Body ImageNCT05339776
Hand Lateralization by Using EEG Analysis Method in Amputees
A study testing Hand Lateralization Test in people with Body Image, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Studies on the improvement of body image or body perception have proven their effectiveness in different clinical situations such as pain management and chronic pain treatment. The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Body Image
- What is being tested?
- Hand Lateralization Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 27 Mar 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being between ages 18-65,
- consenting,
- with no limitation in mobility or movement disorder,
- A score of 21 or higher on the Montreal Cognitive Assessment Test
- between ages 18-65,
- using prosthesis,
- A score of 21 or higher on the Montreal Cognitive Assessment Test
Who cannot join
- refuse to attend to the study,
- Having any mental, neurological or musculoskeletal problems,
- Inability to perform activities that require long-term attention,
- Inability to detect given commands,
- Using sedative drugs and/or derivatives
- Amputee group:
Show all 13Show fewer
- Having phantom pain,
- Having open wound on stump,
- Having any discomfort feeling on stump,
- Having any mental, neurological or musculoskeletal problems,
- Inability to perform activities that require long-term attention,
- Inability to detect given commands,
- Using sedative drugs and/or derivatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hand Lateralization Cognitive Task From Different Personal Perspectives by Using EEG Analysis Method in Amputees
Studies on the improvement of body image or body perception have proven their effectiveness in different clinical situations such as pain management and chronic pain treatment. The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees. In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants. Data will be recorded via EEG and Eprime software program.
Read the detailed description
The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees.
In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants.
It was planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Control group will be matched in terms of age and gender with the amputees group. Before hand lateralization test, participants will be evaluated regarding eligible criterias and EEG paradigm regarding hand lateralization will be performed for each participant.
Both groups (Amputees and Control) will complete "hand lateralization program" for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system.
Following 10-day period, EEG paradigm regarding hand lateralization will be performed for each participant, again.
Before and after comparisons will be analyzed. Data will be recorded via EEG and Eprime software program.
EEG-Event Related Oscillation (power spectrum, phase locking) analysis will be performed for each frequency bands: alpha, theta, beta, gamma.
Eprime analysis will be performed for the data of reaction time and accuracy rate.
- Conditions
- Body Image
- Being tested
- Hand Lateralization Test
- Keywords
- EEG, mental rotation, hand lateralization, hand recognition, amputees, body schema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Lateralization TestBehavioural
Before hand lateralization test, participants will be evaluated. Both groups (Amputees and Control) will complete hand lateralization test for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system. After hand lateralization test, participants will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| One of groups: amputees group | Active comparator | We planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Both groups will enroll "hand lateralization" for at least 10 days. Before and after comparisons will be analyzed. Receives: Behavioral: Hand Lateralization Test |
| One of groups: control group | Active comparator | Control group will be matched in terms of age and gender with the amputees group. Receives: Behavioral: Hand Lateralization Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma
Changes in power spectrum and phase locking
Measured: Before and after the hand lateralization test: 10-14 days
Secondary outcomes (2)
Reaction time to decide whether the hand is right or left
E-prime parameter: recorded as milisecond
Measured: Before and after the hand lateralization test: 10-14 days
Accuracy proportion of given answers regarding hand lateralization
E-prime parameter: recorded as percentage
Measured: Before and after the hand lateralization test: 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Mar 2021
- Primary completion26 Aug 2022
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body ImageStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Burcu Dilek, Trakya University
- Investigators
- Burcu Dilek, PhD, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339776
- Sponsor's protocol ID
- E-10840098-772.02-6568
- Status last verified
- Sep 2023
- First submitted
- 1 Apr 2022
- Last updated
- 21 Sep 2023
- Results posted
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hand Lateralization Cognitive Task From Different Personal Perspectives by Using EEG Analysis Method in Amputees
- ClinicalTrials.gov ID
- NCT05339776
- Acronym / sponsor ID
- E-10840098-772.02-6568
- Conditions
- Body Image
- Keywords
- EEG, mental rotation, hand lateralization, hand recognition, amputees, body schema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 21 Apr 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.
Studies on the improvement of body image or body perception have proven their effectiveness in different clinical situations such as pain management and chronic pain treatment. The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees. In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants. Data will be recorded via EEG and Eprime software program.
Detailed description
The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees.
In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants.
It was planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Control group will be matched in terms of age and gender with the amputees group. Before hand lateralization test, participants will be evaluated regarding eligible criterias and EEG paradigm regarding hand lateralization will be performed for each participant.
Both groups (Amputees and Control) will complete "hand lateralization program" for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system.
Following 10-day period, EEG paradigm regarding hand lateralization will be performed for each participant, again.
Before and after comparisons will be analyzed. Data will be recorded via EEG and Eprime software program.
EEG-Event Related Oscillation (power spectrum, phase locking) analysis will be performed for each frequency bands: alpha, theta, beta, gamma.
Eprime analysis will be performed for the data of reaction time and accuracy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One of groups: amputees group | Active comparator | Behavioral: Hand Lateralization TestWe planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Both groups will enroll "hand lateralization" for at least 10 days. Before and after comparisons will be analyzed. |
| One of groups: control group | Active comparator | Behavioral: Hand Lateralization TestControl group will be matched in terms of age and gender with the amputees group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- being between ages 18-65,
- consenting,
- with no limitation in mobility or movement disorder,
- A score of 21 or higher on the Montreal Cognitive Assessment Test
- between ages 18-65,
Key exclusion criteria (13 listed)
- refuse to attend to the study,
- Having any mental, neurological or musculoskeletal problems,
- Inability to perform activities that require long-term attention,
- Inability to detect given commands,
- Using sedative drugs and/or derivatives
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 |
|---|---|---|
| Hand Lateralization TestBefore hand lateralization test, participants will be evaluated. Both groups (Amputees and Control) will complete hand lateralization test for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system. After hand lateralization test, participants will be evaluated. | Behavioural | One of groups: amputees group, One of groups: control group |
Primary outcome
Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma
Time frame: Before and after the hand lateralization test: 10-14 days
Changes in power spectrum and phase locking
2 secondary outcomes
Reaction time to decide whether the hand is right or left
Time frame: Before and after the hand lateralization test: 10-14 days
Accuracy proportion of given answers regarding hand lateralization
Time frame: Before and after the hand lateralization test: 10-14 days
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 21 Sep 2023.
- 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.
Burcu Dilek, PhD principal investigator
Trakya 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 Hand Lateralization Test in people with Body Image, run by Trakya 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 7 inclusion and 13 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 21 Sep 2023. 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?
Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma (time frame: Before and after the hand lateralization test: 10-14 days). 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 21 Sep 2023.