Distorted; BalanceNCT02214342
Virtual Reality Based Balance Training in People With Mild Cognitive Impairment
A study testing Balance Training in people with Distorted; Balance and Motor Deficit, run by University of Arizona at 1 site in United States.
Trial summary
The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in people with mild cognitive impairment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Distorted; Balance, Motor Deficit, Cognitive Deficit
- What is being tested?
- Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of Mild Cognitive Impairment
- willingness to provide informed consent
Who cannot join
- severe neurologic, cardiovascular, metabolic, or psychiatric disorders
- severe visual impairment
- severe cognitive impairment
- dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner Sun Health Research Institute
Sun City, Arizona, 85351
About this study
Official title: Virtual Reality Based Balance Training in People With Mild Cognitive Impairment: A Pilot Study
The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in people with mild cognitive impairment.
The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in people with mild cognitive impairment compared to a control group receiving usual care only.
- Conditions
- Distorted; Balance, Motor Deficit, Cognitive Deficit
- Being tested
- Balance Training
- Medical subject headings
- Neurologic Manifestations, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance TrainingOther
Experimental: Balance Training Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Balance Training | Experimental | Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes. Receives: Other: Balance Training |
| Control | No intervention | The control group will keep their normal activity without receiving any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Balance
Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)
Measured: 4 weeks
Secondary outcomes (5)
Gait performance
Gait performance will be measured using validated wearable sensor technology (LEGSys™)
Measured: 4 weeks
Cognitive status
Changes in cognitive status will be measured by the Trail Making Test
Measured: 4 weeks
Fear of falling
Fear of falling will be measured by the Falls Efficacy scale international (short form)
Measured: 4 weeks
User experience
User experience will be measured using a standardized questionaire
Measured: 4 weeks
Depressive signs
Depressive signs will be measured using the Center for Epidemiologic Studies Depression Scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distorted; BalanceStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Banner Health
- Responsible party
- Sponsor
- Investigators
- Bijan Najafi, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214342
- Sponsor's protocol ID
- 1401199972
- Status last verified
- Dec 2014
- First submitted
- 8 Aug 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Based Balance Training in People With Mild Cognitive Impairment: A Pilot Study
- ClinicalTrials.gov ID
- NCT02214342
- Acronym / sponsor ID
- 1401199972
- Conditions
- Distorted; Balance, Motor Deficit, Cognitive Deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Banner Health
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Aug 2014 (estimated)
- 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 the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in people with mild cognitive impairment.
The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in people with mild cognitive impairment compared to a control group receiving usual care only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Training | Experimental | Other: Balance TrainingBalance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes. |
| Control | No intervention | –The control group will keep their normal activity without receiving any intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of Mild Cognitive Impairment
- willingness to provide informed consent
Key exclusion criteria (4 listed)
- severe neurologic, cardiovascular, metabolic, or psychiatric disorders
- severe visual impairment
- severe cognitive impairment
- dementia
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 |
|---|---|---|
| Balance TrainingExperimental: Balance Training Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes. | Other | Balance Training |
Primary outcome
Postural Balance
Time frame: 4 weeks
Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)
5 secondary outcomes
Gait performance
Time frame: 4 weeks
Cognitive status
Time frame: 4 weeks
Fear of falling
Time frame: 4 weeks
User experience
Time frame: 4 weeks
Depressive signs
Time frame: 4 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 16 Dec 2014.
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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.
Bijan Najafi, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training in people with Distorted; Balance and Motor Deficit, run by University of Arizona at 1 site in United States.
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 2 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 16 Dec 2014. 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 United States. 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?
Postural Balance (time frame: 4 weeks). 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 16 Dec 2014.