Healthy IndividualsNCT06482528
Effect of Kinesthetic Motor Imagery on Heart Rate, Heart Rate Variability, and Skin Resistance
A study testing Motor Imagery in people with Healthy Individuals, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Motor Imagery (MI) is defined as imagining an action in the mind without any explicit physical movement. MI is considered an "offline" process of the motor areas of the brain. Neuroimaging studies have shown that roughly the same neural structures play a role both during movement execution and MI. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Motor Imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2024to 27 Dec 2024
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18-30 years old
- Volunteering to participate in the study
- Being seemingly healthy
- Not having any neurological or orthopedic disease
- Not having any vision, hearing, or speech problems that would prevent the tests from being performed.
Who cannot join
- Pregnancy and a history of any previous disorder or surgery that alters physical performance or physiological functions
- Have previous experience with Motor Imagery techniques or training
- People being treated with any medication that affects the central nervous system will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
Motor Imagery (MI) is defined as imagining an action in the mind without any explicit physical movement. MI is considered an "offline" process of the motor areas of the brain. Neuroimaging studies have shown that roughly the same neural structures play a role both during movement execution and MI. Specifically, these neural structures; supplementary motor area (SMA), premotor cortex (PMC), and in a growing number of studies, primary motor cortex (M1), inferior parietal lobe (IPL), basal ganglia, and cerebellum. In MI, the changes occurring in the Central Nervous System (CNS), such as the activation of the structures responsible for planning the movement and the purpose for which the movement will be performed, are similar to physical movement, but with the inhibition of the last motor neuron (primary motor area) responsible for revealing the movement, the movement is not physically performed and the motor visualization occurs.
During motor imagery, monitoring the quality of the individual's imagery session is very important for the effectiveness of the session. Additionally, studies have shown that giving the subject biofeedback regarding mental work can modulate the individual's mental work. For these purposes, the quality of an individual's motor imagery during a motor imagery session can be measured by biological measurement methods such as fMRI and autonomic nervous system response. In studies conducted on the autonomic nervous system response, changes in skin resistance and heart rate variations were observed. However, these methods are very costly and cannot be accessed in every clinic. In the literature, the Polar HRV device for measuring heart rate variability is a measuring device with proven validity and reliability and is easily accessible in terms of cost. However, we do not yet know whether Polar HRV is a valid and reliable measurement tool to measure the quality of an individual's imagery session during a motor imagery session.
This study aims to determine the effects of the individual's autonomic nervous system during the kinesthetic motor imagery session. To measure the responses and to investigate whether the polar HRV device is a valid and reliable tool.
Read the detailed description
Motor Imagery (MI) is imagining an action in the mind without any explicit physical movement. MI is considered an "offline" process of the motor areas of the brain. Neuroimaging studies have shown that roughly the same neural structures play a role both during movement execution and MI. Specifically, these neural structures; supplementary motor area (SMA), premotor cortex (PMC), and in a growing number of studies, primary motor cortex (M1), inferior parietal lobe (IPL), basal ganglia, and cerebellum. In MI, the changes occurring in the Central Nervous System (CNS), such as the activation of the structures responsible for planning the movement and the purpose for which the movement will be performed, are similar to physical movement, but with the inhibition of the last motor neuron (primary motor area) responsible for revealing the movement, the movement is not physically performed and the motor visualization occurs.
During motor imagery, monitoring the quality of the individual's imagery session is very important for the session's effectiveness. Additionally, studies have shown that giving the subject biofeedback regarding mental work can modulate the individual's mental work. For these purposes, the quality of an individual's motor imagery during a motor imagery session can be measured by biological measurement methods such as fMRI and autonomic nervous system response. In studies conducted on the autonomic nervous system response, changes in skin resistance and heart rate variations were observed. However, these methods are very costly and cannot be accessed in every clinic. In the literature, the Polar HRV device for measuring heart rate variability is a measuring device with proven validity and reliability and is easily accessible in terms of cost. However, we do not yet know whether Polar HRV is a valid and reliable measurement tool to measure the quality of an individual's imagery session during a motor imagery session.
This study aims to determine the effects of the individual's autonomic nervous system during the kinesthetic motor imagery session. To measure the responses and to investigate whether the polar HRV device is a valid and reliable tool.
- Conditions
- Healthy Individuals
- Being tested
- Motor Imagery
- Keywords
- Imagery, autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor ImageryOther
Also called Relaxation
After the measurement devices are connected to the individuals, they will be seated in a comfortable chair.
After the calibration of the devices, individuals will undergo a 2-minute relaxation session. During the relaxation session, individuals will be asked to focus on their breathing and relax as much as possible.
Then, heart rate variability, electrodermal activities and respiratory frequencies of the individuals will be measured in a sitting position for 5 minutes. In case of rest, after taking the variables, individuals will be kept to rest for 10 minutes.
After 10 minutes, the devices will be placed on the individuals again and a 2-minute relaxation session will be held.
Then, individuals will be asked to imagine running through kinesthetic imagery for 5 minutes.
Feedback will be given to individuals throughout the entire session. These feedbacks will be given verbally with an audio recording prepared by the physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery group | Experimental | Individuals who meet the inclusion criteria will fill out the demographic data form after signing the informed consent form. Then, individuals' motor imagery abilities will be evaluated using HIA-3, mental rotation and mental stopwatch. After the evaluation, the individuals will be taken to a quiet and isolated room and the Polar H10 device will be placed on the chest area of the individuals to measure heart rate variations and (MP36 system and BİOPAC software) will be placed to measure the electrodermal activities of the individuals. Then, a motor imagery session will be held for individuals with a physiotherapist who is an expert in the field. Receives: Other: Motor Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrodermal Activity
Electrodermal activity recording will be carried out in the Research Laboratory of Kütahya Health Sciences University Faculty of Medicine, Department of Physiology, at normal room temperature (20±2⁰C) in a dimly lit room isolated against external factors. EDA recordings will be taken bilaterally with the MP36 system. EDA recordings were made using two instruments placed on the distal phalanx surface of the 2nd and 3rd fingers of both hands, two on the right hand and two on the left. It will be done with four Ag/AgCl electrodes in hand. These four electrodes will be connected to the MP 36 system.
Measured: 10 minutes
Polar HRV (Heart Rate Variability)
The Polar H10 heart rate sensor will be used to evaluate heart rate and heart rate variability.
Polar H10 is a heart rate sensor placed under the chest with an elastic electrode strap. RR intervals will be recorded for 5 minutes with the smartphone application.
Measurements will be taken with the participant in a sitting position, without any clothing in the area where the device will be placed.
Measured: 10 minutes
Secondary outcomes (3)
Mental Chronometer
The mental chronometer provides information about the temporal connection between real and simulated movements. As part of this evaluation, participants will be administered the Nine-Hole Peg Test.After practice, mental stopwatch data will be calculated as follows: (imaginary realization time - actual realization time).
Measured: 5 minutes
Mental Rotation
Mental rotation provides information about the accuracy of imagined movements. Mental rotation will be evaluated as a hand lateralization task, which is choosing which side the hand belongs to.
The test will be administered using the Recognize App Recognize Hand software developed and designed by the NOI group (Neuro Orthopedic Institute, Adelaide, Australia) (http://www.noigroup.com/Recognize).
Measured: 100 second
Kinesthetic and Visual Imagery Questionnaire
It was developed by Malouin et al. in 2007. The Turkish validity and reliability of the questionnaire was determined by Dilek et al. Made by.
KGIA; It is a questionnaire that consists of movements performed while seated, cannot be self-administered, consists of kinesthetic and visual imagery subsections, and measures how much individuals can visualize and feel the movement.
KGIA-10 is a 10-item version consisting of 5 movements, and each item is the same as 1 to 5.
It is scored between . It includes the movements mentioned in the 3rd, 5th, 6th, 8th and 9th articles of KGIA-20.
The total score of the survey varies between 10-50. Kinesthetic and visual imagery subscores range from 5 to 25.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start29 Apr 2024
- Primary completion8 Aug 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meltem Işıntaş, Study director, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482528
- Sponsor's protocol ID
- 2024/05-08
- Status last verified
- Apr 2024
- First submitted
- 26 Jun 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesthetic Motor Imagery on Heart Rate, Heart Rate Variability, and Skin Resistance
- ClinicalTrials.gov ID
- NCT06482528
- Acronym / sponsor ID
- 2024/05-08
- Conditions
- Healthy Individuals
- Keywords
- Imagery, autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 1 Jul 2024 (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.
Motor Imagery (MI) is defined as imagining an action in the mind without any explicit physical movement. MI is considered an "offline" process of the motor areas of the brain. Neuroimaging studies have shown that roughly the same neural structures play a role both during movement execution and MI. Specifically, these neural structures; supplementary motor area (SMA), premotor cortex (PMC), and in a growing number of studies, primary motor cortex (M1), inferior parietal lobe (IPL), basal ganglia, and cerebellum. In MI, the changes occurring in the Central Nervous System (CNS), such as the activation of the structures responsible for planning the movement and the purpose for which the movement will be performed, are similar to physical movement, but with the inhibition of the last motor neuron (primary motor area) responsible for revealing the movement, the movement is not physically performed and the motor visualization occurs.
During motor imagery, monitoring the quality of the individual's imagery session is very important for the effectiveness of the session. Additionally, studies have shown that giving the subject biofeedback regarding mental work can modulate the individual's mental work. For these purposes, the quality of an individual's motor imagery during a motor imagery session can be measured by biological measurement methods such as fMRI and autonomic nervous system response. In studies conducted on the autonomic nervous system response, changes in skin resistance and heart rate variations were observed. However, these methods are very costly and cannot be accessed in every clinic. In the literature, the Polar HRV device for measuring heart rate variability is a measuring device with proven validity and reliability and is easily accessible in terms of cost. However, we do not yet know whether Polar HRV is a valid and reliable measurement tool to measure the quality of an individual's imagery session during a motor imagery session.
This study aims to determine the effects of the individual's autonomic nervous system during the kinesthetic motor imagery session. To measure the responses and to investigate whether the polar HRV device is a valid and reliable tool.
Detailed description
Motor Imagery (MI) is imagining an action in the mind without any explicit physical movement. MI is considered an "offline" process of the motor areas of the brain. Neuroimaging studies have shown that roughly the same neural structures play a role both during movement execution and MI. Specifically, these neural structures; supplementary motor area (SMA), premotor cortex (PMC), and in a growing number of studies, primary motor cortex (M1), inferior parietal lobe (IPL), basal ganglia, and cerebellum. In MI, the changes occurring in the Central Nervous System (CNS), such as the activation of the structures responsible for planning the movement and the purpose for which the movement will be performed, are similar to physical movement, but with the inhibition of the last motor neuron (primary motor area) responsible for revealing the movement, the movement is not physically performed and the motor visualization occurs.
During motor imagery, monitoring the quality of the individual's imagery session is very important for the session's effectiveness. Additionally, studies have shown that giving the subject biofeedback regarding mental work can modulate the individual's mental work. For these purposes, the quality of an individual's motor imagery during a motor imagery session can be measured by biological measurement methods such as fMRI and autonomic nervous system response. In studies conducted on the autonomic nervous system response, changes in skin resistance and heart rate variations were observed. However, these methods are very costly and cannot be accessed in every clinic. In the literature, the Polar HRV device for measuring heart rate variability is a measuring device with proven validity and reliability and is easily accessible in terms of cost. However, we do not yet know whether Polar HRV is a valid and reliable measurement tool to measure the quality of an individual's imagery session during a motor imagery session.
This study aims to determine the effects of the individual's autonomic nervous system during the kinesthetic motor imagery session. To measure the responses and to investigate whether the polar HRV device is a valid and reliable tool.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motor imagery group | Experimental | Other: Motor ImageryIndividuals who meet the inclusion criteria will fill out the demographic data form after signing the informed consent form. Then, individuals' motor imagery abilities will be evaluated using HIA-3, mental rotation and mental stopwatch. After the evaluation, the individuals will be taken to a quiet and isolated room and the Polar H10 device will be placed on the chest area of the individuals to measure heart rate variations and (MP36 system and BİOPAC software) will be placed to measure the electrodermal activities of the individuals. Then, a motor imagery session will be held for individuals with a physiotherapist who is an expert in the field. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being 18-30 years old
- Volunteering to participate in the study
- Being seemingly healthy
- Not having any neurological or orthopedic disease
- Not having any vision, hearing, or speech problems that would prevent the tests from being performed.
Key exclusion criteria (3 listed)
- Pregnancy and a history of any previous disorder or surgery that alters physical performance or physiological functions
- Have previous experience with Motor Imagery techniques or training
- People being treated with any medication that affects the central nervous system will not be included in the study.
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 |
|---|---|---|
| Motor ImageryAlso: RelaxationAfter the measurement devices are connected to the individuals, they will be seated in a comfortable chair. After the calibration of the devices, individuals will undergo a 2-minute relaxation session. During the relaxation session, individuals will be asked to focus on their breathing and relax as much as possible. Then, heart rate variability, electrodermal activities and respiratory frequencies of the individuals will be measured in a sitting position for 5 minutes. In case of rest, after taking the variables, individuals will be kept to rest for 10 minutes. After 10 minutes, the devices will be placed on the individuals again and a 2-minute relaxation session will be held. Then, individuals will be asked to imagine running through kinesthetic imagery for 5 minutes. Feedback will be given to individuals throughout the entire session. These feedbacks will be given verbally with an audio recording prepared by the physiotherapist. | Other | Motor imagery group |
Primary outcome
Electrodermal Activity
Time frame: 10 minutes
Electrodermal activity recording will be carried out in the Research Laboratory of Kütahya Health Sciences University Faculty of Medicine, Department of Physiology, at normal room temperature (20±2⁰C) in a dimly lit room isolated against external factors. EDA recordings will be taken bilaterally with the MP36 system. EDA recordings were made using two instruments placed on the distal phalanx surface of the 2nd and 3rd fingers of both hands, two on the right hand and two on the left. It will be done with four Ag/AgCl electrodes in hand. These four electrodes will be connected to the MP 36 system.
Polar HRV (Heart Rate Variability)
Time frame: 10 minutes
The Polar H10 heart rate sensor will be used to evaluate heart rate and heart rate variability. Polar H10 is a heart rate sensor placed under the chest with an elastic electrode strap. RR intervals will be recorded for 5 minutes with the smartphone application. Measurements will be taken with the participant in a sitting position, without any clothing in the area where the device will be placed.
3 secondary outcomes
Mental Chronometer
Time frame: 5 minutes
Mental Rotation
Time frame: 100 second
Kinesthetic and Visual Imagery Questionnaire
Time frame: 15 minutes
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 5 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Meltem Işıntaş study director
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery in people with Healthy Individuals, run by Kutahya Health Sciences University 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 5 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 5 Mar 2025. 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?
Electrodermal Activity (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 5 Mar 2025.