Effects of Maze Balance Board Training on Balance in Children With Hearing Impairment.

Hearing Impaired Children Clinical Trial

Official title:

Effects of Maze Balance Board Training Program on Balance in Children With Hearing Impairment.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461520
• Other study ID #: REC/RCR&AHS/23/0785
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 16, 2024
• Est. completion date: August 20, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

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.

A randomized controlled trial will be used for this. The study will have ethical committee approval. Following that, patients who meet the inclusion criteria will be included in the study when their informed consent has been obtained. The 36 patients will be split into two groups, and the pediatric balance scale, CTSIB, and SWOC will be used to evaluate each child's balance. The study group will receive the seven-stage maze balance board training three times per day and twice per week, while the control group will undergo a standard 10-week physical therapy program that includes 40 minutes of proprioceptive training for balance three times per week. SPSS 25 will be used to examine the data. We'll compute the mean and standard deviation. An appropriate test will be used to compare the two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: August 20, 2024
• Est. primary completion date: August 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Impaired Children
• Hearing Loss

Intervention

Other:
• Maze Balance board
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 training
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.

Locations

Country	Name	City	State
Pakistan	Children Hospital Faislabad	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline and 8 weeks
Primary	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.	Baseline and 8 weeks
Primary	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.	Baseline and 8 weeks