NCT06687915

Brief Summary

The aim of this \[observational study\] is to examine balance in multiple aspects by comparing balance, coordination, and gait parameters between congenitally blind individuals and healthy individuals with multiple scales. The main questions it aims to answer are: Is there a difference in balance and coordination between congenitally blind individuals and healthy individuals? comparison group: Healthy sedated individuals Participants will be asked to complete balance scales.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

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

Study Start

First participant enrolled

December 25, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

November 12, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

Complete BlindnessVisual ImpairmentsPosture Balance

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Test

    Berg Balance Scale was developed for postural control assessment. It includes 14 instructions and for each instruction, the patient's performance is observed and a score between 0-4 is given. It takes between 10 and 20 minutes to complete the scale

    At the baseline of the study

Study Arms (2)

Congenitally blind

Individuals with congenital visual impairment were included in this group.

Healthy

Healthy sedentary individuals were included in this group.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

In this study, congenitally visually impaired individuals and healthy individuals aged between 18-40 years were included.

You may qualify if:

  • years of age or older
  • Congenital visual impairment
  • Not having any acute or chronic disease other than congenital blindness

You may not qualify if:

  • Having musculoskeletal deformity
  • Being involved in a professional sport
  • Having received physiotherapy treatment for balance before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avrasya University

Trabzon, Ortahisar, 61000, Turkey (Türkiye)

Location

Related Publications (3)

  • Blum L, Korner-Bitensky N. Usefulness of the Berg Balance Scale in stroke rehabilitation: a systematic review. Phys Ther. 2008 May;88(5):559-66. doi: 10.2522/ptj.20070205. Epub 2008 Feb 21.

    PMID: 18292215BACKGROUND
  • Chen EW, Fu AS, Chan KM, Tsang WW. The effects of Tai Chi on the balance control of elderly persons with visual impairment: a randomised clinical trial. Age Ageing. 2012 Mar;41(2):254-9. doi: 10.1093/ageing/afr146. Epub 2011 Dec 16.

    PMID: 22180415BACKGROUND
  • Gleeson M, Sherrington C, Lo S, Keay L. Can the Alexander Technique improve balance and mobility in older adults with visual impairments? A randomized controlled trial. Clin Rehabil. 2015 Mar;29(3):244-60. doi: 10.1177/0269215514542636. Epub 2014 Jul 15.

    PMID: 25027444BACKGROUND

MeSH Terms

Conditions

BlindnessVision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emine Atıcı, Assoc. Prof.

    Okan University

    STUDY DIRECTOR
  • Alper Percin, Ph.D.

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

December 25, 2022

Primary Completion

July 22, 2023

Study Completion

August 1, 2023

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

It can be shared at the request of the researchers.

Locations