HealthyNCT05219682
Changes in Brain Activity During Mirror Therapy and Virtual Reality Therapy
A study testing electroencephalographic measurement in people with Healthy and Age of Probands 18 - 55 Years, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The purpose of this study is to compare electroencephalographic activity in upper limb rehabilitation with mirror therapy and virtual reality rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Age of Probands 18 - 55 Years
- What is being tested?
- electroencephalographic measurement
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2021to 1 Apr 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a healthy individual with a valid medical examination.
Who cannot join
- Having a stroke or other illness that is related to a disorder of movement of the upper limbs. Severe visual or auditory deficit and decompensated epilepsy due to screen movement tracking. Persons with acute (especially infectious) diseases did not participate in the research.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Faculty of Physical Education and Sport at Charles University
Prague, 162 52
About this study
Official title: Changes in Brain Activity in Tactile Stimulus Therapy and Ruka Ruk Therapy Compared to Mirror Therapy in Upper Limb Rehabilitation.
The purpose of this study is to compare electroencephalographic activity in upper limb rehabilitation with mirror therapy and virtual reality rehabilitation.
Read the detailed description
This is an experiment measuring EEG to healthy adult probands during mirror therapy and VR mirroring therapy in the upper limb. The experiment will be supplemented by haptic contact and stimulation of the upper limb with a foam roller. According to the instructions, the participants will perform a predetermined movement with one upper limb - clenching the fist. In one part with the mirror, in the other part the sensor for sensing the movement of the hand detects the movement, the software creates the illusion that the patient performs the same movement with the dominant and non-dominant upper limb. The patient sees on the screen the illusion of movement of both of his upper limbs. During therapy, the other upper limb will be tactively stimulated haptically and with a foam roller. Data collection will take place by measuring the electrical activity of the brain using an EEG device. The obtained data will then be processed and evaluated with the help of the sLORETA program. The aim of this work is to compare the brain activity from the above therapies with the resting state of the proband and to focus on the activity of mirror neurons.
- Conditions
- Healthy, Age of Probands 18 - 55 Years
- Being tested
- electroencephalographic measurement
- Keywords
- EEG, Virtual Reality, Rehabilitation, Mirror neurons, Mirror Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalographic measurementOther
Also called Haptic stimulation, tactile foam roller stimulation, mirror therapy, Virtual reality
recording brain activity in mirror therapy, haptic and tactile stimulation and in mirror therapy using virtual reality
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of EEG for each intervention versus the resting phase of the measurement
After processing the data in the sLORETA program, statistically significant places with different brain activity during interventions were identified, each type of intervention is evaluated separately.
Measured: month
Secondary outcomes (1)
Comparison of electroencephalographic recordings from mirror therapy with therapy in virtual reality
After processing the data in the sLORETA program, statistically significant places with different brain activity during interventions were identified, each type of intervention is evaluated separately.
Measured: month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Sep 2021
- Primary completion11 Nov 2021
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant started with EEG measurements at rest followed by 3 EEG measurements in mirror therapy and 3 EEG measurements with mirror therapy in virtual reality. The order of measurement was randomized.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kateřina Pilátová, Charles University, Czech Republic
- Investigators
- MUDr. David Pánek, Ph.D., Study director, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219682
- Sponsor's protocol ID
- 200/2020
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2022
- Last updated
- 2 Feb 2022
- 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 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Brain Activity in Tactile Stimulus Therapy and Ruka Ruk Therapy Compared to Mirror Therapy in Upper Limb Rehabilitation.
- ClinicalTrials.gov ID
- NCT05219682
- Acronym / sponsor ID
- 200/2020
- Conditions
- Healthy, Age of Probands 18 - 55 Years
- Keywords
- EEG, Virtual Reality, Rehabilitation, Mirror neurons, Mirror Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 2 Feb 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.
The purpose of this study is to compare electroencephalographic activity in upper limb rehabilitation with mirror therapy and virtual reality rehabilitation.
Detailed description
This is an experiment measuring EEG to healthy adult probands during mirror therapy and VR mirroring therapy in the upper limb. The experiment will be supplemented by haptic contact and stimulation of the upper limb with a foam roller. According to the instructions, the participants will perform a predetermined movement with one upper limb - clenching the fist. In one part with the mirror, in the other part the sensor for sensing the movement of the hand detects the movement, the software creates the illusion that the patient performs the same movement with the dominant and non-dominant upper limb. The patient sees on the screen the illusion of movement of both of his upper limbs. During therapy, the other upper limb will be tactively stimulated haptically and with a foam roller. Data collection will take place by measuring the electrical activity of the brain using an EEG device. The obtained data will then be processed and evaluated with the help of the sLORETA program. The aim of this work is to compare the brain activity from the above therapies with the resting state of the proband and to focus on the activity of mirror neurons.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Each participant started with EEG measurements at rest followed by 3 EEG measurements in mirror therapy and 3 EEG measurements with mirror therapy in virtual reality. The order of measurement was randomized.
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- a healthy individual with a valid medical examination.
Key exclusion criteria (1 listed)
- Having a stroke or other illness that is related to a disorder of movement of the upper limbs. Severe visual or auditory deficit and decompensated epilepsy due to screen movement tracking. Persons with acute (especially infectious) diseases did not participate in the research.
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 |
|---|---|---|
| electroencephalographic measurementAlso: Haptic stimulation, tactile foam roller stimulation, mirror therapy, Virtual realityrecording brain activity in mirror therapy, haptic and tactile stimulation and in mirror therapy using virtual reality | Other | – |
Primary outcome
Comparison of EEG for each intervention versus the resting phase of the measurement
Time frame: month
After processing the data in the sLORETA program, statistically significant places with different brain activity during interventions were identified, each type of intervention is evaluated separately.
1 secondary outcome
Comparison of electroencephalographic recordings from mirror therapy with therapy in virtual reality
Time frame: month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- 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.
MUDr. David Pánek, Ph.D. study director
Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalographic measurement in people with Healthy and Age of Probands 18 - 55 Years, run by Charles University, Czech Republic at 1 site in Czechia.
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 2 Feb 2022. 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 Czechia. 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?
Results are not available in the source record.
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?
Comparison of EEG for each intervention versus the resting phase of the measurement (time frame: month). 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 2 Feb 2022.