Cognitive RehabilitationNCT04114487
Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded
A study testing dual task balance training in people with Cognitive Rehabilitation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cognitive Rehabilitation
- What is being tested?
- dual task balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2018to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Cognitive Rehabilitation
- Being tested
- dual task balance training
- Keywords
- Cognitive rehabilitation, Dual task, Balance, Motor skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual task balance trainingOther
Also called classic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: dual task balance training |
| intervention | Experimental | In theintervention group, dual task balance training will be applied within the scope of cognitive rehabilitation. Receives: Other: dual task balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. )
Measured: 3 months
Secondary outcomes (1)
motor functions
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start31 Dec 2018
- Primary completion31 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebrar atak, Istanbul Medipol University Hospital
- Investigators
- Ebrar Atak, MSc, Principal investigator, Gerçek Dünya special education and rehabilitation center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114487
- Sponsor's protocol ID
- ebraratak
- Status last verified
- May 2021
- First submitted
- 6 Aug 2019
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded
- ClinicalTrials.gov ID
- NCT04114487
- Acronym / sponsor ID
- ebraratak
- Conditions
- Cognitive Rehabilitation
- Keywords
- Cognitive rehabilitation, Dual task, Balance, Motor skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| control 1 | No intervention | –The control 1 group will not be subjected to any application except education. |
| control 2 | Active comparator | Other: dual task balance trainingThe control 2 group will be the control group and will be taken to the balance training in addition to normal education. |
| intervention | Experimental | Other: dual task balance trainingIn theintervention group, dual task balance training will be applied within the scope of cognitive rehabilitation. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- IQ 50-79
- 6-14 years old
- take command of Turkish
- do not have physical disability
- not have metabolic and systemic disease
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual task balance trainingAlso: classic balance trainingThe 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 | control 2, intervention |
Primary outcome
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. )
1 secondary outcome
motor functions
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebrar Atak, MSc principal investigator
Gerçek Dünya special education and rehabilitation center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual task balance training in people with Cognitive Rehabilitation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive functions (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.