Alzheimer DiseaseNCT06575218
The Effectiveness of Virtual Reality Training Program
A study testing Virtual reality training and Conventional exercise and cognitive exercise in people with Alzheimer Disease, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
Alzheimer's disease is the most common type of dementia, accounting for 50% of all cases. Advanced age is a significant risk factor for AD. Virtual Reality (VR) is an interactive video game technology that provides computer-generated environments that include physical activity and provide users with experiences… Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Virtual reality training and Conventional exercise and cognitive exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2024to 6 Sep 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 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 55 years and older Diagnosed with AD according to DSM-IV diagnostic criteria by a neurologist, MOCA ≥ 16 Clinical Dementia Rating Scale < 2
Who cannot join
- Various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.) Clinically significant aphasia (must be able to understand the therapist's commands) Significant visual or sensory impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ebru Akbuğa Koç
Istanbul
Ebru Akbuğa Koç, 05548611344, ebruakbuga@gmail.com
Ebru Akbuğa Koç
About this study
Official title: The Effectiveness of Virtual Reality Training Program in Community Dwelling Older Adults With Alzheimer's Disease
Alzheimer's disease is the most common type of dementia, accounting for 50% of all cases. Advanced age is a significant risk factor for AD. Virtual Reality (VR) is an interactive video game technology that provides computer-generated environments that include physical activity and provide users with experiences similar to those in the real world. VR technology can be used for rehabilitation purposes in individuals with various orthopedic and neurological disorders due to its ability to enhance motor, cognitive learning and neural plasticity (1,2). The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community.
Read the detailed description
The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community. Prospective Randomized Controlled Single Blind Study After the patients and their relatives are informed in detail before the study, they will be asked whether they want to participate in the study and the individuals or relatives of the patients who approve of participating in the study will be asked to sign the informed consent form. Individuals who meet the inclusion criteria will be randomly divided into three groups by a single researcher: Virtual reality training program, cognitive exercise with traditional balance exercises, and traditional balance exercises only.
- Conditions
- Alzheimer Disease
- Being tested
- Virtual reality training, Conventional exercise and cognitive exercise, control
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality trainingDevice
Virtual reality training
Conventional exercise and cognitive exerciseOther
Conventional exercise and cognitive exercise
controlOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality training group | Experimental | It will be included in the virtual reality training program to be implemented with the Wii-fit console. Receives: Other: Conventional exercise and cognitive exercise; Other: control |
| Conventional exercise and cognitive exercise group | Experimental | It will be included in the cognitive exercise program along with conventional balance exercises. Receives: Device: Virtual reality training; Other: control |
| Control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal cognitive assessment scale
MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Measured: 12 weeks
Berg Balance Scale
BBS measures static and dynamic balance in elderly individuals
Measured: 12 weeks
Time up and Go Test
TUG test evaluates fall risk, mobility and physical performance in the elderly
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start21 May 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion6 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575218
- Sponsor's protocol ID
- YeditepeUni
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Reality Training Program in Community Dwelling Older Adults With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06575218
- Acronym / sponsor ID
- YeditepeUni
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 6 Sep 2024 (estimated)
- First posted
- 28 Aug 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.
Alzheimer's disease is the most common type of dementia, accounting for 50% of all cases. Advanced age is a significant risk factor for AD. Virtual Reality (VR) is an interactive video game technology that provides computer-generated environments that include physical activity and provide users with experiences similar to those in the real world. VR technology can be used for rehabilitation purposes in individuals with various orthopedic and neurological disorders due to its ability to enhance motor, cognitive learning and neural plasticity (1,2). The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community.
Detailed description
The aim of our study was to examine the effect of the Virtual Reality Training Program on cognition in individuals with Alzheimer's disease living in the community. Prospective Randomized Controlled Single Blind Study After the patients and their relatives are informed in detail before the study, they will be asked whether they want to participate in the study and the individuals or relatives of the patients who approve of participating in the study will be asked to sign the informed consent form. Individuals who meet the inclusion criteria will be randomly divided into three groups by a single researcher: Virtual reality training program, cognitive exercise with traditional balance exercises, and traditional balance exercises only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality training group | Experimental | Other: Conventional exercise and cognitive exercise, Other: controlIt will be included in the virtual reality training program to be implemented with the Wii-fit console. |
| Conventional exercise and cognitive exercise group | Experimental | Device: Virtual reality training, Other: controlIt will be included in the cognitive exercise program along with conventional balance exercises. |
| Control group | No intervention | –no intervention |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 55 years and older Diagnosed with AD according to DSM-IV diagnostic criteria by a neurologist, MOCA ≥ 16 Clinical Dementia Rating Scale < 2
Key exclusion criteria (1 listed)
- Various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.) Clinically significant aphasia (must be able to understand the therapist's commands) Significant visual or sensory impairment
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 |
|---|---|---|
| Virtual reality trainingVirtual reality training | Device | Conventional exercise and cognitive exercise group |
| Conventional exercise and cognitive exerciseConventional exercise and cognitive exercise | Other | Virtual reality training group |
| controlno intervention | Other | Conventional exercise and cognitive exercise group, Virtual reality training group |
Primary outcome
Montreal cognitive assessment scale
Time frame: 12 weeks
MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.
Berg Balance Scale
Time frame: 12 weeks
BBS measures static and dynamic balance in elderly individuals
Time up and Go Test
Time frame: 12 weeks
TUG test evaluates fall risk, mobility and physical performance in the elderly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality training and Conventional exercise and cognitive exercise in people with Alzheimer Disease, run by Yeditepe 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 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 30 Aug 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?
Contact Ebru Akbuga Koc (216, ebru.akbuga@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal cognitive assessment scale (time frame: 12 weeks). The study lists 3 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 30 Aug 2024.