Motor Imagery TrainingNCT04171271
Effects of Motor Imagery on Autonomic Function
A study testing Activating kinesthetic motor imagery training and Relaxing kinesthetic motor imagery training in people with Motor Imagery Training, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Most studies on motor imagery suggested the effects of motor imagery are related to neuroplastic changes in the brain. In addition to that the neuroplastic changes, it is thought that motor imagery can alter metabolic responses just like in actual exercise. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Imagery Training
- What is being tested?
- Activating kinesthetic motor imagery training and Relaxing kinesthetic motor imagery training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2019to 31 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being healthy (not having any known chronic disease)
- Volunteer to participate in the study
Who cannot join
- Pregnancy
- Previous disorder/surgery history that can alter physical performance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Motor Imagery on Autonomic Function and Motor Imagery Abilities in Healthy Individuals
Most studies on motor imagery suggested the effects of motor imagery are related to neuroplastic changes in the brain. In addition to that the neuroplastic changes, it is thought that motor imagery can alter metabolic responses just like in actual exercise. However, the level of evidence about the effect of motor imagery on autonomic functions is limited.
The aims of this study;
Read more
- The primary aim of this study is to investigate the effects of activating and relaxing kinesthetic motor imagery on autonomic function in healthy individuals and to compare these two methods.
- The secondary aim of this study is to explore the effects of these methods on motor imagery skills of individuals will also be investigated.
The participants will randomly be allocated into three groups: (1) Activating kinesthetic motor imagery training, (2) Relaxing kinesthetic motor imagery training, and (3) Control group.
Participants in the activating kinesthetic motor imagery training group will imagine high effort exercises (e.g. planking, boxing, jumping, squats, push-ups) in the sessions in home using the study audio-video motor imagery script. The relaxing kinesthetic motor imagery training group will imagine relaxing (low effort) exercises (e.g. breathing exercises, stretching, body awareness exercises) in home using the study audio-video motor imagery script. Prior the sessions, the participants will receive an introductory lecture about motor imagery. The intervention groups will practise 5 times per week for 17 minutes per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week). The control group will receive no specific training. Data will be collected at baseline and after the two-week intervention by masked outcome assessors.
- Conditions
- Motor Imagery Training
- Being tested
- Activating kinesthetic motor imagery training, Relaxing kinesthetic motor imagery training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activating kinesthetic motor imagery trainingBehavioural
Participants in the activating kinesthetic motor imagery training group will imagine high effort exercises (e.g. planking, boxing, jumping, squats, push-ups) in the sessions in home using the study audio-video motor imagery script for 5 times per week; 17 min per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week).
Relaxing kinesthetic motor imagery trainingBehavioural
Participants in the relaxing kinesthetic motor imagery training group will imagine relaxing (low effort) exercises (e.g. breathing exercises, stretching, body awareness exercises) in home using the study audio-video motor imagery script 5 times per week; 17 min per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week).
| Study group | Role | What they receive |
|---|---|---|
| Activating kinesthetic motor imagery training | Experimental | Not described Receives: Behavioral: Activating kinesthetic motor imagery training |
| Relaxing kinesthetic motor imagery training | Active comparator | Not described Receives: Behavioral: Relaxing kinesthetic motor imagery training |
| Control (no specific intervention) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the methods - minimum recruitment rate
A minimum recruitment rate of 10 participants per month will be accepted as feasiable.
Measured: through Study Completion, an Average of 8 Months
Feasibility of the methods - minimum retention rate
A target retention rate of 80% will be accepted as feasiable.
Measured: through Study Completion, an Average of 8 Months
Feasibility of the methods - minimum adherence rate
A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasiable.
Measured: through Study Completion, an Average of 8 Months
Feasibility of the methods - adverse events
A record sheet was prepared for possible adverse events during the tests and intervention. It includes information about seriousness, expectedness, severity, causality, time, duration of the event and clinical action taken. The numbers of adverse events will be reported.
Measured: through Study Completion, an Average of 8 Months
Secondary outcomes (7)
Edinburgh Handedness Inventory
The Edinburgh Handedness Inventory is a measurement scale used to assess the dominance of a person's right or left hand in everyday activities, sometimes referred to as laterality. The 10-item inventory contains a list of instructions to be carried out by the individual being assessed. Items are rated by direct observation of the individual's behavior or by self-report of everyday behavior. Scoring is as follows: "-50" always left, "-25" usually left, "0" no preference, "25" usually right, and "50" always right. Scores on the eight rows are summed to provide a score of -400 to +400. Positive scores indicate right-hand dominance and negative scores indicate left-hand dominance.
Measured: at Baseline
Movement Imagery Questionnaire-Revised
The Movement Imagery Questionnaire-Revised assesses visual and kinesthetic movement imagery ability and is comprised of four visual and four kinesthetic items. Each item entails performing a movement, visually or kinesthetically imaging that movement and then rating the ease or difficulty of generating that image on a 7-point scale from 1 = very hard to see/feel to 7 = very easy to see/feel. Higher scores indicate higher visual or kinesthetic movement imagery ability.
Measured: Change from Baseline at 2 Weeks
Mental chronometry for walking task
The participants will actually execute and imagine a motor task: walking at comfortable speed for a distance of 6 m. The duration of actual and imagined movements will be recorded by means of an electronic stopwatch. During the execution of the actual and imagined movements subjects will hold the electronic stopwatch in their non-dominant hand. They will start the stopwatch when they started to move (actual or imagined movement) and they will stop it when they completed their movement (actual or imagined). Delta time will be calculated with the formula [(actual - imagined) / (actual + imagined / 2)] × 100. Lower scores indicate higher motor imagery ability.
Measured: Change from Baseline at 2 Weeks
Mental chronometry for writing task
The participants will actually execute and imagine a motor task: writing the following sentence: "Türkiye'nin başkenti Ankara". The duration of actual and imagined movements will be recorded by means of an electronic stopwatch. During the execution of the actual and imagined movements subjects will hold the electronic stopwatch in their non-dominant hand. They will start the stopwatch when they started to move (actual or imagined movement) and they will stop it when they completed their movement (actual or imagined). Delta time will be calculated with the formula [(actual - imagined) / (actual + imagined / 2)] × 100. Lower scores indicate higher motor imagery ability.
Measured: Change from Baseline at 2 Weeks
Hand Laterality Judgement Measurement
A tablet including an application Recognise™ app, NOI) will be placed on a table while the participants sitting in a standard chair. When given the cue to begin, participants will view the image and touch the screen to select the appropriate hand laterality judgement image interpretation. A standard 5-s maximum time limit per image will be set on the app. At the completion of the 40 images the accuracy for right, left, and total will be recorded along with average time per image to the nearest hundredth of a second.
Measured: Change from Baseline at 2 Weeks
Resting Metabolic Rate Measurements - Oxygen Consumption
Quark cardiopulmonary exercise testing system will be used to assess Resting Metabolic Rate Measurements. Oxygen consumption is an indicator of aerobic capacity. Higher scores indicate higher aerobic capacity.
Measured: Change from Baseline at 2 Weeks
Resting Metabolic Rate Measurements - Respiratory Exchange Ratio
Quark cardiopulmonary exercise testing system will be used to assess Resting Metabolic Rate Measurements. The ratio of carbon dioxide output/oxygen uptake is called the respiratory exchange ratio. Under steady state conditions, the respiratory exchange ratio equals the respiratory quotient. The respiratory quotient value is determined by the fuels used for metabolic processes. An respiratory quotient of 1 indicates metabolism primarily of carbohydrates, whereas an respiratory quotient of <1 indicates a mixture of carbohydrates and fat (respiratory quotient about 0.7) or protein (respiratory quotient about 0.8).
Measured: Change from Baseline at 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start21 Nov 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Imagery TrainingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turhan Kahraman, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171271
- Sponsor's protocol ID
- 2019-GOKAE-1150
- Status last verified
- Feb 2021
- First submitted
- 18 Nov 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery on Autonomic Function and Motor Imagery Abilities in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04171271
- Acronym / sponsor ID
- 2019-GOKAE-1150
- Conditions
- Motor Imagery Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 20 Nov 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.
Most studies on motor imagery suggested the effects of motor imagery are related to neuroplastic changes in the brain. In addition to that the neuroplastic changes, it is thought that motor imagery can alter metabolic responses just like in actual exercise. However, the level of evidence about the effect of motor imagery on autonomic functions is limited.
The aims of this study;
- The primary aim of this study is to investigate the effects of activating and relaxing kinesthetic motor imagery on autonomic function in healthy individuals and to compare these two methods.
- The secondary aim of this study is to explore the effects of these methods on motor imagery skills of individuals will also be investigated.
The participants will randomly be allocated into three groups: (1) Activating kinesthetic motor imagery training, (2) Relaxing kinesthetic motor imagery training, and (3) Control group.
Participants in the activating kinesthetic motor imagery training group will imagine high effort exercises (e.g. planking, boxing, jumping, squats, push-ups) in the sessions in home using the study audio-video motor imagery script. The relaxing kinesthetic motor imagery training group will imagine relaxing (low effort) exercises (e.g. breathing exercises, stretching, body awareness exercises) in home using the study audio-video motor imagery script. Prior the sessions, the participants will receive an introductory lecture about motor imagery. The intervention groups will practise 5 times per week for 17 minutes per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week). The control group will receive no specific training. Data will be collected at baseline and after the two-week intervention by masked outcome assessors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Activating kinesthetic motor imagery training | Experimental | Behavioral: Activating kinesthetic motor imagery training |
| Relaxing kinesthetic motor imagery training | Active comparator | Behavioral: Relaxing kinesthetic motor imagery training |
| Control (no specific intervention) | No intervention | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being healthy (not having any known chronic disease)
- Volunteer to participate in the study
Key exclusion criteria (2 listed)
- Pregnancy
- Previous disorder/surgery history that can alter physical performance
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 |
|---|---|---|
| Activating kinesthetic motor imagery trainingParticipants in the activating kinesthetic motor imagery training group will imagine high effort exercises (e.g. planking, boxing, jumping, squats, push-ups) in the sessions in home using the study audio-video motor imagery script for 5 times per week; 17 min per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week). | Behavioural | Activating kinesthetic motor imagery training |
| Relaxing kinesthetic motor imagery trainingParticipants in the relaxing kinesthetic motor imagery training group will imagine relaxing (low effort) exercises (e.g. breathing exercises, stretching, body awareness exercises) in home using the study audio-video motor imagery script 5 times per week; 17 min per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week). | Behavioural | Relaxing kinesthetic motor imagery training |
Primary outcome
Feasibility of the methods - minimum recruitment rate
Time frame: through Study Completion, an Average of 8 Months
A minimum recruitment rate of 10 participants per month will be accepted as feasiable.
Feasibility of the methods - minimum retention rate
Time frame: through Study Completion, an Average of 8 Months
A target retention rate of 80% will be accepted as feasiable.
Feasibility of the methods - minimum adherence rate
Time frame: through Study Completion, an Average of 8 Months
A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasiable.
Feasibility of the methods - adverse events
Time frame: through Study Completion, an Average of 8 Months
A record sheet was prepared for possible adverse events during the tests and intervention. It includes information about seriousness, expectedness, severity, causality, time, duration of the event and clinical action taken. The numbers of adverse events will be reported.
7 secondary outcomes
Edinburgh Handedness Inventory
Time frame: at Baseline
Movement Imagery Questionnaire-Revised
Time frame: Change from Baseline at 2 Weeks
Mental chronometry for walking task
Time frame: Change from Baseline at 2 Weeks
Mental chronometry for writing task
Time frame: Change from Baseline at 2 Weeks
Hand Laterality Judgement Measurement
Time frame: Change from Baseline at 2 Weeks
Resting Metabolic Rate Measurements - Oxygen Consumption
Time frame: Change from Baseline at 2 Weeks
Resting Metabolic Rate Measurements - Respiratory Exchange Ratio
Time frame: Change from Baseline at 2 Weeks
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 17 Feb 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activating kinesthetic motor imagery training and Relaxing kinesthetic motor imagery training in people with Motor Imagery Training, run by Izmir Katip Celebi 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 2 inclusion and 2 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 17 Feb 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?
Feasibility of the methods - minimum recruitment rate (time frame: through Study Completion, an Average of 8 Months). The study lists 4 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 17 Feb 2021.