NCT05404126: Balance

Balance and Gait in Hearing Impaired Children

Status unknown NA Last updated 3 June 2022

What this trial tests

NA trial testing exercise in Balance in 40 participants. Status unknown.

Timeline

1 May 2022

Primary endpoint
30 July 2022

30 January 2023

Quick facts

Lead sponsor	University of Gaziantep
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 May 2022
Primary completion	30 July 2022
Estimated completion	30 January 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• exercise

Conditions studied

• Balance — all drugs for Balance →
• Gait — all drugs for Gait →

Sponsor

University of Gaziantep

Who can join

Adults 7 to 12, any sex, with Balance or Gait. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Dual-Task Stroboscopic Visual Training on Balance, Functional Mobility, and Gait in Children Who Are Hard-of-Hearing: A Exploratory Randomized Controlled Study.
   Gözen H, Usgu S, Yakut Y. · · 2025 · PMID 41464638 · DOI 10.3390/jcm14248736