- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04114487
Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded
May 5, 2021 updated by: ebrar atak, Istanbul Medipol University Hospital
With this study, it will be tried to determine whether the addition of physiotherapy program to the education of mentally disabled individuals is effective and necessary in terms of mental performance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Mental disability levels IQ = 50-79 individuals with mild / border mental disabilities will be included in the study.
The disability status of the individuals will be determined by the health report, and the cognitive status of the individuals will be determined by the report given as a result of the evaluation made by the Guidance Research Centers of the National Education Directorates.
The 45-person study group will be randomized to 3 groups of 15 persons each.
The first group will not be subjected to any application except education.
The second group will be the control group and will be taken to the balance training in addition to normal education.
In the third group, dual task balance training will be applied within the scope of cognitive rehabilitation
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Yalova, Turkey, 77100
- Ebrar Atak
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- IQ 50-79
- 6-14 years old
- take command of Turkish
- do not have physical disability
- not have metabolic and systemic disease
- To have a report on the mental disability and education required by the Ministry of National Education
Exclusion Criteria:
- To have any situation that prevents the taking of commands related to the exercise program to be implemented
- To have a chronic systemic disease
- To have an educational diagnosis other than the mental disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control 1
The control 1 group will not be subjected to any application except education.
|
|
|
Active Comparator: control 2
The control 2 group will be the control group and will be taken to the balance training in addition to normal education.
|
The studies were planned to be 2 times a week for 12 weeks.
The 20-minute Dual Task balance training program is planned to be composed of two sections of 10 minutes.
In the first 10 min section, the individual will exercise with the multi-task mode of CogniBoard on the balance ball. .
Stroop study will be performed on the balance ball in the second 10 minutes of the exercise.
Other Names:
|
|
Experimental: intervention
In theintervention group, dual task balance training will be applied within the scope of cognitive rehabilitation.
|
The studies were planned to be 2 times a week for 12 weeks.
The 20-minute Dual Task balance training program is planned to be composed of two sections of 10 minutes.
In the first 10 min section, the individual will exercise with the multi-task mode of CogniBoard on the balance ball. .
Stroop study will be performed on the balance ball in the second 10 minutes of the exercise.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cognitive functions
Time Frame: 3 months
|
short-term memory(visual memory test, memorize the squares,number of correct choices), İnformation processing speed (space bar presses in response to non-target stimulus to be impulsive behavior.
number of errors), Focusing and Perception (space bar presses in response to a target stimulus.The difference between the number of target stimuli that appeared in the test and the number of correct responses gives the number of omission errors.
)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
motor functions
Time Frame: 3 months
|
balance (walking forward a line, number of steps), coordination(jumping in place-same sides synchronized-number of correct form) , manual dexterity(transferring pennies-number of 15 sec.),
gross motor skills and upper-limb coordination (dribling a ball-alternating hands-number of dribbles)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ebrar Atak, MSc, Gerçek Dünya special education and rehabilitation center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 31, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
August 6, 2019
First Submitted That Met QC Criteria
October 2, 2019
First Posted (Actual)
October 3, 2019
Study Record Updates
Last Update Posted (Actual)
May 10, 2021
Last Update Submitted That Met QC Criteria
May 5, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ebraratak
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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