NCT04200820

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

December 9, 2019

Last Update Submit

May 25, 2020

Conditions

Keywords

Sacculus

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

    5 minutes. At the start of the study and before the first elevator measurements the participants are asked to fill out the questionnaire.

Study Arms (1)

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.

Diagnostic Test: Trampoline

Interventions

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

Trampoline

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults
  • Signed informed consent after being informed

You may not qualify if:

  • Acute pain
  • Chronic neck pain
  • Undergone Neck surgery
  • Any vestibular disorder
  • Fear of elevators / claustrophobia
  • Dizziness handicap inventory score \>30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

  • Jaap Swanenburg, PhD

    University Hospital Zurich, Directorate of Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 16, 2019

Study Start

December 5, 2019

Primary Completion

March 1, 2020

Study Completion

March 10, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Publication

Locations