Vestibular Function TestsNCT04200820
Changing Vertical Self-motion Perception
A study testing Trampoline in people with Vestibular Function Tests, run by University of Zurich at 1 site in Switzerland.
Trial summary
The objective of this study is to explore the "vertical self-motion perception" on in healthy young individuals using an elevator as accelerator. Secondary aim is to explore the effects of repeated vertical acceleration on vertical vestibular sensibility. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Function Tests
- What is being tested?
- Trampoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Dec 2019to 10 Mar 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults
- Signed informed consent after being informed
Who cannot join
- Acute pain
- Chronic neck pain
- Undergone Neck surgery
- Any vestibular disorder
- Fear of elevators / claustrophobia
- Dizziness handicap inventory score >30
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
Zurich, Canton of Zurich, 8091
About this study
Official title: Changing Vertical Self-motion Perception After Trampoline Jumping; Assessing Otolith Function in an Elevator
The objective of this study is to explore the "vertical self-motion perception" on in healthy young individuals using an elevator as accelerator. Secondary aim is to explore the effects of repeated vertical acceleration on vertical vestibular sensibility.
Read the detailed description
The detection of displacement is important information to maintaining balance, postural control, and gait during daily living activities. This detection of displacement or self-motion perception is accomplished by the human vestibular system, particularly the otolith organs, the sacculus and utriculus. Both primarily respond to whole-body acceleration or tilt in gravity. The saccule and utricle detect linear motion as well as the static orientation of the head relative to gravity, which is itself a linear acceleration. The saccule is more sensitive to vertical acceleration (sensing elevator acceleration) and the utricle is more sensitive to horizontal acceleration (sensing a car accelerate). The signals from the vestibular system are transmitted o the central nervous system for further processing.
Testing the otolith function is difficult since it always a combination of the tested inertial acceleration (t) and gravity (g). Therefore the Vector of acceleration is skew. An isolated vertical direction testing of the saccule is to our knowledge not done. Testing the function of the saccule in an elevator would eliminate the any horizontal accelerations other than gravity. Using the decelerations phase of an elevator ride during both up and down ride could give important inside of the self-motion perception (sensation of acceleration of a subject). The reaction force F which accts on the otolith would be maximal when the elevator ride downwards would stop. The force acting on the otolith when the elevator got upwards is breaking is smaller than g.
A better understanding the adaption of the self-motion perception could be beneficial for patients with hypersensitive vestibular functioning, e.g. patients with vestibular migraine. We hypothesized that (a) healthy subjects change the self-motion perception after hyper-stimulation with repeated vertical acceleration.
The objective of this study is to explore the "vertical self-motion perception" on in healthy young individuals using an elevator as accelerator. Secondary aim is to explore the effects of repeated vertical acceleration on vertical vestibular sensibility.
- Conditions
- Vestibular Function Tests
- Being tested
- Trampoline
- Keywords
- Sacculus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrampolineDiagnostic test
During trampoline training that participants undergo constant change of vestibular stimulation. This triggers deep proprioception as well as other sensory inputs. This trigger might affect strength, body stability, muscle coordinative responses, joint movement amplitudes and spatial integration
| Study group | Role | What they receive |
|---|---|---|
| Trampoline | Experimental | The participants will jump on a mini-trampoline for 30 seconds and then will have a 30 seconds break. This will be repeated 16 times. This resulted in a cumulative total intervention time of 8 minutes. Receives: Diagnostic Test: Trampoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Vertical Self-Motion Perception Reaction Time (VSMPT)
The VSMPT reflects the time in which a person's ability to sense vertical acceleration. A Raspberry Pi 3 B+ with an inertial measurement unit (IMU) will measure the vertical acceleration of the elevator's acceleration. The subject will be asked to stop the stopwatch he/she feels acceleration / deceleration of the elevator ride. The reaction time and the duration of acceleration / deceleration will be measured. Data will be collected starting on the ground floor as the elevator travelled up to a stop at the higher floor (12 floors up). Thereafter the down ride will be measured.Five-elevator rides up and five down will be measured.
Measured: Changes from before and after the elevator rides will be assessed. The assessments will be executed one minute before and after the trampoline intervention. One assessment will take 15 minutes.
Secondary outcomes (2)
Self-administered neck mobility assessment tool (S-ROM-Neck)
The S-ROM-Neck questionnaire is a self-administered questionnaire that uses visual analog scales (VAS) to measure pain-free active range of motion (ROM) for all neck movements. The patient is asked to place a mark on a 100 mm line (0 mm = "no movement possible" and 100 mm = "as far as possible"). The total score is the sum of the individual scores (min. score (600) = no restrictions and max. score (0) = total restriction)
Measured: 5 minutes. At the start of the study and before the first elevator measurements the participants are asked to fill out the questionnaire.
Dizziness handicap inventory (DHI)
The DHI is a validated, 25-item-self-report questionnaire to evaluate the self-perceived handicapping effects caused by dizziness. The DHI is categorized in three domains; functional (9 questions, 36 points), emotional (9 questions, 36 points) and physical (7 questions, 28 points). Patients will answer the questions with no (0 points), sometimes (2 points) and yes (4 points). The higher the score, the greater the handicap caused by dizziness.
Measured: 5 minutes. At the start of the study and before the first elevator measurements the participants are asked to fill out the questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start5 Dec 2019
- Primary completion1 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular Function TestsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaap Swanenburg, PhD, Principal investigator, University Hospital Zurich, Directorate of Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200820
- Sponsor's protocol ID
- BASEC-Nr: 2019-01759
- Status last verified
- May 2020
- First submitted
- 9 Dec 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Vertical Self-motion Perception After Trampoline Jumping; Assessing Otolith Function in an Elevator
- ClinicalTrials.gov ID
- NCT04200820
- Acronym / sponsor ID
- BASEC-Nr: 2019-01759
- Conditions
- Vestibular Function Tests
- Keywords
- Sacculus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 16 Dec 2019 (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 objective of this study is to explore the "vertical self-motion perception" on in healthy young individuals using an elevator as accelerator. Secondary aim is to explore the effects of repeated vertical acceleration on vertical vestibular sensibility.
Detailed description
The detection of displacement is important information to maintaining balance, postural control, and gait during daily living activities. This detection of displacement or self-motion perception is accomplished by the human vestibular system, particularly the otolith organs, the sacculus and utriculus. Both primarily respond to whole-body acceleration or tilt in gravity. The saccule and utricle detect linear motion as well as the static orientation of the head relative to gravity, which is itself a linear acceleration. The saccule is more sensitive to vertical acceleration (sensing elevator acceleration) and the utricle is more sensitive to horizontal acceleration (sensing a car accelerate). The signals from the vestibular system are transmitted o the central nervous system for further processing.
Testing the otolith function is difficult since it always a combination of the tested inertial acceleration (t) and gravity (g). Therefore the Vector of acceleration is skew. An isolated vertical direction testing of the saccule is to our knowledge not done. Testing the function of the saccule in an elevator would eliminate the any horizontal accelerations other than gravity. Using the decelerations phase of an elevator ride during both up and down ride could give important inside of the self-motion perception (sensation of acceleration of a subject). The reaction force F which accts on the otolith would be maximal when the elevator ride downwards would stop. The force acting on the otolith when the elevator got upwards is breaking is smaller than g.
A better understanding the adaption of the self-motion perception could be beneficial for patients with hypersensitive vestibular functioning, e.g. patients with vestibular migraine. We hypothesized that (a) healthy subjects change the self-motion perception after hyper-stimulation with repeated vertical acceleration.
The objective of this study is to explore the "vertical self-motion perception" on in healthy young individuals using an elevator as accelerator. Secondary aim is to explore the effects of repeated vertical acceleration on vertical vestibular sensibility.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trampoline | Experimental | Diagnostic Test: TrampolineThe participants will jump on a mini-trampoline for 30 seconds and then will have a 30 seconds break. This will be repeated 16 times. This resulted in a cumulative total intervention time of 8 minutes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy young adults
- Signed informed consent after being informed
Key exclusion criteria (6 listed)
- Acute pain
- Chronic neck pain
- Undergone Neck surgery
- Any vestibular disorder
- Fear of elevators / claustrophobia
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 |
|---|---|---|
| TrampolineDuring trampoline training that participants undergo constant change of vestibular stimulation. This triggers deep proprioception as well as other sensory inputs. This trigger might affect strength, body stability, muscle coordinative responses, joint movement amplitudes and spatial integration | Diagnostic test | Trampoline |
Primary outcome
Change of Vertical Self-Motion Perception Reaction Time (VSMPT)
Time frame: Changes from before and after the elevator rides will be assessed. The assessments will be executed one minute before and after the trampoline intervention. One assessment will take 15 minutes.
The VSMPT reflects the time in which a person's ability to sense vertical acceleration. A Raspberry Pi 3 B+ with an inertial measurement unit (IMU) will measure the vertical acceleration of the elevator's acceleration. The subject will be asked to stop the stopwatch he/she feels acceleration / deceleration of the elevator ride. The reaction time and the duration of acceleration / deceleration will be measured. Data will be collected starting on the ground floor as the elevator travelled up to a stop at the higher floor (12 floors up). Thereafter the down ride will be measured.Five-elevator rides up and five down will be measured.
2 secondary outcomes
Self-administered neck mobility assessment tool (S-ROM-Neck)
Time frame: 5 minutes. At the start of the study and before the first elevator measurements the participants are asked to fill out the questionnaire.
Dizziness handicap inventory (DHI)
Time frame: 5 minutes. At the start of the study and before the first elevator measurements the participants are asked to fill out the questionnaire.
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 27 May 2020.
- Individual participant dataSharing planned: No. Publication
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.
Jaap Swanenburg, PhD principal investigator
University Hospital Zurich, Directorate of Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trampoline in people with Vestibular Function Tests, run by University of Zurich at 1 site in Switzerland.
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 6 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 27 May 2020. 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 Switzerland. 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?
Change of Vertical Self-Motion Perception Reaction Time (VSMPT) (time frame: Changes from before and after the elevator rides will be assessed. The assessments will be executed one minute before and after the trampoline intervention. One assessment will take 15 minutes.). 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 27 May 2020; AzTrials last refreshed its copy on 27 Oct 2026.