NCT05719610

Brief Summary

Balance and weak postural control are most common in children with severe to profound hearing deficits. Children with hearing deficits also indicate behavioral problems related to impulse control, distraction, and disability to maintain attention in the visual modality. Hearing deficit is mostly defined as a communication deficit. Although the communication deficit is an important disorder, hearing deficit co-occurs with other physical impairments such as vestibular disorders. Development and control of the posture are important prerequisites for skill motor function. Children with hearing deficits and impaired sensory organization had weak balance and motor efficiency in many fields. Various studies on motor skills in deaf children have reported deficits in balance, general dynamic coordination, visual-motor skills, ball catching ability, and some disturbances in reaction time and speed of movements. Teachers of children with hearing impairment often complain of non-coordination, clumsiness, and balance deficit in such children, preventing the child from the desired function. So the aim of the study is to determine the effects of Cawthorne Cooksey Exercises on Balance and quality of life in children with hearing deficit It will be a Randomized Controlled Trial and children fulfilling exclusion-inclusion criteria will participate in the study. They will be divided randomly into two groups, using computer generated randomization, into control group and experimental group. After performing the pre-test measurements, the control group will perform Swiss Ball Exercises for 45 minutes and the interventional group will perform Cawthorne Cooksey Training Program Swiss Ball Exercises in addition, will also perform of 45 min session three times a week for 8 weeks of training. the study subjects will be evaluated again by Pediatrics Berg Balance Scale, Four-Step Square test and Quality of life questionnaire for children to measure the quality of life. Results will be compared with the pretest measurements. Data will be analyzed by using SPSS scale windows software version 25.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

January 31, 2023

Last Update Submit

July 7, 2023

Conditions

Hearing Disorders

Outcome Measures

Primary Outcomes (1)

  • Pediatric Berg Balance Scale

    The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points

    12 weeks

Secondary Outcomes (1)

  • Four-step square test

    12 weeks

Other Outcomes (1)

  • Quality of life questionnaire for children to measure Quality of life

    12 weeks

Study Arms (2)

Cawthorne Cooksey Exercises

EXPERIMENTAL
Other: Cawthorne Cooksey Exercises for Balance Training

Swiss Ball Exercises

EXPERIMENTAL
Other: Swiss Ball Exercises

Interventions

Cawthorne Cooksey Exercises for Balance TrainingOTHER

Group of Exercises used to Increase balance

Cawthorne Cooksey Exercises
Swiss Ball ExercisesOTHER

Swiss Ball Exercises

Swiss Ball Exercises

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with age between 7 to 12 yeas
  • Children with diagnosed sensorineural hearing deficits (PTA \>90db)
  • Children with normal vision

You may not qualify if:

  • Children with any orthopedic and neurological impairments
  • Children taking medications that affect central nervous system
  • In the case of being absent from more than two sessions, non-cooperation of the family, and the occurrence of orthopedic accidents and if diseases prevented the patient from participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Secondary School of Special Education for Deaf, Main Gulberg Lahore.

Lahore, Punjab Province, 50700, Pakistan

Location

MeSH Terms

Conditions

Hearing Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sara Khan, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

January 27, 2023

Primary Completion

June 1, 2023

Study Completion

July 3, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)