Clinical trial NCT05890755: Mimicking Slipping Responses Using a Novel Mechanical Perturbation Algorithm
Official title: Mimicking Slipping Responses Using a Novel Mechanical Perturbation Algorithm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gait, Stumbling
Gait, Perturbation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy population

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.


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

Primary outcomes:
measure: Calculation of Margins of Stability (MoS) in anterior-posterior direction at foot contact
timeFrame: Once during visit 1
measure: Step length at baseline, before (Pre) and after (Recovery step 1-10) perturbation
timeFrame: Once during visit 1
Secondary outcomes:
measure: Step width at foot contact of baseline, before (Pre) and Recovery steps 1-10
timeFrame: Once during visit 1
measure: Calculation of Margin of stability medial-lateral direction at foot contact of baseline, before (Pre) and Recovery steps 1-10
timeFrame: Once during visit 1
measure: Maximal trunk velocity during gait cycle at of baseline, before (Pre) and Recovery steps 1-10 to detect fast trunk movement to gain balance
timeFrame: Once during visit 1
measure: 3D kinematic gait profiles to analyze detailed movement patterns/strategies
timeFrame: Once during visit 1
measure: EMG analysis to detect reaction time and activity patterns of different leg muscles
timeFrame: Once during visit 1
measure: Questionnaire regarding the incidence of falls in the last six months
timeFrame: Once during visit 1
measure: Activities specific Balance Confidence scale (ABC scale)
timeFrame: Once during visit 1
measure: Questionnaire regarding the perceived intensities of the three perturbation algorithms
timeFrame: Once during visit 1
measure: Functional Gait Assessment (FGA) as a clinical balance test
timeFrame: Once during visit 1
measure: A set of kinematic parameters
timeFrame: Once during visit 1
measure: A set of kinetic parameters
timeFrame: Once during visit 1
measure: A set of spatiotemporal parameters
timeFrame: Once during visit 1
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist Campus
Study officials:
affiliation: University of Zurich
name: Linard Filli, Dr.
role: PRINCIPAL_INVESTIGATOR
References: