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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2024
Source Józef Pilsudski University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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: 1. Touching Nose with Index Fingers - Eyes Closed 2. Jumping Jacks 3. Jumping in Place - Same Sides Synchronized 4. Jumping in Place - Opposite Sides 5. Pivoting Thumbs and Index Fingers 6. Tapping Feet and Fingers - Same Sides Synchronized 7. Tapping Feet and Fingers - Opposite Sides


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Balance test, bilateral coordination test, fundamental motor skills test
Functional assessment

Locations

Country Name City State
Poland University of Physical Education Warsaw

Sponsors (1)

Lead Sponsor Collaborator
Józef Pilsudski University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

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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