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Investigation of the Effects of Balance Coordination and Reinforcement Training on Gait, Mobility and Posture in Children With Low Vision

Primary Purpose

Children With Low Vision

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
balance coordination and strengthening training
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children With Low Vision focused on measuring Low vision, visually impaired, balance, strength training, walking

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To be in the age December of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study Exclusion Criteria: Not being diagnosed with low vision, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) having an additional disease, Not volunteering to participate in the study

Sites / Locations

  • Kınıklı Campus, Üniversite St. No:11 20160 Pamukkale / DENİZLİ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment group

control group

Arm Description

to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 12 children with these criteria

to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 10 children with these criteria

Outcomes

Primary Outcome Measures

Evaluation of motor competence
The Bruininks- Oseretsky Motor Proficiency Test Short Form was used to evaluate motor competence in the cases.
posture analysis
New York Posture Analysis was used to evaluate postures of the cases.
muscle strength assessment
The Lovett method was used for the muscle strength
Evaluation of Walking Parameters
G-Walk system was used
Mobility Level Assessment
Independent Mobility Questionnaire (IMQ) was used

Secondary Outcome Measures

Full Information

First Posted
May 29, 2023
Last Updated
June 15, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05917457
Brief Title
Investigation of the Effects of Balance Coordination and Reinforcement Training on Gait, Mobility and Posture in Children With Low Vision
Official Title
Investigation of the Effects of Balance Coordination and Reinforcement Training on Gait, Mobility and Posture in Children With Low Vision
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this research is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision The hypotheses of our study: H1: Balance coordination and strengthening training has an effect on gait, mobility and posture in children with low vision. H2: Balance coordination and strengthening training has no effect on gait, mobility and posture in children with low vision.
Detailed Description
The aim of this study is to examine and evaluate the effects of balance coordination and strengthening training on gait, mobility and posture in children with low vision. A total of 22 low-vision individuals were included in the study. Individuals were randomly divided into two groups as Control (n=10) and Study (n=12). The treatment group received 70 min balance (20 min), coordination (20 min) and strengthening (20 min) training 3 days a week for 8 weeks. No additional treatment was applied to the control group. Evaluations were performed before treatment and at the end of 8 weeks. In the evaluations; Bruininks-Oseretsky Motor Proficiency Test 2 Short Form (BOT2- KF), New York Posture Analysis, Manual November muscle strength assessment, G-Walk Gait Analysis, Independent Mobility Questionnaire (BMA) were used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children With Low Vision
Keywords
Low vision, visually impaired, balance, strength training, walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Criteria for Inclusion of Volunteers in the Study and Control Group in the Research: to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease October, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study The 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group
Masking
None (Open Label)
Masking Description
they knew which groups they were in and the researcher knew where they were too.
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 12 children with these criteria
Arm Title
control group
Arm Type
No Intervention
Arm Description
to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study 10 children with these criteria
Intervention Type
Other
Intervention Name(s)
balance coordination and strengthening training
Intervention Description
The 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group. Study group: Low vision children were given balance, coordination training and general strengthening training with sandbags for 70 minutes 3 days a week (5-minute warm-up phase, 20-minute balance training, 20-minute coordination training, 20-minute strengthening training and 5-minute cooling phase) for 8 weeks.
Primary Outcome Measure Information:
Title
Evaluation of motor competence
Description
The Bruininks- Oseretsky Motor Proficiency Test Short Form was used to evaluate motor competence in the cases.
Time Frame
8 weeks
Title
posture analysis
Description
New York Posture Analysis was used to evaluate postures of the cases.
Time Frame
8 weeks
Title
muscle strength assessment
Description
The Lovett method was used for the muscle strength
Time Frame
8 weeks
Title
Evaluation of Walking Parameters
Description
G-Walk system was used
Time Frame
8 weeks
Title
Mobility Level Assessment
Description
Independent Mobility Questionnaire (IMQ) was used
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be in the age December of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study Exclusion Criteria: Not being diagnosed with low vision, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) having an additional disease, Not volunteering to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ERDOĞAN KAVLAK
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Kınıklı Campus, Üniversite St. No:11 20160 Pamukkale / DENİZLİ
City
Denizli
State/Province
Pamukkale
ZIP/Postal Code
20000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Treatment group: Children with low vision will be given balance, coordination training and strengthening with sandbags for 75 minutes 3 days a week, for 8 weeks. Control Group: No training will be given except for evaluations.
IPD Sharing Time Frame
July 2022-June 2023

Learn more about this trial

Investigation of the Effects of Balance Coordination and Reinforcement Training on Gait, Mobility and Posture in Children With Low Vision

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