Mimicking Slipping Responses Using a Novel Mechanical Perturbation Algorithm

Gait, Stumbling Clinical Trial

Official title:

Mimicking Slipping Responses Using a Novel Mechanical Perturbation Algorithm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890755
• Other study ID #: 2023-00213
• Status: Recruiting
• Start date: June 6, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2023
• Source: University of Zurich
• Contact: Linard Filli, Dr.
• Phone: +41 44 510 72 12
• Email: linard.filli[@]balgrist.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Healthy subjects will be invited to fill out a questionnaire regarding falls and balance skills followed by normal walking trials on a treadmill at 9 different speeds (0.28-1.4 m/s). Key gait parameters for the normative database will be collected. During the perturbation trials, the subjects will walk at a constant speed (1.2 m/s). The treadmill belts are ac, - or decelerated during the perturbations according to three different perturbation algorithms with varying perturbation onset. Movements will be analyzed by 3D motion capture, force plates, surface electromyography and IMU sensors. All methods are non-invasive and commonly used in the field of biomechanics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy subjects aged 18-40 years and 60-80 years

• Ability to walk at minimum 30 minutes at a regular pace without assistance or breaks

• Written informed consent as documented by signature (see informed consent form)

Exclusion Criteria:

• Women who are pregnant or breast feeding

• Current neurological problems affecting walking function and balance

• Current orthopedic problems affecting upper and lower extremity movements

• History of alcohol abuse or the intake of psychotropic drugs

• History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))

• History of major pulmonary condition (e.g., chronic obstructive pulmonary disease (GOLD II-IV))

• Current major depression or psychosis

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia

• Fever of unknown origin

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Stumbling

Intervention

Other:
• Mechanical pertubation
Acceleration or deacceleration of one treadmill gait belt.

Locations

Country	Name	City	State
Switzerland	Balgrist Campus	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculation of Margins of Stability (MoS) in anterior-posterior direction at foot contact	Difference between base of support and interpolated center of mass (mm), based on 3D motion capture.	Once during visit 1
Primary	Step length at baseline, before (Pre) and after (Recovery step 1-10) perturbation		Once during visit 1
Secondary	Step width at foot contact of baseline, before (Pre) and Recovery steps 1-10		Once during visit 1
Secondary	Calculation of Margin of stability medial-lateral direction at foot contact of baseline, before (Pre) and Recovery steps 1-10	Difference between base of support and interpolated center of mass (mm), based on 3D motion capture.	Once during visit 1
Secondary	Maximal trunk velocity during gait cycle at of baseline, before (Pre) and Recovery steps 1-10 to detect fast trunk movement to gain balance	Optical markers are placed on the upper body of the subjects and will be used for calculation (distance over time) of the trunk velocity.	Once during visit 1
Secondary	3D kinematic gait profiles to analyze detailed movement patterns/strategies	The optical markers are placed according to the Plug-in gait marker set in Vicon Nexus (motion capture system). Hip, knee, ankle and trunk angles are calculated from this marker set.	Once during visit 1
Secondary	EMG analysis to detect reaction time and activity patterns of different leg muscles		Once during visit 1
Secondary	Questionnaire regarding the incidence of falls in the last six months	Contains questions how often und the reason why the subject falls	Once during visit 1
Secondary	Activities specific Balance Confidence scale (ABC scale)	Contains 16 questions rating the balance confidence between 0-100%. 100% means absolutely confident in doing some activity	Once during visit 1
Secondary	Questionnaire regarding the perceived intensities of the three perturbation algorithms	Judging the three pertubation algorithms according to their intensity, inconvenience and how realistic the slipping felt. Scale ranges from 0-10, whereas 10 is the most intense	Once during visit 1
Secondary	Functional Gait Assessment (FGA) as a clinical balance test	Assess the dynamic stability during different walking tasks. In total, 30 points are possible, at 22 points is the cut off score to classify the fall risk in older adults in predicting falls.	Once during visit 1
Secondary	A set of kinematic parameters	Measurement of hip, knee, ankle and spine angles during walking in degrees (°).	Once during visit 1
Secondary	A set of kinetic parameters	Ground reaction forces measured by force plates in Newton (N).	Once during visit 1
Secondary	A set of spatiotemporal parameters	Stance time, double stance time in seconds (s).	Once during visit 1