Clinical trial NCT06461520: Effects of Maze Balance Board Training on Balance in Children With Hearing Impairment.
Official title: Effects of Maze Balance Board Training Program on Balance in Children With Hearing Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impaired Children
Keywords: Hearing Loss
Balance
Pediatric balance scale
Maze balance board training
SWOC test
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pediatric Balance Scale
timeFrame: Baseline and 8 weeks
measure: Standardized Walking Obstacle Course (SWOC)
timeFrame: Baseline and 8 weeks
measure: Modified Clinical Test of Sensory Interaction in Balance (CTSIB TEST):
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Children Hospital Faislabad
state: Punjab
Study officials:
affiliation: Riphah International University Lahore
name: Syeda Wardah Haroon, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Emmett 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.
citation: Jafari 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.