Visual Impairment Clinical Trial
Official title:
Assessment of the Relationship Between the Visual Impairment Degree and the Level of Children's Fundamental Motor Skills, Balance and Bilateral Coordination
NCT number | NCT06318000 |
Other study ID # | SN4/20/22 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | December 31, 2022 |
Verified date | February 2024 |
Source | Józef Pilsudski University of Physical Education |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility | Inclusion Criteria: - written consent form, - visual impairment (diagnosed) - intellectual norm. Exclusion Criteria: - nervous system disorders, - structural changes within the musculoskeletal system - and intellectual limitations. |
Country | Name | City | State |
---|---|---|---|
Poland | University of Physical Education | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Józef Pilsudski University of Physical Education |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Baseline | |
Primary | 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 | Baseline | |
Primary | 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. | Baseline | |
Primary | 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. | Baseline | |
Secondary | Body mass in kg | body mass | Baseline | |
Secondary | Body height in cm | height | Baseline |
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