NCT06318000

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
Last Updated

March 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

March 1, 2024

Last Update Submit

March 19, 2024

Conditions

Keywords

BalanceFundamental Motor SkillsBilateral CoordinationVisual Impairments

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Body mass in kg

    Baseline

  • Body height in cm

    Baseline

Study Arms (2)

Persons with visual impairments

Youth aged 7-17 years, male and female, with congenital or acquired visual impairment

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

Able bodied persons

Youth aged 7-17 years, male and female, without impairments

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

Interventions

Functional assessment

Able bodied personsPersons with visual impairments

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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).

You may qualify if:

  • written consent form,
  • visual impairment (diagnosed)
  • intellectual norm.

You may not qualify if:

  • nervous system disorders,
  • structural changes within the musculoskeletal system
  • and intellectual limitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Physical Education

Warsaw, 00-968, Poland

Location

Related Links

MeSH Terms

Conditions

BlindnessVision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natalia Morgulec - Adamowicz, Prof

    Józef Piłsudski University of Physical Education in Warsaw

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 19, 2024

Study Start

March 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations