- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06318000
Physical Activity and Sports for People With Visual Impairments
Assessment of the Relationship Between the Visual Impairment Degree and the Level of Children's Fundamental Motor Skills, Balance and Bilateral Coordination
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Warsaw, Poland, 00-968
- University of Physical Education
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- written consent form,
- visual impairment (diagnosed)
- intellectual norm.
Exclusion Criteria:
- nervous system disorders,
- structural changes within the musculoskeletal system
- and intellectual limitations.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Persons with visual impairments
Youth aged 7-17 years, male and female, with congenital or acquired visual impairment
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Functional assessment
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Able bodied persons
Youth aged 7-17 years, male and female, without impairments
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Functional assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
|
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
|
Baseline
|
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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.
|
Baseline
|
|
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.
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Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass in kg
Time Frame: Baseline
|
body mass
|
Baseline
|
|
Body height in cm
Time Frame: Baseline
|
height
|
Baseline
|
Collaborators and Investigators
Investigators
- Study Director: Natalia Morgulec - Adamowicz, Prof, Józef Piłsudski University of Physical Education in Warsaw
Publications and helpful links
Helpful Links
- Role of vision in static balance in persons with and without visual impairments
- Description Effects of sport on static balance in athletes with visual impairments
- Test of Motor Proficiency Second Edition (BOT-2): Compatibility of the Complete and Short Form and Its Usefulness for Middle-Age School Children
- Test of Gross Motor Development - 3
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SN4/20/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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