixed deformity of both lower limbs and children with surgical interventions, e.g., tendon release
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 |
|---|---|---|
| Maze Balance boardEvery child will have their balance evaluated using the SWOC tool, CTSIB, and Pediatric Balance Scale. Patients performed a range of proprioceptive exercises, such as static one-leg standing, board balancing, squatting, and 20 minutes of straight-line walking on a hard surface before moving to a foam surface. For 20 minutes each session, proprioceptive exercises were conducted with open eyes first, followed by closed ones. The training program for the maze balancing board will next take place. There will be seven phases to the maze balance board training; each stage will last for two days and there will be three sessions per day, each lasting an hour. | Other | Maze Balance Board |
| Proprioceptive trainingThis group will get proprioceptive training. For a total of ten weeks, the intervention will be carried out three times a week for forty minutes each. Without maze-balance board training, the training schedule will consist of three sessions each week, lasting ten minutes each for preparatory, twenty minutes for proprioceptive, and ten minutes for restorative activities. Every meeting ended with a 10-minute cool-down and 10-minute warm-up to signify the quality of work. | Other | Maze Balance Board, Proprioceptive training |
Primary outcome
Pediatric Balance Scale
Time frame: Baseline and 8 weeks
A modified version of the Berg Balance Scale which is known as the Pediatric Balance Scale is used to evaluate children's functional balance abilities. The 14 items on the scale have a maximum score of 56 points and are rated from 0 (lowest function) to 4 (highest function). It has good inter-rater reliability (ICC=0.997) and test-retest reliability (ICC=0.098). The pediatric balance scale's validity (r=0.797, p <0.05)
Standardized Walking Obstacle Course (SWOC)
Time frame: Baseline and 8 weeks
Physical therapists can evaluate a patient's mobility, balance, coordination and functional ability to navigate obstacles using a standardized walking obstacle course tool. The aim is to replicate actual circumstances and obstacles that people might face in their day-to-day pursuits. For both time and step count, the inter-rater reliability of the SWOC scores was also determined to be extremely high. It was found that for both time and step count, the intra-rater (test-retest) reliability of the SWOC was extremely or very highly reliable. The concurrent validity of the SWOC was investigated by looking at correlations between time and step count on both the TUG and SWOC conditions. With p-values less than 0.003, all Pearson product-moment correlation coefficients were judged significantly.
Modified Clinical Test of Sensory Interaction in Balance (CTSIB TEST):
Time frame: Baseline and 8 weeks
The test is a therapist's adaptation of the Computerized Dynamic Posturography, which measures our ability to maintain our balance in the face of gravity by means of our visual, vestibular, and somatosensory interactions. Shumway-Cook and Horak created the exam in 1986, and in 1987, it was further explored as a potential clinical tool. It has been demonstrated that manipulating visual and support surface information causes difficulties for patients with uncompensated unilateral vestibular impairments.
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 29 Oct 2024.
- Background: PubMed 10577775Davis A, Hind S. The impact of hearing impairment: a global health problem. Int J Pediatr Otorhinolaryngol. 1999 Oct 5;49 Suppl 1:S51-4. doi: 10.1016/s0165-5876(99)00213-x.
- Background: PubMed 26468119Emmett SD, West KP Jr. Nutrition and hearing loss: a neglected cause and global health burden. Am J Clin Nutr. 2015 Nov;102(5):987-8. doi: 10.3945/ajcn.115.122598. Epub 2015 Oct 14. No abstract available.
- Background: PubMed 31557539Jafari Z, Kolb BE, Mohajerani MH. Age-related hearing loss and tinnitus, dementia risk, and auditory amplification outcomes. Ageing Res Rev. 2019 Dec;56:100963. doi: 10.1016/j.arr.2019.100963. Epub 2019 Sep 23.
- Individual participant dataSharing planned: No
Related trials for Hearing Impaired Children
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Not yet recruiting
Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
Hearing Impaired Children
Recruiting
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Unilateral Hearing Loss, Asymmetric Hearing Loss
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
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.
Syeda Wardah Haroon, MS* principal investigator
Riphah International University Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maze Balance board and Proprioceptive training 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 4 inclusion and 5 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 29 Oct 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: Baseline and 8 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 NCT06461520, which also lists 3 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 29 Oct 2024.