Physical ActivityNCT03312790
Effects of Augmented Reality on Humans
A study testing Tasks in people with Physical Activity and Mental Status Change, run by University of Burgundy at 1 site in France.
Trial summary
Nowadays, augmented reality (AR) has gained attention but little is known concerning its repercussion in individuals when considering some mental and physiological aspects. Therefore, the aim of this study was to investigate the effects of AR glasses on some cognitive and physiological functions in an attempt to… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Mental Status Change
- What is being tested?
- Tasks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 1 Mar 2017
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- BMI < 27
- physically active
- informed consent written form
Who cannot join
- in-habitual fatigue
- taking drugs and alcohol more than twice a day
- potential psychomotor disease
- injury in the preceding 3 months
- no healthcare
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Expertise de la Performance - Université de Bourgogne
Dijon, 27877
About this study
Official title: Effects of Augmented Reality Glasses on Muscle Activity, Balance, Physical and Mental Fatigue
Nowadays, augmented reality (AR) has gained attention but little is known concerning its repercussion in individuals when considering some mental and physiological aspects. Therefore, the aim of this study was to investigate the effects of AR glasses on some cognitive and physiological functions in an attempt to determine its safety for workers.
Read the detailed description
Twelve volunteers were tested during two separate randomized sessions: one with AR glasses (ARGlass) and one in normal condition (Normal). Participants had two perform different tasks of a 90 minutes total duration. Before, during and after these tasks, two feet balance, one foot balance, precision balance, stroop and memory tests were performed. Also, heart rate and electromyographic activity of some muscles were recorded. Finally a survey was filled to determine, for example fatigue, pain or comfort.
- Conditions
- Physical Activity, Mental Status Change
- Being tested
- Tasks
- Keywords
- augmented reality, fatigue, muscle, heart rate, mental function
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasksDevice
Also called Workers tasks
Augmented reality device Real condition
| Study group | Role | What they receive |
|---|---|---|
| augmented reality device | Experimental | Tasks realized using augmented reality device Receives: Device: Tasks |
| Real condition | Other | Same tasks than augmented reality realized in normal/real condition Receives: Device: Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary activation using electromyography of upper and lower limb muscles
The mean electromyographic activity of trapezius, deltoideus, biceps brachii, latissimus dorsi, soleus and tibialis anterior muscles will be measured using surface electrodes
Measured: Measured just before and immediately after every 30 minutes series (repeated three times)
Secondary outcomes (7)
Heart rate
Heart rate during the different tasks and test session
Measured: Measured just before and immediately after every 30 minutes series (repeated three times)
Balance
Two feet, one foot and precision tasks balance (center of pressure displacement)
Measured: Measured just before and immediately after every 30 minutes series (repeated three times)
Memory
5 words memory test
Measured: Measured just before and immediately after every 30 minutes series (repeated three times)
attention
Stroop test
Measured: Measured just before and immediately after every 30 minutes series (repeated three times)
subjective perceived exertion
difficulty of the tasks using a visual analogic scale
Measured: Measured just before and immediately after every 30 minutes series (repeated three times)
subjective pain perception
pain perceived (visual analogic scale) and the location if some pain sensation
Measured: Measured just before and immediately after every 30 minutes series (repeated three times)
subjective fatigue perception
perceived fatigue (visual analogic scale) and the location in case of fatigue feeling
Measured: Measured just before and immediately after every 30 minutes series (repeated three times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Feb 2017
- Primary completion15 Feb 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Babault, University of Burgundy
- Investigators
- Nicolas Babault, PhD, Principal investigator, University of Burgundy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312790
- Sponsor's protocol ID
- CEP1701
- Status last verified
- Oct 2017
- First submitted
- 13 Jun 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Babault N, Paizis C, Deley G, Guerin-Deremaux L, Saniez MH, Lefranc-Millot C, Allaert FA. Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein. J Int Soc Sports Nutr. 2015 Jan 21;12(1):3. doi: 10.1186/s12970-014-0064-5. eCollection 2015.
PubMed 25628520
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Augmented Reality Glasses on Muscle Activity, Balance, Physical and Mental Fatigue
- ClinicalTrials.gov ID
- NCT03312790
- Acronym / sponsor ID
- CEP1701
- Conditions
- Physical Activity, Mental Status Change
- Keywords
- augmented reality, fatigue, muscle, heart rate, mental function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 18 Oct 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.
Nowadays, augmented reality (AR) has gained attention but little is known concerning its repercussion in individuals when considering some mental and physiological aspects. Therefore, the aim of this study was to investigate the effects of AR glasses on some cognitive and physiological functions in an attempt to determine its safety for workers.
Detailed description
Twelve volunteers were tested during two separate randomized sessions: one with AR glasses (ARGlass) and one in normal condition (Normal). Participants had two perform different tasks of a 90 minutes total duration. Before, during and after these tasks, two feet balance, one foot balance, precision balance, stroop and memory tests were performed. Also, heart rate and electromyographic activity of some muscles were recorded. Finally a survey was filled to determine, for example fatigue, pain or comfort.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| augmented reality device | Experimental | Device: TasksTasks realized using augmented reality device |
| Real condition | Other | Device: TasksSame tasks than augmented reality realized in normal/real condition |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- BMI < 27
- physically active
- informed consent written form
Key exclusion criteria (5 listed)
- in-habitual fatigue
- taking drugs and alcohol more than twice a day
- potential psychomotor disease
- injury in the preceding 3 months
- no healthcare
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 |
|---|---|---|
| TasksAlso: Workers tasksAugmented reality device Real condition | Device | Real condition, augmented reality device |
Primary outcome
Voluntary activation using electromyography of upper and lower limb muscles
Time frame: Measured just before and immediately after every 30 minutes series (repeated three times)
The mean electromyographic activity of trapezius, deltoideus, biceps brachii, latissimus dorsi, soleus and tibialis anterior muscles will be measured using surface electrodes
7 secondary outcomes
Heart rate
Time frame: Measured just before and immediately after every 30 minutes series (repeated three times)
Balance
Time frame: Measured just before and immediately after every 30 minutes series (repeated three times)
Memory
Time frame: Measured just before and immediately after every 30 minutes series (repeated three times)
attention
Time frame: Measured just before and immediately after every 30 minutes series (repeated three times)
subjective perceived exertion
Time frame: Measured just before and immediately after every 30 minutes series (repeated three times)
subjective pain perception
Time frame: Measured just before and immediately after every 30 minutes series (repeated three times)
subjective fatigue perception
Time frame: Measured just before and immediately after every 30 minutes series (repeated three times)
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 18 Oct 2017.
- Background: PubMed 25628520Babault N, Paizis C, Deley G, Guerin-Deremaux L, Saniez MH, Lefranc-Millot C, Allaert FA. Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein. J Int Soc Sports Nutr. 2015 Jan 21;12(1):3. doi: 10.1186/s12970-014-0064-5. eCollection 2015.
- centre d'expertise de la performanceLink provided by the sponsor.
- 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.
Nicolas Babault, PhD principal investigator
University of Burgundy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tasks in people with Physical Activity and Mental Status Change, run by University of Burgundy at 1 site in France.
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 5 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 18 Oct 2017. 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 France. 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?
Voluntary activation using electromyography of upper and lower limb muscles (time frame: Measured just before and immediately after every 30 minutes series (repeated three times)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312790, which also lists 1 linked publication.
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 18 Oct 2017.