Balance and Gait in Hearing Impaired Children

NCT05404126 | Unknown

• 1 other identifier: hgözen
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators balance and balance related problems and exercise programs should be handled multi-dimensionally. In this study, the investigators' aim is to investigate the effect of dual task-oriented education with stroboscopic glasses on balance, functional mobility and general walking parameters in children with hearing impairment, despite conventional balance exercises. The study will be started when the consent form which prepared in accordance with the ethical committee conditions, explained and approved to all participants and their families. Participants aged 7-12 years, who have not undergone cochlear implant surgery, who can walk independently, have a hearing threshold of 75 decibels (dB) and above, and are diagnosed with congenital bilateral sensorineural hearing impairment will be included in the study. Hearing impaired children who have physical, visual impairment, lack of cooperation for the application and have any neurological problems (other than sensorineural hearing loss) or orthopedic problems that may affect their balance will not be included. Children who meet the inclusion criteria will be divided into three groups by block randomization method; as control (Group 1), conventional exercise balance (Group 2), dual task-oriented stroboscopic visual training group (Group 3) and a healthy control group (Group 4) without any disability will form the fourth group. Only assessments and scales will be applied to the participants in Group 1 and Group 4 at the beginning of the study and at the end of 12 weeks. Group 2 and Group 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Conventional balance exercises are planned to be done in groups, and other trainings are planned with one-on-one therapist. Before starting exercise training, demographic characteristics such as dB values (specified in the health reports of), age (years), height (cm), body weight (kg) of the children included in the study will be recorded. At the beginning of the exercise training and at the end of the 12-week training; balance, functional mobility and gait, fall history and fear of falling, quality of life, hand-eye coordination will be evaluated. This study is important in terms of being an example for researches to be carried out for the hearing impaired or other disability groups and contributing to the exercise programs of the trainers working in this field.

Conditions

Balance; Gait

Keywords

balance; gait; deaf

Outcome Measures

Primary Outcomes (12)

• Static balance

  Static balance test to evaluate balance; Flamingo Balance Test

  12 week

• Static balance-2

  Static balance test to evaluate balance; Romberg

  12 week

• Dynamic Balance

  Dynamic Balance Test; Four Step Square Test (DAKT)

  12 week

• Dynamic Balance-2

  Dynamic Balance Test; Functional Reach Test

  12 week

• Balance

  Pediatric Berg Balance Scale; This is a 14 item test. Ranging from 0 (with help) to 4 (Normal), Maximum 56 Point.

  12 week

• Functional Mobility

  Timed Up and Go Test

  12 week

• Gait

  10 meters Walk Test

  12 week

• Functional Gait

  Functional Gait Assessment; This is a 10 item test. from 0 (Severe) to 3 (Normal), Maximum 30 Point.

  12 week

• Fall

  Fall History Survey

  12 week

• Fear of Falling

  Tinetti; This is a 10 item test. Raging from 1 (not safe) to 10 (extremely safe). Maximum 100 Point.

  12 week

• Hand-Eye Coordination

  9 Hole Peg Test

  12 week

• Life Quality

  The Generic Children's Health Related Quality of Life Questionnare(Kid-KINDL); Kid-KINDL items are answered on a 5-point Likert-type scale, ranging from 1 (never) to 5 (always). Some items (1, 2, 3, 6, 7, 8, 15, 16, 20, and 24. items) with a negative orientation needed to be reverse coded, depending on the statement.

  12 week

Study Arms (4)

Control (Group 1)

NO INTERVENTION

Only assessments and scales will be applied to the participants in Group 1 at the beginning of the study and at the end of 12 weeks.

Conventional Exercise Balance (Group 2)

EXPERIMENTAL

Group 2 will be included in the exercise program twice a week for 40 minutes for 12 weeks.

Other: exercise

Dual Task-Oriented Stroboscopic Visual Training Group (Group 3)

EXPERIMENTAL

Group 3 will be included in the exercise program twice a week for 40 minutes for 12 weeks. Trainings are planned with one-on-one therapist.

Other: exercise

Healthy Control Group (Group 4)

NO INTERVENTION

Only assessments and scales will be applied to the participants in Group 4 at the beginning of the study and at the end of 12 weeks.

Interventions

exercise OTHER

• Static exercises and dynamic exercises to group 2; Hearing impaired children in group 3 will be given motor-motor double-task and motor-cognitive double-task exercises in addition to conventional balance exercises.

Conventional Exercise Balance (Group 2); Dual Task-Oriented Stroboscopic Visual Training Group (Group 3)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• In Hearing Impaired Groups
• Between the ages of 7-12,
• Not undergoing cochlear implant surgery,
• Able to walk independently,
• Having a hearing threshold of 71 decibels (dB) and above according to the hearing test,
• Volunteers diagnosed with congenital bilateral sensorineural hearing impairment,
• In the Healthy Group
• Between the ages of 7-12,
• Able to walk independently

You may not qualify if:

• In Hearing Impaired Groups
• In addition, having any physical or visual disability,
• Lack of cooperation for the application,
• Volunteers with a neurological or any orthopedic problem other than sensorinoral hearing loss that may affect their balance.
• In the Healthy Group
• Having any physical, visual or hearing impairment,
• Lack of cooperation for the application.

Sponsors & Collaborators

• University of Gaziantep: lead
• Hasan Kalyoncu University: collaborator

Study Sites (1)

Gaziantep University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hafiza Gözen

  https://akbis.gantep.edu.tr/detay/?A_ID=187586_ogr-gor_hafiza-gozen

  PRINCIPAL INVESTIGATOR

• Serkan Usgu

  https://profil.hku.edu.tr/akademik/serkan-usgu/

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 3, 2022
• Study Start: May 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: January 30, 2023
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)