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Clinical Trials/NCT05890755
NCT05890755
Completed
N/A

Mimicking Slipping Responses Using a Novel Mechanical Perturbation Algorithm

University of Zurich1 site in 1 country43 target enrollmentJune 6, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gait, Stumbling
Sponsor
University of Zurich
Enrollment
43
Locations
1
Primary Endpoint
Calculation of Margins of Stability (MoS) in anterior-posterior direction at foot contact
Status
Completed
Last Updated
8 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 6, 2023
End Date
December 6, 2024
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Calculation of Margins of Stability (MoS) in anterior-posterior direction at foot contact

Time Frame: Once during visit 1

Difference between base of support and interpolated center of mass (mm), based on 3D motion capture.

Step length at baseline, before (Pre) and after (Recovery step 1-10) perturbation

Time Frame: Once during visit 1

Secondary Outcomes

  • Activities specific Balance Confidence scale (ABC scale)(Once during visit 1)
  • Maximal trunk velocity during gait cycle at of baseline, before (Pre) and Recovery steps 1-10 to detect fast trunk movement to gain balance(Once during visit 1)
  • A set of kinematic parameters(Once during visit 1)
  • Calculation of Margin of stability medial-lateral direction at foot contact of baseline, before (Pre) and Recovery steps 1-10(Once during visit 1)
  • EMG analysis to detect reaction time and activity patterns of different leg muscles(Once during visit 1)
  • Step width at foot contact of baseline, before (Pre) and Recovery steps 1-10(Once during visit 1)
  • 3D kinematic gait profiles to analyze detailed movement patterns/strategies(Once during visit 1)
  • Questionnaire regarding the incidence of falls in the last six months(Once during visit 1)
  • A set of spatiotemporal parameters(Once during visit 1)
  • Questionnaire regarding the perceived intensities of the three perturbation algorithms(Once during visit 1)
  • Functional Gait Assessment (FGA) as a clinical balance test(Once during visit 1)
  • A set of kinetic parameters(Once during visit 1)

Study Sites (1)

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