BlindnessNCT06318000
Physical Activity and Sports for People With Visual Impairments
An observational study of Blindness and Visual Impairment, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial summary
Purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Blindness, Visual Impairment
- What is being tested?
- Balance test, bilateral coordination test, fundamental motor skills test
- How many people
- 76 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2020to 31 Dec 2022
- 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 7 to 17 years
- All sexes
- Child
Study population: Participants were 51 individuals with congenital or acguired visual impairments (26 girls and 25 boys) aged 7 to 17. The group of able-bodied peers consisted of 25 individuals (13 girls and 12 boys).
Who may be able to join
- written consent form,
- visual impairment (diagnosed)
- intellectual norm.
Who cannot join
- nervous system disorders,
- structural changes within the musculoskeletal system
- and intellectual limitations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Relationship Between the Visual Impairment Degree and the Level of Children's Fundamental Motor Skills, Balance and Bilateral Coordination
Purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination.
Read the detailed description
The participants were presented with the procedure of the study and informed that they could resign from their participation in the study at any stage. All participants legal guardians, were given the written informed consent form after the detailed written explanation of the risk and benefits resulting from participation in this study. Static balance was assessed using the portable AccuSway-Optimized (ACS-O) by AMTI stabilographic platform (ACS Model). The study participants performed the both feet 30 second, single 10 second left and right-leg stance with eyes open (EO), and both feet 30 second, left and right-leg stance with eyes closed (EC). If the first attempt was not successful, study participants were able to do the second attempt. The tests were conducted approximately 2 hours after a meal, in a sports outfit, in a specially designated room.
The functional assessment of locomotor skills will utilize the "locomotion" subtest, which is part of the Test of Gross Motor Development, Second Edition (TGMD-3) battery. In the selected "locomotion" subtest, the following movement tasks (locomotor skills) are assessed: Run, Gallop, Hop, Horizontal Jump, Skip, Slide.
The subtest 4 "Bilateral Coordination" of the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) was used in this study. The BOT-2 is an individually administered test that includes goal-directed activities to measure a wide range of motor skills in individuals aged 4 to 21 years. Participants performed seven items:
- Touching Nose with Index Fingers - Eyes Closed
- Jumping Jacks
- Jumping in Place - Same Sides Synchronized
- Jumping in Place - Opposite Sides
- Pivoting Thumbs and Index Fingers
- Tapping Feet and Fingers - Same Sides Synchronized
- Tapping Feet and Fingers - Opposite Sides
- Conditions
- Blindness, Visual Impairment
- Being tested
- Balance test, bilateral coordination test, fundamental motor skills test
- Keywords
- Balance, Fundamental Motor Skills, Bilateral Coordination, Visual Impairments
- 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.
Balance test, bilateral coordination test, fundamental motor skills testOther
Functional assessment
| Study group | Role | What they receive |
|---|---|---|
| Persons with visual impairments | Youth aged 7-17 years, male and female, with congenital or acquired visual impairment Receives: Other: Balance test, bilateral coordination test, fundamental motor skills test | |
| Able bodied persons | Youth aged 7-17 years, male and female, without impairments Receives: Other: Balance test, bilateral coordination test, fundamental motor skills test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of pressure (CoP) path length was measured
CoP displacement analysis is used to assess postural sway, based on which the balance control function can be assessed
Measured: Baseline
Surface area of stabilogram was measured
Based on the analysis of the surface area of the stabilogram, the level of balance control can be assessed
Measured: Baseline
Raw and scale score for each item
Based on this information, the level of bilateral coordination can be assessed. The assessment consists of 12 elements, with 6 aimed at assessing locomotion skills and the remaining 6 at object control skills. The locomotion component includes running, galloping, hopping, skipping, jumping, and sliding. The object control component includes striking stationary ball, stationary dribbling, catching, kicking, striking moving ball, and rolling ball. Each task is performed twice, with 1 point awarded for correct execution and 0 points for incorrect execution in every task's criteria. The total score from both trials indicates the final score for each task.
Measured: Baseline
Qualitative performance criteria (points)
Based on this information, the level of fundamental motor skills level can be assessed. Raw score for each item was converted into point score rated on a scale of 0 to 3 or 4 points, in accordance to the study protocol, and the standardization of the test described in the manual of the BOT-2. The sum of raw scores from all the 7 items ranged from 0 to 24 points. The scale score was used to describe the examinee's level of proficiency on the subtest 4. Higher scores mean a better outcome.
Measured: Baseline
Secondary outcomes (2)
Body mass in kg
body mass
Measured: Baseline
Body height in cm
height
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Mar 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlindnessStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Morgulec - Adamowicz, Prof, Study director, Józef Piłsudski University of Physical Education in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318000
- Sponsor's protocol ID
- SN4/20/22
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationship Between the Visual Impairment Degree and the Level of Children's Fundamental Motor Skills, Balance and Bilateral Coordination
- ClinicalTrials.gov ID
- NCT06318000
- Acronym / sponsor ID
- SN4/20/22
- Conditions
- Blindness, Visual Impairment
- Keywords
- Balance, Fundamental Motor Skills, Bilateral Coordination, Visual Impairments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Mar 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.
Purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination.
Detailed description
The participants were presented with the procedure of the study and informed that they could resign from their participation in the study at any stage. All participants legal guardians, were given the written informed consent form after the detailed written explanation of the risk and benefits resulting from participation in this study. Static balance was assessed using the portable AccuSway-Optimized (ACS-O) by AMTI stabilographic platform (ACS Model). The study participants performed the both feet 30 second, single 10 second left and right-leg stance with eyes open (EO), and both feet 30 second, left and right-leg stance with eyes closed (EC). If the first attempt was not successful, study participants were able to do the second attempt. The tests were conducted approximately 2 hours after a meal, in a sports outfit, in a specially designated room.
The functional assessment of locomotor skills will utilize the "locomotion" subtest, which is part of the Test of Gross Motor Development, Second Edition (TGMD-3) battery. In the selected "locomotion" subtest, the following movement tasks (locomotor skills) are assessed: Run, Gallop, Hop, Horizontal Jump, Skip, Slide.
The subtest 4 "Bilateral Coordination" of the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) was used in this study. The BOT-2 is an individually administered test that includes goal-directed activities to measure a wide range of motor skills in individuals aged 4 to 21 years. Participants performed seven items:
- Touching Nose with Index Fingers - Eyes Closed
- Jumping Jacks
- Jumping in Place - Same Sides Synchronized
- Jumping in Place - Opposite Sides
- Pivoting Thumbs and Index Fingers
- Tapping Feet and Fingers - Same Sides Synchronized
- Tapping Feet and Fingers - Opposite Sides
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persons with visual impairments | – | Other: Balance test, bilateral coordination test, fundamental motor skills testYouth aged 7-17 years, male and female, with congenital or acquired visual impairment |
| Able bodied persons | – | Other: Balance test, bilateral coordination test, fundamental motor skills testYouth aged 7-17 years, male and female, without impairments |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Participants were 51 individuals with congenital or acguired visual impairments (26 girls and 25 boys) aged 7 to 17. The group of able-bodied peers consisted of 25 individuals (13 girls and 12 boys).
Key inclusion criteria (3 listed)
- written consent form,
- visual impairment (diagnosed)
- intellectual norm.
Key exclusion criteria (3 listed)
- nervous system disorders,
- structural changes within the musculoskeletal system
- and intellectual limitations.
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 test, bilateral coordination test, fundamental motor skills testFunctional assessment | Other | Able bodied persons, Persons with visual impairments |
Primary outcome
Center of pressure (CoP) path length was measured
Time frame: Baseline
CoP displacement analysis is used to assess postural sway, based on which the balance control function can be assessed
Surface area of stabilogram was measured
Time frame: Baseline
Based on the analysis of the surface area of the stabilogram, the level of balance control can be assessed
Raw and scale score for each item
Time frame: Baseline
Based on this information, the level of bilateral coordination can be assessed. The assessment consists of 12 elements, with 6 aimed at assessing locomotion skills and the remaining 6 at object control skills. The locomotion component includes running, galloping, hopping, skipping, jumping, and sliding. The object control component includes striking stationary ball, stationary dribbling, catching, kicking, striking moving ball, and rolling ball. Each task is performed twice, with 1 point awarded for correct execution and 0 points for incorrect execution in every task's criteria. The total score from both trials indicates the final score for each task.
Qualitative performance criteria (points)
Time frame: Baseline
Based on this information, the level of fundamental motor skills level can be assessed. Raw score for each item was converted into point score rated on a scale of 0 to 3 or 4 points, in accordance to the study protocol, and the standardization of the test described in the manual of the BOT-2. The sum of raw scores from all the 7 items ranged from 0 to 24 points. The scale score was used to describe the examinee's level of proficiency on the subtest 4. Higher scores mean a better outcome.
2 secondary outcomes
Body mass in kg
Time frame: Baseline
Body height in cm
Time frame: Baseline
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 20 Mar 2024.
- Role of vision in static balance in persons with and without visual impairmentsLink provided by the sponsor.
- Description Effects of sport on static balance in athletes with visual impairmentsLink provided by the sponsor.
- Test of Motor Proficiency Second Edition (BOT-2): Compatibility of the Complete and Short Form and Its Usefulness for Middle-Age School ChildrenLink provided by the sponsor.
- Test of Gross Motor Development - 3Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Natalia Morgulec - Adamowicz, Prof study director
Józef Piłsudski University of Physical Education in Warsaw
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 and Visual Impairment, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 20 Mar 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 Poland. 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?
Center of pressure (CoP) path length was measured (time frame: Baseline). The study lists 4 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 20 Mar 2024.