Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114487
Recruitment Status : Active, not recruiting
First Posted : October 3, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Istanbul Medipol University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cognitive Rehabilitation Other: dual task balance training Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.
Other: dual task balance training
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 Name: classic balance training

Experimental: intervention
In theintervention group, dual task balance training will be applied within the scope of cognitive rehabilitation.
Other: dual task balance training
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 Name: classic balance training




Primary Outcome Measures :
  1. 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. )


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114487


Locations
Layout table for location information
Turkey
Ebrar Atak
Yalova, Turkey, 77100
Sponsors and Collaborators
Istanbul Medipol University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ebrar Atak, MSc Gerçek Dünya special education and rehabilitation center
  Study Documents (Full-Text)

Documents provided by Istanbul Medipol University Hospital:
Informed Consent Form  [PDF] December 21, 2018
Study Protocol  [PDF] December 21, 2018


Layout table for additonal information
Responsible Party: Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT04114487    
Other Study ID Numbers: ebraratak
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istanbul Medipol University Hospital:
Cognitive rehabilitation
Dual task
Balance
Motor skills