EpilepsyNCT06376370
The Effect of a Computer-Assisted Rehabilitation Program on Epilepsy Patient
A study testing Application of computer-assisted cognitive rehabilitation program in people with Epilepsy and Computer-assisted Cognitive Rehabilitation, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of the RehaCom Computer-Assisted Rehabilitation Program Applied to Epilepsy Patients on Self-Management, Cognitive Function and Quality of Life. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Computer-assisted Cognitive Rehabilitation, Quality of Life
- What is being tested?
- Application of computer-assisted cognitive rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2024to 28 Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being registered at Selçuk University Faculty of Medicine Hospital Neurology Polyclinic
- Having been diagnosed with epilepsy for at least 6 months
- Being between the ages of 18 and 60 (60 is the age limit for the Moxo test)
- Volunteer to provide transportation to Selçuk University Faculty of Medicine for research one day a week.
- Ability to use tools such as computer mouse and telephone
- Score 24 or more from the Mini Mental State Test
Who cannot join
- Individuals have physical, mental, visual and hearing disabilities
- Having another neurological disorder
- The individual has a transportation disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of RehaCom Computer-Assisted Rehabilitation Program on Self-Management, Cognitive Function and Quality of Life in Epilepsy Patients: Randomized Controlled Study
The aim of this study is to examine the effects of the RehaCom Computer-Assisted Rehabilitation Program Applied to Epilepsy Patients on Self-Management, Cognitive Function and Quality of Life.
Read the detailed description
Modules designed to train cognitive abilities will be used under the supervision of a licensed researcher who is licensed to use the RehaCom application, which is a computer-assisted cognitive rehabilitation program. Researchers can select some modules based on each patient's specific deficits, meaning that deficits can be targeted and specifically trained. Since the program will respond to the patient's specific needs, the activity may become easier or more difficult depending on the patient's performance. Epilepsy patients will be encouraged by researchers during the exercises and will be able to give feedback on progress at the end of the session. After determining the appropriate time and day for each patient in the experimental group, the intervention will continue for 6 weeks with 45-minute sessions once a week.
- Being tested
- Application of computer-assisted cognitive rehabilitation program
- Keywords
- Epilepsy patient, Cognitive rehabilitation, Self management
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of computer-assisted cognitive rehabilitation programOther
Since the program will respond to the patient's specific needs, the activity may become easier or more difficult depending on the patient's performance. Epilepsy patients will be encouraged by researchers during the exercises and will be able to give feedback on progress at the end of the session. After determining the appropriate time and day for each patient in the experimental group, the intervention will continue for 6 weeks with 45-minute sessions once a week.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Patients with epilepsy who will receive a computer-assisted cognitive rehabilitation program Receives: Other: Application of computer-assisted cognitive rehabilitation program |
| Control | No intervention | Patients under routine follow-up of the clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Test
Mini-mental state test (MMSE), a simple screening test, is a useful test that indicates cognitive impairment and is also used in follow-up.The mini mental state assessment test developed by Folstein et al. (1975) is a test that measures patients' orientation, memory, attention and calculation, recall, language, motor function and perception aspects and is evaluated out of 30 points. It is accepted that cognitive status worsens as the scores patients receive decrease. Although the test has limited specificity in terms of distinguishing clinical syndromes, it is a short, useful and standardized method that can be used to determine the cognitive level globally.
Measured: 5 minutes
Epilepsy Quality of Life Scale
The validity and reliability study of the E-31 Scale and the QOLIE-89 Scale in our country was conducted by Mollaoğlu et al. It is a scale consisting of 31 items out of 89 items in the QOLIE-89 Scale made by. In the QOLIE-31 Scale, only epilepsy-related issues are questioned. QOLIE -31 scale consists of 7 sub-dimensions including the following health concepts. These sub-dimensions; seizure-related concerns (5 items), emotional well-being (5 items), energy/fatigue (4 items), social function (5 items), cognitive function (6 items), effects of medications (3 items), total quality of life (2 items). It consists of a total of 31 items, including an additional item assessing total health status. The QOLIE-31 Scale, which normally consists of 30 items, has gained the feature of a 31-item scale with the addition of this last item (the item that evaluates the total health status). The scale is scored between 0-100. A high score reflects a high quality of life.
Measured: 10 minutes
MOXO Test
MOXO Adult is a computerized, distractor-continuous performance test, an objective tool that measures a person's attention profile. The MOXO Adult test includes distractor systems that establish a connection with the person's environment. MOXO continuous performance test is a measurement tool designed to diagnose symptoms related to attention and cognitive status, with scientifically proven sensitivity (90%) and specificity (85%). The test is an 18.2-minute test consisting of eight blocks (53 trials in each block). On each trial, a stimulus (target or nontarget) is presented in the center of the computer screen. This is followed by a "gap" of the same period in which no stimulus is presented. Participants are asked to press the space bar in response to targets and to refrain from pressing it in response to nontargets. This is done by ignoring a number of visual and auditory distractions.
Measured: 18 minutes
Epilepsy Self-Management Scale
The Epilepsy Self-Management Scale was developed by Dilorio et al. (2004) mainly to evaluate the frequency of use of epilepsy self-management practices or behaviors. The validity and reliability study of the scale was conducted by Yeni et al. (2020). This scale, consisting of 38 items, has five subsections that evaluate medication (10 items), information (8 items), safety (8 items), seizure (6 items) and lifestyle (6 items) management in epilepsy patients. Responses are evaluated in a 5-point Likert format and scored between 1-5. Scoring is done on a frequency scale, where 1 is "never" and 5 is "always". There are also reverse coded items in the scale, and these are converted to their normal form during the evaluation and included in the process. The minimum score that can be obtained from the scale is 38 and the maximum score is 190, and high scores indicate that patients have good self-management.
Measured: 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start26 Apr 2024 (estimated)
- Primary completion10 Jun 2024 (estimated)
- Study completion28 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Saygılı, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376370
- Sponsor's protocol ID
- 16.04.24/2
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of RehaCom Computer-Assisted Rehabilitation Program on Self-Management, Cognitive Function and Quality of Life in Epilepsy Patients: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06376370
- Acronym / sponsor ID
- 16.04.24/2
- Keywords
- Epilepsy patient, Cognitive rehabilitation, Self management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 26 Apr 2024 (estimated)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 28 Jul 2024 (estimated)
- First posted
- 19 Apr 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.
The aim of this study is to examine the effects of the RehaCom Computer-Assisted Rehabilitation Program Applied to Epilepsy Patients on Self-Management, Cognitive Function and Quality of Life.
Detailed description
Modules designed to train cognitive abilities will be used under the supervision of a licensed researcher who is licensed to use the RehaCom application, which is a computer-assisted cognitive rehabilitation program. Researchers can select some modules based on each patient's specific deficits, meaning that deficits can be targeted and specifically trained. Since the program will respond to the patient's specific needs, the activity may become easier or more difficult depending on the patient's performance. Epilepsy patients will be encouraged by researchers during the exercises and will be able to give feedback on progress at the end of the session. After determining the appropriate time and day for each patient in the experimental group, the intervention will continue for 6 weeks with 45-minute sessions once a week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Other: Application of computer-assisted cognitive rehabilitation programPatients with epilepsy who will receive a computer-assisted cognitive rehabilitation program |
| Control | No intervention | –Patients under routine follow-up of the clinic |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being registered at Selçuk University Faculty of Medicine Hospital Neurology Polyclinic
- Having been diagnosed with epilepsy for at least 6 months
- Being between the ages of 18 and 60 (60 is the age limit for the Moxo test)
- Volunteer to provide transportation to Selçuk University Faculty of Medicine for research one day a week.
- Ability to use tools such as computer mouse and telephone
Key exclusion criteria (3 listed)
- Individuals have physical, mental, visual and hearing disabilities
- Having another neurological disorder
- The individual has a transportation disability
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 |
|---|---|---|
| Application of computer-assisted cognitive rehabilitation programSince the program will respond to the patient's specific needs, the activity may become easier or more difficult depending on the patient's performance. Epilepsy patients will be encouraged by researchers during the exercises and will be able to give feedback on progress at the end of the session. After determining the appropriate time and day for each patient in the experimental group, the intervention will continue for 6 weeks with 45-minute sessions once a week. | Other | Study |
Primary outcome
Mini Mental State Test
Time frame: 5 minutes
Mini-mental state test (MMSE), a simple screening test, is a useful test that indicates cognitive impairment and is also used in follow-up.The mini mental state assessment test developed by Folstein et al. (1975) is a test that measures patients' orientation, memory, attention and calculation, recall, language, motor function and perception aspects and is evaluated out of 30 points. It is accepted that cognitive status worsens as the scores patients receive decrease. Although the test has limited specificity in terms of distinguishing clinical syndromes, it is a short, useful and standardized method that can be used to determine the cognitive level globally.
Epilepsy Quality of Life Scale
Time frame: 10 minutes
The validity and reliability study of the E-31 Scale and the QOLIE-89 Scale in our country was conducted by Mollaoğlu et al. It is a scale consisting of 31 items out of 89 items in the QOLIE-89 Scale made by. In the QOLIE-31 Scale, only epilepsy-related issues are questioned. QOLIE -31 scale consists of 7 sub-dimensions including the following health concepts. These sub-dimensions; seizure-related concerns (5 items), emotional well-being (5 items), energy/fatigue (4 items), social function (5 items), cognitive function (6 items), effects of medications (3 items), total quality of life (2 items). It consists of a total of 31 items, including an additional item assessing total health status. The QOLIE-31 Scale, which normally consists of 30 items, has gained the feature of a 31-item scale with the addition of this last item (the item that evaluates the total health status). The scale is scored between 0-100. A high score reflects a high quality of life.
MOXO Test
Time frame: 18 minutes
MOXO Adult is a computerized, distractor-continuous performance test, an objective tool that measures a person's attention profile. The MOXO Adult test includes distractor systems that establish a connection with the person's environment. MOXO continuous performance test is a measurement tool designed to diagnose symptoms related to attention and cognitive status, with scientifically proven sensitivity (90%) and specificity (85%). The test is an 18.2-minute test consisting of eight blocks (53 trials in each block). On each trial, a stimulus (target or nontarget) is presented in the center of the computer screen. This is followed by a "gap" of the same period in which no stimulus is presented. Participants are asked to press the space bar in response to targets and to refrain from pressing it in response to nontargets. This is done by ignoring a number of visual and auditory distractions.
Epilepsy Self-Management Scale
Time frame: 12 minutes
The Epilepsy Self-Management Scale was developed by Dilorio et al. (2004) mainly to evaluate the frequency of use of epilepsy self-management practices or behaviors. The validity and reliability study of the scale was conducted by Yeni et al. (2020). This scale, consisting of 38 items, has five subsections that evaluate medication (10 items), information (8 items), safety (8 items), seizure (6 items) and lifestyle (6 items) management in epilepsy patients. Responses are evaluated in a 5-point Likert format and scored between 1-5. Scoring is done on a frequency scale, where 1 is "never" and 5 is "always". There are also reverse coded items in the scale, and these are converted to their normal form during the evaluation and included in the process. The minimum score that can be obtained from the scale is 38 and the maximum score is 190, and high scores indicate that patients have good self-management.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- 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.
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 Application of computer-assisted cognitive rehabilitation program in people with Epilepsy and Computer-assisted Cognitive Rehabilitation, run by Selcuk 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 6 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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?
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?
Mini Mental State Test (time frame: 5 minutes). 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 19 Apr 2024.