Balance Measures During Stance and Gait: Comparison of Gyroscopic Measurements of Trunk Sway

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02509455
• Other study ID #: 2015-071
• Status: Recruiting
• Start date: June 2015
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: John HJ Allum, DSc
• Phone: +41612652041
• Email: john.allum[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

1. 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.

2. 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).

3. Estimate the additional value of adding trunk sway values for the yaw axis as an outcome measure of balance control.

4. Estimate the advantage of adding one or two sensors on the legs to help identify gait balance events and body posture.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Switzerland	Lab for Exp Otoneurology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trunk sway angular velocity and displacement stance and gait tasks.	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