Children with Low VisionNCT05917457
Investigation of the Effects of Balance Coordination and Strengthening Training on Gait, Mobility and Posture in Children with Low Vision
A study testing balance coordination and strengthening training in people with Children with Low Vision, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this research is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision The hypotheses of our study: H1: Balance coordination and strengthening training has an effect on gait, mobility and posture in children with low… Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Children with Low Vision
- What is being tested?
- balance coordination and strengthening training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2022to 20 Mar 2023
- Phase
- Interventional
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To be in the age December of 7-14,
- Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease,
- Having been diagnosed with low vision,
- To be able to establish cooperation,
- Volunteering to participate in the study
Who cannot join
- Not being diagnosed with low vision,
- Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) having an additional disease,
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kınıklı Campus, Üniversite St. No:11 20160 Pamukkale / DENİZLİ
Denizli, Pamukkale, 20000
About this study
Official title: Investigation of the Effects of Balance Coordination and Reinforcement Training on Gait, Mobility and Posture in Children with Low Vision
The aim of this research is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision
The hypotheses of our study:
H1: Balance coordination and strengthening training has an effect on gait, mobility and posture in children with low vision.
H2: Balance coordination and strengthening training has no effect on gait, mobility and posture in children with low vision.
Read the detailed description
The aim of this study is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision.
A total of 22 low-vision individuals were included in the study. Individuals were randomly divided into two groups as Control (n=10) and Study (n=12). The treatment group received 70 min balance (20 min), coordination (20 min) and strengthening (20 min) training 3 days a week for 8 weeks. No additional treatment was applied to the control group. Evaluations were performed before treatment and at the end of 8 weeks.
In the evaluations; Bruininks-Oseretsky Motor Proficiency Test 2 Short Form (BOT2- KF), New York Posture Analysis, Manual November muscle strength assessment, G-Walk Gait Analysis, Independent Mobility Questionnaire (BMA) were used.
- Conditions
- Children with Low Vision
- Being tested
- balance coordination and strengthening training
- Keywords
- Low vision, visually impaired, balance, strength training, walking
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance coordination and strengthening trainingOther
The 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group.
Study group: Low vision children were given balance, coordination training and general strengthening training with sandbags for 70 minutes 3 days a week (5-minute warm-up phase, 20-minute balance training, 20-minute coordination training, 20-minute strengthening training and 5-minute cooling phase) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 12 children with these criteria Receives: Other: balance coordination and strengthening training |
| control group | No intervention | to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 10 children with these criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of motor competence
The Bruininks- Oseretsky Motor Proficiency Test Short Form was used to evaluate motor competence in the cases.
Measured: 8 weeks
posture analysis
New York Posture Analysis was used to evaluate postures of the cases.
Measured: 8 weeks
muscle strength assessment
The Lovett method was used for the muscle strength
Measured: 8 weeks
Evaluation of Walking Parameters
G-Walk system was used
Measured: 8 weeks
Mobility Level Assessment
Independent Mobility Questionnaire (IMQ) was used
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start20 Nov 2022
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children with Low VisionStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Criteria for Inclusion of Volunteers in the Study and Control Group in the Research: to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease October, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study The 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Server ERDOĞMUŞ, Pamukkale University
- Investigators
- ERDOĞAN KAVLAK, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917457
- Sponsor's protocol ID
- Children with Low Vision
- Status last verified
- Mar 2025
- First submitted
- 29 May 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Treatment group: Children with low vision will be given balance, coordination training and strengthening with sandbags for 75 minutes 3 days a week, for 8 weeks. 2. Control Group: No training will be given except for evaluations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Balance Coordination and Reinforcement Training on Gait, Mobility and Posture in Children with Low Vision
- ClinicalTrials.gov ID
- NCT05917457
- Acronym / sponsor ID
- Children with Low Vision
- Conditions
- Children with Low Vision
- Keywords
- Low vision, visually impaired, balance, strength training, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 23 Jun 2023 (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 research is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision
The hypotheses of our study:
H1: Balance coordination and strengthening training has an effect on gait, mobility and posture in children with low vision.
H2: Balance coordination and strengthening training has no effect on gait, mobility and posture in children with low vision.
Detailed description
The aim of this study is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision.
A total of 22 low-vision individuals were included in the study. Individuals were randomly divided into two groups as Control (n=10) and Study (n=12). The treatment group received 70 min balance (20 min), coordination (20 min) and strengthening (20 min) training 3 days a week for 8 weeks. No additional treatment was applied to the control group. Evaluations were performed before treatment and at the end of 8 weeks.
In the evaluations; Bruininks-Oseretsky Motor Proficiency Test 2 Short Form (BOT2- KF), New York Posture Analysis, Manual November muscle strength assessment, G-Walk Gait Analysis, Independent Mobility Questionnaire (BMA) were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Criteria for Inclusion of Volunteers in the Study and Control Group in the Research: to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease October, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study The 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Other: balance coordination and strengthening trainingto be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 12 children with these criteria |
| control group | No intervention | –to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 10 children with these criteria |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- To be in the age December of 7-14,
- Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease,
- Having been diagnosed with low vision,
- To be able to establish cooperation,
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Not being diagnosed with low vision,
- Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) having an additional disease,
- Not volunteering to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balance coordination and strengthening trainingThe 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group. Study group: Low vision children were given balance, coordination training and general strengthening training with sandbags for 70 minutes 3 days a week (5-minute warm-up phase, 20-minute balance training, 20-minute coordination training, 20-minute strengthening training and 5-minute cooling phase) for 8 weeks. | Other | treatment group |
Primary outcome
Evaluation of motor competence
Time frame: 8 weeks
The Bruininks- Oseretsky Motor Proficiency Test Short Form was used to evaluate motor competence in the cases.
posture analysis
Time frame: 8 weeks
New York Posture Analysis was used to evaluate postures of the cases.
muscle strength assessment
Time frame: 8 weeks
The Lovett method was used for the muscle strength
Evaluation of Walking Parameters
Time frame: 8 weeks
G-Walk system was used
Mobility Level Assessment
Time frame: 8 weeks
Independent Mobility Questionnaire (IMQ) was used
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 27 Mar 2025.
- Individual participant dataSharing planned: Yes. 1. Treatment group: Children with low vision will be given balance, coordination training and strengthening with sandbags for 75 minutes 3 days a week, for 8 weeks. 2. Control Group: No training will be given except for evaluations.
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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.
ERDOĞAN KAVLAK study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance coordination and strengthening training in people with Children with Low Vision, run by Pamukkale 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 5 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 27 Mar 2025. 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?
Evaluation of motor competence (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2025.