Virtual RehabilitationNCT03175588
Comparison of Effects of Interactive Video Games in the Elderly
A study testing Virtual Rehabilitation in people with Virtual Rehabilitation, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to assess the effectiveness of interactive video-games on mobility and wellbeing and to compare them with activity-based approaches in geriatric population. 100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Rehabilitation
- What is being tested?
- Virtual Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2017to 30 Jun 2018
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- mini mental test score abowe 21 age between 65 and 85
Who cannot join
- neurological disorders orthopedical problems
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects of Interactive Video Games and Activity Based Approaches on Mobility and General Well Being in the Elderly
The aim of this study is to assess the effectiveness of interactive video-games on mobility and wellbeing and to compare them with activity-based approaches in geriatric population.
100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Persons will be placed in the study groups in consideration of their interests. One group will be included in Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation, and video-games will run for 30 minutes two days a week for 8 weeks. The other group will participate a program consisting of various physical activities for the same duration; The results of both groups will be compared with a control group.
Read the detailed description
100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Persons will be placed in the study groups in consideration of their interests. One group will be included in Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation, and video-games will run for 30 minutes two days a week for 8 weeks. The other group will participate a program consisting of various physical activities for the same duration; The results of both groups will be compared with a control group.
- Conditions
- Virtual Rehabilitation
- Being tested
- Virtual Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RehabilitationOther
Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation will be used
| Study group | Role | What they receive |
|---|---|---|
| virtual rehabilitation | Experimental | video based exercise Receives: Other: Virtual Rehabilitation |
| physical Activity | No intervention | different type of physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Balance measurement
Measured: 5 minute
Secondary outcomes (3)
10-meter walking test
functional ability and balancing
Measured: 3 minute
WHQOL-Bref
quality of life
Measured: 15 minute
Hamilton Depression Scale
Assessment of emotional situation
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start11 Sep 2017
- Primary completion11 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RehabilitationStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There will be three groups in this study. Two intervention and one control gruop to be compared after the intervention.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur CICEK, Istanbul University
- Investigators
- Arzu Razak Ozdincler, Prof, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175588
- Sponsor's protocol ID
- 08.02.2017 / 52639
- Status last verified
- Feb 2019
- First submitted
- 1 Jun 2017
- Last updated
- 26 Feb 2019
- 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 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Interactive Video Games and Activity Based Approaches on Mobility and General Well Being in the Elderly
- ClinicalTrials.gov ID
- NCT03175588
- Acronym / sponsor ID
- 08.02.2017 / 52639
- Conditions
- Virtual Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 11 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 5 Jun 2017 (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 assess the effectiveness of interactive video-games on mobility and wellbeing and to compare them with activity-based approaches in geriatric population.
100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Persons will be placed in the study groups in consideration of their interests. One group will be included in Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation, and video-games will run for 30 minutes two days a week for 8 weeks. The other group will participate a program consisting of various physical activities for the same duration; The results of both groups will be compared with a control group.
Detailed description
100 people living in Bahcelievler nursing home will be evaluated and volunteers who meet the criteria will be included in the study. Persons will be placed in the study groups in consideration of their interests. One group will be included in Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation, and video-games will run for 30 minutes two days a week for 8 weeks. The other group will participate a program consisting of various physical activities for the same duration; The results of both groups will be compared with a control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be three groups in this study. Two intervention and one control gruop to be compared after the intervention.
| Arm | Type | Receives |
|---|---|---|
| virtual rehabilitation | Experimental | Other: Virtual Rehabilitationvideo based exercise |
| physical Activity | No intervention | –different type of physical Activity |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- mini mental test score abowe 21 age between 65 and 85
Key exclusion criteria (2 listed)
- neurological disorders orthopedical problems
- -
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 RehabilitationNintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation will be used | Other | virtual rehabilitation |
Primary outcome
Berg Balance Scale
Time frame: 5 minute
Balance measurement
3 secondary outcomes
10-meter walking test
Time frame: 3 minute
WHQOL-Bref
Time frame: 15 minute
Hamilton Depression Scale
Time frame: 15 minute
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 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Virtual Rehabilitation
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
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.
Arzu Razak Ozdincler, Prof study director
Istanbul 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 Virtual Rehabilitation in people with Virtual Rehabilitation, run by Istanbul 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 2 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 Feb 2019. 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?
Berg Balance Scale (time frame: 5 minute). 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 Feb 2019.