Age-Related Memory DisordersNCT04819126
Nintendo Wii Virtual Reality Application In Dementia
A study testing Nintendo Wii Virtual Reality Application in people with Age-Related Memory Disorders, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
•This study was planned to investigate the effects of the Nintendo Wii virtual reality application on muscle strength and fall risk in individuals with AD. The aim of the present study is to investigate the effect of the virtual reality application on muscle strength and fall in individuals with Alzheimer' Dementia… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Age-Related Memory Disorders
- What is being tested?
- Nintendo Wii Virtual Reality Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2018to 15 Jan 2019
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- included volunteers between the ages of 65-80 with mild or moderate AD diagnosis,
- who did not have any difficulty or problems in communicating,
- who did not have any neurological diseases that disrupt balance and coordination such as a cerebrovascular event, Parkinson's disease, Multiple Sclerosis, and neurological disorder,
- who obtained a score of 18 - 24 points in the Mini-Mental State Test (MMST)
Who cannot join
- Patients diagnosed with rapidly progressing dementia (infection, vascular, hematologic diseases),
- Those who could not be contacted during the follow-up period or who did not participate in the training session, those who experienced cardiac and cerebrovascular events, endocrine disorders, fluid-electrolyte imbalance and infection,
- Those with malignancy and those who received chemotherapy and radiotherapy that causes malignancy, delirium or depression and malignant sensory loss (those with the Semmes-Weinstein monofilament thickness of 4.56 and above),
- Those with a lower or upper extremity amputation at any level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia
•This study was planned to investigate the effects of the Nintendo Wii virtual reality application on muscle strength and fall risk in individuals with AD.
The aim of the present study is to investigate the effect of the virtual reality application on muscle strength and fall in individuals with Alzheimer' Dementia (AD).
Read the detailed description
Purpose: This study was planned to investigate the effects of the Nintendo Wii virtual reality application on muscle strength and fall risk in individuals with AD.
Method: The study included a total of 32 volunteers between the ages of 65-80, with mild or moderate AD diagnosed. These individuals were divided into 2 groups as a training group and control group. The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes. Mini-Mental State Test, Knee Extension Muscle Strength, Timed Up and Go Test, Tinetti Falls Efficacy Scale results of individuals were recorded in the evaluation.
- Conditions
- Age-Related Memory Disorders
- Being tested
- Nintendo Wii Virtual Reality Application
- Keywords
- Alzheimer's Dementia, Muscle strength, Fall, Virtual reality
- Medical subject headings
- Memory Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Wii Virtual Reality ApplicationOther
The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia | Experimental | The study included a total of 32 volunteers between the ages of 65-80, who stayed in Karaman Ahmet Mete Nursing Home, Elderly Care and Rehabilitation Center, with mild or moderate Alzheimer's dementia diagnosed by a neurologist. As a result of the power analysis, it was calculated that at least 16 individuals could be included in each group (at least 32 individuals in total). Randomization was performed by the sealed-envelope method. According to this method, 4 females and 12 males were determined to be in the control group, while 5 females and 11 males were determined to be in the training group.
The evaluation was completed before the intervention. The same evaluation was conducted after 6 weeks.
The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes, and each patient was trained with the same games. Receives: Other: Nintendo Wii Virtual Reality Application |
| Older People With Alzheimer's Dementia | No intervention | In the control group, no application was performed during this period, and routine medical treatments were continued. The training group was evaluated before and after the training, while the control group was re-evaluated at the end of the 6th week after the first evaluation. After the study was completed, the volunteers from the control group were also given training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age :mean or median age
Age, Categorical:
>=65 years
Measured: period of 6 weeks
Body Mass Index
BMI was recorded in kg/m^2.
Measured: period of 6 weeks
Sex/Gender
Sex: Female, Male
Measured: period of 6 weeks
Secondary outcomes (1)
The Mini-Mental State Test for Cognitive status
According to the MMST, 24-30 points were considered as normal cognitive levels, 18-23 points were considered as mild cognitive disorders, and 0-17 points were considered as severe cognitive disorders
Measured: period of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start15 Jan 2018
- Primary completion6 Jun 2018
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Memory DisordersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral SERTEL, Kırıkkale University
- Investigators
- Konya Karaman Ahmet Mete Nursing Home, Principal investigator, Karaman Ahmet Mete Nursing Home. Konya in Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819126
- Sponsor's protocol ID
- Karamanoğlu Mehmet Bey U
- Other IDs
- Kırıkkale University
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 26 Mar 2021
- 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 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia
- ClinicalTrials.gov ID
- NCT04819126
- Acronym / sponsor ID
- Karamanoğlu Mehmet Bey U
- Conditions
- Age-Related Memory Disorders
- Keywords
- Alzheimer's Dementia, Muscle strength, Fall, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 26 Mar 2021 (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.
•This study was planned to investigate the effects of the Nintendo Wii virtual reality application on muscle strength and fall risk in individuals with AD.
The aim of the present study is to investigate the effect of the virtual reality application on muscle strength and fall in individuals with Alzheimer' Dementia (AD).
Detailed description
Purpose: This study was planned to investigate the effects of the Nintendo Wii virtual reality application on muscle strength and fall risk in individuals with AD.
Method: The study included a total of 32 volunteers between the ages of 65-80, with mild or moderate AD diagnosed. These individuals were divided into 2 groups as a training group and control group. The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes. Mini-Mental State Test, Knee Extension Muscle Strength, Timed Up and Go Test, Tinetti Falls Efficacy Scale results of individuals were recorded in the evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia | Experimental | Other: Nintendo Wii Virtual Reality ApplicationThe study included a total of 32 volunteers between the ages of 65-80, who stayed in Karaman Ahmet Mete Nursing Home, Elderly Care and Rehabilitation Center, with mild or moderate Alzheimer's dementia diagnosed by a neurologist. As a result of the power analysis, it was calculated that at least 16 individuals could be included in each group (at least 32 individuals in total). Randomization was performed by the sealed-envelope method. According to this method, 4 females and 12 males were determined to be in the control group, while 5 females and 11 males were determined to be in the training group. The evaluation was completed before the intervention. The same evaluation was conducted after 6 weeks. The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes, and each patient was trained with the same games. |
| Older People With Alzheimer's Dementia | No intervention | –In the control group, no application was performed during this period, and routine medical treatments were continued. The training group was evaluated before and after the training, while the control group was re-evaluated at the end of the 6th week after the first evaluation. After the study was completed, the volunteers from the control group were also given training. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- included volunteers between the ages of 65-80 with mild or moderate AD diagnosis,
- who did not have any difficulty or problems in communicating,
- who did not have any neurological diseases that disrupt balance and coordination such as a cerebrovascular event, Parkinson's disease, Multiple Sclerosis, and neurological disorder,
- who obtained a score of 18 - 24 points in the Mini-Mental State Test (MMST)
Key exclusion criteria (4 listed)
- Patients diagnosed with rapidly progressing dementia (infection, vascular, hematologic diseases),
- Those who could not be contacted during the follow-up period or who did not participate in the training session, those who experienced cardiac and cerebrovascular events, endocrine disorders, fluid-electrolyte imbalance and infection,
- Those with malignancy and those who received chemotherapy and radiotherapy that causes malignancy, delirium or depression and malignant sensory loss (those with the Semmes-Weinstein monofilament thickness of 4.56 and above),
- Those with a lower or upper extremity amputation at any level
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 |
|---|---|---|
| Nintendo Wii Virtual Reality ApplicationThe training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes. | Other | Nintendo Wii Virtual Reality Application In Older People With Alzheimer's Dementia |
Primary outcome
Age :mean or median age
Time frame: period of 6 weeks
Age, Categorical: >=65 years
Body Mass Index
Time frame: period of 6 weeks
BMI was recorded in kg/m^2.
Sex/Gender
Time frame: period of 6 weeks
Sex: Female, Male
1 secondary outcome
The Mini-Mental State Test for Cognitive status
Time frame: period of 6 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 26 Mar 2021.
- Individual participant dataSharing planned: No
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.
Konya Karaman Ahmet Mete Nursing Home principal investigator
Karaman Ahmet Mete Nursing Home. Konya in Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nintendo Wii Virtual Reality Application in people with Age-Related Memory Disorders, run by Kırıkkale 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 4 inclusion and 4 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 26 Mar 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?
Age :mean or median age (time frame: period of 6 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 26 Mar 2021; AzTrials last refreshed its copy on 31 Oct 2026.