- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05917457
Investigation of the Effects of Balance Coordination and Strengthening Training on Gait, Mobility and Posture in Children With Low Vision
Investigation of the Effects of Balance Coordination and Reinforcement Training on Gait, Mobility and Posture in Children With Low Vision
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pamukkale
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Denizli, Pamukkale, Turkey, 20000
- Kınıklı Campus, Üniversite St. No:11 20160 Pamukkale / DENİZLİ
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment group
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
|
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. |
No Intervention: control group
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of motor competence
Time Frame: 8 weeks
|
The Bruininks- Oseretsky Motor Proficiency Test Short Form was used to evaluate motor competence in the cases.
|
8 weeks
|
posture analysis
Time Frame: 8 weeks
|
New York Posture Analysis was used to evaluate postures of the cases.
|
8 weeks
|
muscle strength assessment
Time Frame: 8 weeks
|
The Lovett method was used for the muscle strength
|
8 weeks
|
Evaluation of Walking Parameters
Time Frame: 8 weeks
|
G-Walk system was used
|
8 weeks
|
Mobility Level Assessment
Time Frame: 8 weeks
|
Independent Mobility Questionnaire (IMQ) was used
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: ERDOĞAN KAVLAK, Pamukkale University
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
- Children with Low Vision
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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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