DUAL TASKNCT05452135
Cognitive - Motor Dual Task and Swallowing
An observational study of DUAL TASK and DEGLUTİTİON, run by Atılım University.
Trial summary
Swallow and dual-task are a current issue and there are few studies on this subject. These studies have shown that as a result of dual-task interaction, swallowing is affected by attention and cognitive capacity, and dual-task negatively affects swallowing performance. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- DUAL TASK, DEGLUTİTİON, COGNİTİVE FUNCTİON
- What is being tested?
- Observation of visual, audotory and motor reaction time
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2022to 20 Oct 2022
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: aged between 20- 30 healthy young adults.
Who may be able to join
- aged between 20 - 30, being right dominant, be a volunteer to participate study
Who cannot join
- having a neurological disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of Cognitive-Motor Dual Task and Swallowing Interaction in Healthy Young Adults
Swallow and dual-task are a current issue and there are few studies on this subject. These studies have shown that as a result of dual-task interaction, swallowing is affected by attention and cognitive capacity, and dual-task negatively affects swallowing performance. But, studies include simple cognitive tasks and are not suitable for daily living activities. There is no study that compares all visual, auditory and motor dual tasks during swallowing and considers the effects on liquid, thick and solid foods similar to daily living activities. The aim of this study is to determine the effect of visual, auditory and motor dual-task on swallowing and chewing function in healthy young adults. As a result of the study, the dual-task that has the most impact on swallowing and chewing function will be determined, and visual, auditory and motor performance changes will be revealed as well as swallowing and chewing functions. It is planned that the results obtained will guide the rehabilitation of swallowing disorder with further studies on dual-task exercises.
Read the detailed description
For many years, swallowing was thought of as a simple, reflexive activity controlled by the brainstem. However, studies on the neural control of swallowing have shown that cortical and subcortical structures of the nervous system are included in the neural control of swallowing, and swallowing consists of the pre-swallow phase, the oral preparatory phase, aoral phase, pharyngeal phase, and esophageal phase. And swallow prosses tarting with the perception of food.
Physical and chemical properties of the food, environmental factors, and motor, sensory and cognitive factors belonging to a person are effective in the swallowing process. Swallowing is an integral part of our daily life and we perform it together with other functions in our daily life. For example, while watching TV, in meetings, we continue to swallow/eat or drink. Even if we are not aware of swallowing, performing swallow and other functions at the same time. This situation called as "dual-task". 2 tasks performed at the same time always result in a decrease in the performance of one.
Swallow and dual-task are a current issue and there are few studies on this subject.These studies have shown that as a result of dual-task interaction, swallowing is affected by attention and cognitive capacity, and dual-task negatively affects swallowing performance. But, studies include simple cognitive tasks and are not suitable for daily living activities. There is no study that compares all visual, auditory and motor dual tasks during swallowing and considers the effects on liquid, thick and solid foods similar to daily living activities. The aim of this study is to determine the effect of visual, auditory and motor dual-task on swallowing and chewing function in healthy young adults. As a result of the study, the dual-task that has the most impact on swallowing and chewing function will be determined, and visual, auditory and motor performance changes will be revealed as well as swallowing and chewing functions. It is planned that the results obtained will guide the rehabilitation of swallowing disorder with further studies on dual-task exercises.
- Conditions
- DUAL TASK, DEGLUTİTİON, COGNİTİVE FUNCTİON, ACTİVİTİES OF DAİLY LİVİNG
- Being tested
- Observation of visual, audotory and motor reaction time
- Keywords
- DUAL TASK, SWALLOW, COGNİTİVE, MOTOR FUNCTİONS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of visual, audotory and motor reaction timeOther
Also called Dual Task Assessment
Visual, auditory and motor reaction time will be measured as a result of the measurements made during the dual task evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Healty Adults | aged between 20 - 30 years right dominant being a volunteer to participate in the study Receives: Other: Observation of visual, audotory and motor reaction time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Task assessment
Visual, auditory and motor reaction time will be measured as a result of the measurements made during the dual task evaluation.
Measured: 1 day
Swallow assessment
During the dual task task, the dysphagia limit will be determined in liquid and viscous liquids. The maximum amount of water that the person can drink once will be used as the dysphagia limit.
Measured: 2 days
Chewing Assessment
Participants will be asked to eat a 3x4 cm biscuit. Biscuit eating time, number of chewing cycles and number of bites will be calculated.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start20 Jul 2022 (estimated)
- Primary completion20 Aug 2022 (estimated)
- Study completion20 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DUAL TASKStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Selen Serel Arslan, assoc. prof., Study director, Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452135
- Sponsor's protocol ID
- GO 22/417
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Labeit B, Claus I, Muhle P, Regner L, Suntrup-Krueger S, Dziewas R, Warnecke T. Effect of cognitive and motor dual-task on oropharyngeal swallowing in Parkinson's disease. Eur J Neurol. 2021 Mar;28(3):754-762. doi: 10.1111/ene.14603. Epub 2020 Dec 2.
PubMed 33084118Shune SE, Moon JB. Effects of age and non-oropharyngeal proprioceptive and exteroceptive sensation on the magnitude of anticipatory mouth opening during eating. J Oral Rehabil. 2016 Sep;43(9):662-9. doi: 10.1111/joor.12419. Epub 2016 Jul 5.
PubMed 27377757
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Cognitive-Motor Dual Task and Swallowing Interaction in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT05452135
- Acronym / sponsor ID
- GO 22/417
- Conditions
- DUAL TASK, DEGLUTİTİON, COGNİTİVE FUNCTİON, ACTİVİTİES OF DAİLY LİVİNG
- Keywords
- DUAL TASK, SWALLOW, COGNİTİVE, MOTOR FUNCTİONS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (estimated)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 20 Oct 2022 (estimated)
- First posted
- 11 Jul 2022 (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.
Swallow and dual-task are a current issue and there are few studies on this subject. These studies have shown that as a result of dual-task interaction, swallowing is affected by attention and cognitive capacity, and dual-task negatively affects swallowing performance. But, studies include simple cognitive tasks and are not suitable for daily living activities. There is no study that compares all visual, auditory and motor dual tasks during swallowing and considers the effects on liquid, thick and solid foods similar to daily living activities. The aim of this study is to determine the effect of visual, auditory and motor dual-task on swallowing and chewing function in healthy young adults. As a result of the study, the dual-task that has the most impact on swallowing and chewing function will be determined, and visual, auditory and motor performance changes will be revealed as well as swallowing and chewing functions. It is planned that the results obtained will guide the rehabilitation of swallowing disorder with further studies on dual-task exercises.
Detailed description
For many years, swallowing was thought of as a simple, reflexive activity controlled by the brainstem. However, studies on the neural control of swallowing have shown that cortical and subcortical structures of the nervous system are included in the neural control of swallowing, and swallowing consists of the pre-swallow phase, the oral preparatory phase, aoral phase, pharyngeal phase, and esophageal phase. And swallow prosses tarting with the perception of food.
Physical and chemical properties of the food, environmental factors, and motor, sensory and cognitive factors belonging to a person are effective in the swallowing process. Swallowing is an integral part of our daily life and we perform it together with other functions in our daily life. For example, while watching TV, in meetings, we continue to swallow/eat or drink. Even if we are not aware of swallowing, performing swallow and other functions at the same time. This situation called as "dual-task". 2 tasks performed at the same time always result in a decrease in the performance of one.
Swallow and dual-task are a current issue and there are few studies on this subject.These studies have shown that as a result of dual-task interaction, swallowing is affected by attention and cognitive capacity, and dual-task negatively affects swallowing performance. But, studies include simple cognitive tasks and are not suitable for daily living activities. There is no study that compares all visual, auditory and motor dual tasks during swallowing and considers the effects on liquid, thick and solid foods similar to daily living activities. The aim of this study is to determine the effect of visual, auditory and motor dual-task on swallowing and chewing function in healthy young adults. As a result of the study, the dual-task that has the most impact on swallowing and chewing function will be determined, and visual, auditory and motor performance changes will be revealed as well as swallowing and chewing functions. It is planned that the results obtained will guide the rehabilitation of swallowing disorder with further studies on dual-task exercises.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healty Adults | – | Other: Observation of visual, audotory and motor reaction timeaged between 20 - 30 years right dominant being a volunteer to participate in the study |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- aged between 20- 30 healthy young adults.
Key inclusion criteria (1 listed)
- aged between 20 - 30, being right dominant, be a volunteer to participate study
Key exclusion criteria (1 listed)
- having a neurological disease
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 |
|---|---|---|
| Observation of visual, audotory and motor reaction timeAlso: Dual Task AssessmentVisual, auditory and motor reaction time will be measured as a result of the measurements made during the dual task evaluation. | Other | Healty Adults |
Primary outcome
Dual Task assessment
Time frame: 1 day
Visual, auditory and motor reaction time will be measured as a result of the measurements made during the dual task evaluation.
Swallow assessment
Time frame: 2 days
During the dual task task, the dysphagia limit will be determined in liquid and viscous liquids. The maximum amount of water that the person can drink once will be used as the dysphagia limit.
Chewing Assessment
Time frame: 2 days
Participants will be asked to eat a 3x4 cm biscuit. Biscuit eating time, number of chewing cycles and number of bites will be calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 33084118Labeit B, Claus I, Muhle P, Regner L, Suntrup-Krueger S, Dziewas R, Warnecke T. Effect of cognitive and motor dual-task on oropharyngeal swallowing in Parkinson's disease. Eur J Neurol. 2021 Mar;28(3):754-762. doi: 10.1111/ene.14603. Epub 2020 Dec 2.
- Background: PubMed 27377757Shune SE, Moon JB. Effects of age and non-oropharyngeal proprioceptive and exteroceptive sensation on the magnitude of anticipatory mouth opening during eating. J Oral Rehabil. 2016 Sep;43(9):662-9. doi: 10.1111/joor.12419. Epub 2016 Jul 5.
- Individual participant dataSharing planned: Undecided
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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.
Selen Serel Arslan, assoc. prof. study director
Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara, TURKEY
Questions about this trial
What is this clinical trial studying?
An observational study of DUAL TASK and DEGLUTİTİON, run by Atılım University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sena N Begen (+905380929826, sena.begen@atilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual Task assessment (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452135, which also lists 2 linked publications.
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 11 Jul 2022.