Blindness CongenitalNCT06687915
Comparison of Balance and Coordination Parameters of Visually Impaired and Healthy Individuals
An observational study of Blindness Congenital, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blindness Congenital
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: In this study, congenitally visually impaired individuals and healthy individuals aged between 18-40 years were included.
Who may be able to join
- 18 years of age or older
- Congenital visual impairment
- Not having any acute or chronic disease other than congenital blindness
Who cannot join
- Having musculoskeletal deformity
- Being involved in a professional sport
- Having received physiotherapy treatment for balance before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Balance and Coordination Between Visually Impaired and Healthy Sedentary Individuals
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.
Read the detailed description
Visually impaired, with all corrections, individuals who have one tenth of the usual visual acuity of the seeing eye, i.e. 20/200 visual acuity or less, or whose visual angle does not exceed 20 degrees are called blind. The meaning of 20/200 is that an individual affected by visual impairment can see from 60 cm, while an individual with normal vision can see from 6 m. Narrow angle of vision means that, despite normal visual acuity, vision is limited only to the centre, 20 degrees, and objects beyond 20 degrees cannot be seen.
Balance depends on the integration of information received from proprioceptive, vestibular and visual sensory systems. It has been observed that visually impaired individuals have problems in postural stability and balance due to insufficient information from the visual system. In this study, it was aimed to compare the balance, coordination and gait parameters of congenitally visually impaired individuals and healthy sedentary individuals.
- Conditions
- Blindness Congenital
- Keywords
- Complete Blindness, Visual Impairments, Posture Balance
- Medical subject headings
- Blindness, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Congenitally blind | Individuals with congenital visual impairment were included in this group. | |
| Healthy | Healthy sedentary individuals were included in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the baseline of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start25 Dec 2022
- Primary completion22 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blindness CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Percin, Bahçeşehir University
- Investigators
- Emine Atıcı, Assoc. Prof., Study director, Okan UniversityAlper Percin, Ph.D., Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687915
- Sponsor's protocol ID
- Study0007
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It can be shared at the request of the researchers.
Publications
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.
PubMed 18292215Chen 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.
PubMed 22180415Gleeson 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.
PubMed 25027444
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Balance and Coordination Between Visually Impaired and Healthy Sedentary Individuals
- ClinicalTrials.gov ID
- NCT06687915
- Acronym / sponsor ID
- Study0007
- Conditions
- Blindness Congenital
- Keywords
- Complete Blindness, Visual Impairments, Posture Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 25 Dec 2022 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Visually impaired, with all corrections, individuals who have one tenth of the usual visual acuity of the seeing eye, i.e. 20/200 visual acuity or less, or whose visual angle does not exceed 20 degrees are called blind. The meaning of 20/200 is that an individual affected by visual impairment can see from 60 cm, while an individual with normal vision can see from 6 m. Narrow angle of vision means that, despite normal visual acuity, vision is limited only to the centre, 20 degrees, and objects beyond 20 degrees cannot be seen.
Balance depends on the integration of information received from proprioceptive, vestibular and visual sensory systems. It has been observed that visually impaired individuals have problems in postural stability and balance due to insufficient information from the visual system. In this study, it was aimed to compare the balance, coordination and gait parameters of congenitally visually impaired individuals and healthy sedentary individuals.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenitally blind | – | –Individuals with congenital visual impairment were included in this group. |
| Healthy | – | –Healthy sedentary individuals were included in this group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In this study, congenitally visually impaired individuals and healthy individuals aged between 18-40 years were included.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Congenital visual impairment
- Not having any acute or chronic disease other than congenital blindness
Key exclusion criteria (3 listed)
- Having musculoskeletal deformity
- Being involved in a professional sport
- Having received physiotherapy treatment for balance before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Berg Balance Test
Time frame: At the baseline of the study
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 18292215Blum 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.
- Background: PubMed 22180415Chen 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.
- Background: PubMed 25027444Gleeson 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.
- Individual participant dataSharing planned: No. It can be shared at the request of the researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine Atıcı, Assoc. Prof. study director
Okan University
Alper Percin, Ph.D. principal investigator
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blindness Congenital, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Test (time frame: At the baseline of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06687915, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.