NCT04114487

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 31, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

August 6, 2019

Last Update Submit

May 5, 2021

Conditions

Keywords

Cognitive rehabilitationDual taskBalanceMotor skills

Outcome Measures

Primary Outcomes (1)

  • cognitive functions

    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 Outcomes (1)

  • motor functions

    3 months

Study Arms (3)

control 1

NO INTERVENTION

The control 1 group will not be subjected to any application except education.

control 2

ACTIVE COMPARATOR

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

intervention

EXPERIMENTAL

In theintervention group, dual task balance training will be applied within the scope of cognitive rehabilitation.

Other: dual task balance training

Interventions

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.

Also known as: classic balance training
control 2intervention

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • IQ 50-79
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebrar Atak

Yalova, 77100, Turkey (Türkiye)

Location

Study Officials

  • Ebrar Atak, MSc

    Gerçek Dünya special education and rehabilitation center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc(PT)

Study Record Dates

First Submitted

August 6, 2019

First Posted

October 3, 2019

Study Start

December 31, 2018

Primary Completion

December 31, 2019

Study Completion

March 30, 2020

Last Updated

May 10, 2021

Record last verified: 2021-05

Locations