NCT06461520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

June 16, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

June 11, 2024

Last Update Submit

October 28, 2024

Conditions

Keywords

Hearing LossBalancePediatric balance scaleMaze balance board trainingSWOC test

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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.

Other: Maze Balance boardOther: 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.

Other: Proprioceptive training

Interventions

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.

Maze Balance Board

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.

Maze Balance BoardProprioceptive training

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital Faislabad

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related 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.

    PMID: 10577775BACKGROUND
  • 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.

    PMID: 26468119BACKGROUND
  • 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.

    PMID: 31557539BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syeda Wardah Haroon, MS*

    Riphah International University Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask both groups about treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 17, 2024

Study Start

June 16, 2024

Primary Completion

August 10, 2024

Study Completion

August 20, 2024

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations