- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509455
Balance Measures During Stance and Gait: Comparison of Gyroscopic Measurements of Trunk Sway
July 11, 2025 updated by: University Hospital, Basel, Switzerland
Quantified Balance Measures During Stance and Gait: Comparison of a New Micro-mechanical Gyro-system (Sensoro Von Hocoma AG) With SwayStar (Balance Int. Innov.) for Measurements of Balance Control of Healthy Controls.
To investigate whether an extended version of Valedo®Motion (termed Sensoro for brand management purposes), has the same trunk sway measures similar normal reference values of SwayStar.
Offline data analysis of data obtained from Sensoro will be compared to data obtained by SwayStar, a highly accurate and widely accepted system for measuring balance control.
Study Overview
Status
Recruiting
Conditions
Detailed Description
- Determine a long time recording (over 60s) description of any differences in the drift and noise for the 2 systems during simultaneous recordings with the systems aligned with each other at rest.
- Compare Sensoro trunk sway measures with those of SwayStar for a battery of 17 stance and gait tasks. The tasks to range from tasks with small velocities (standing on 2 legs eyes open, ca 0.1 deg/s or eyes closed on foam ca.10 deg/s) through tandem and gait tasks with velocities of ca 70 deg/s to the most dynamic with high velocities (rising from a chair, ca 150 deg/sec).
- Estimate the additional value of adding trunk sway values for the yaw axis as an outcome measure of balance control.
- Estimate the advantage of adding one or two sensors on the legs to help identify gait balance events and body posture.
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: John HJ Allum, DSc
- Phone Number: +41612652041
- Email: john.allum@usb.ch
Study Locations
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-
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Basel, Switzerland, 4056
- Recruiting
- Lab for Exp Otoneurology, University Hospital Basel
-
Contact:
- John HJ Allum, DSc
- Phone Number: +41612652041
- Email: john.allum@usb.ch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy adults
Description
Inclusion Criteria:
- self reported lack of balance problems (checked by the ability to stand on 1 leg, eyes closed, for at least 14 secs).
Exclusion Criteria:
- orthopaedic problems
- presence of diseases which cause balance problems.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Normal 1
SwayStar device used 1st, Sensoro used 2nd
|
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Normal 2
Sensoro device used 1st, SwayStar used 2nd
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk sway angular velocity and displacement stance and gait tasks.
Time Frame: 1 year
|
Is trunk sway angular velocity and displacement measured with SwayStar different when measured with Sensoro for a battery of stance and gait tasks
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John HJ Allum, DSc, University Hospital, Basel, Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
July 20, 2015
First Submitted That Met QC Criteria
July 27, 2015
First Posted (Estimated)
July 28, 2015
Study Record Updates
Last Update Posted (Actual)
July 16, 2025
Last Update Submitted That Met QC Criteria
July 11, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2015-071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.