Variability and Specificity in Reactive Stabilization Movements to Diverse Slip Perturbations

May 7, 2025 updated by: University of Nebraska

Recent research on slips has shown that use of perturbation training to improve specific motor skills to resist slips can vastly reduce falls. However, these interventions have only addressed slips occurring at heel-strike, and not the diverse range of slipping disturbances presented by a complex environment. This project will focus on slips that occur across the gait cycle, and the reactive stabilization movements that follow.

Participants from two age groups will be enrolled: younger (19 - 35 years of age) and older (65-79 years of age). Each participant will participate in 3 visits within the span of 1 week. On the initial visit, participants will perform informed consent, have demographic and body measurement information collected and complete medical and physical activity questionnaires. Upper and lower body strength will be measured using a hand-held dynamometer during the first and last visits. On each of the three visits, subjects will perform a gait variability assessment followed by a diverse slip perturbation assessment. Participants will complete four slips in each of early, middle, and late stance on each visit. Measures of falls, slip severity, and reactive stabilization movements will be calculated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Recent research on slips has shown that use of perturbation training to improve specific motor skills to resist slips can vastly reduce falls. However, these interventions have only addressed slips occurring at heel-strike, and not the diverse range of slipping disturbances presented by a complex environment. This study will focus on slips that occur across the gait cycle, and the reactive stabilization movements that follow. Slips at different phases of the gait cycle have unique biomechanical contexts, and successful reactive stabilization movements are likely to be highly specific to that context. Yet nothing is known about the specificity of the repertoire of reactive stabilization movements to resist different slip conditions. Furthermore, variability in the repertoire of reactive stabilization movements is likely to affect the success/failure rate of resisting these disturbances. Thus, the objective of the proposed study is to determine the roles of variability and specificity in reactive stabilization movements to resist falling in diverse slipping conditions.

A novel wearable apparatus for slipping perturbations (WASP) will deliver lifelike, unexpected slips in early, middle and late stance in younger (19 - 35 years of age) and older adults. Biomechanical analysis based on three-dimensional motion capture data of the reactive stabilization movements will generate novel results on the specificity and variability of protective stepping and arm swinging responses. The central hypothesis is that increases in specificity and decreases in variability of reactive stabilization movements will reduce fall rates. The long-term objective of this research is to support future studies into the repertoire of reactive stabilization movements across the full range of disturbances faced in navigating the environment.

Each participant will participate in 3 visits within the span of 1 week. On the initial visit, participants will perform informed consent, have demographic and body measurement information collected and complete medical and physical activity questionnaires. Upper and lower body strength will be measured using a hand-held dynamometer during the first and last visits. On each of the three visits, subjects will perform a gait variability assessment followed by a diverse slip perturbation assessment. Before recording data, retroreflective markers will be placed on specific anatomical locations. These locations are defined to create a full-body dynamics model. For gait variability assessment, participants will be familiarized with the activity, then they will walk on a treadmill for 5 minutes at a prescribed pace of 1.3 meters per second while whole body kinematics are collected. Both linear and nonlinear measures of gait variability will be calculated to determine possible relationships between these measures and other outcome variables such as learning rate for reactive movements and fall rate.

For diverse slip perturbation assessment, participants will walk overground back and forth across a large motion capture area. Previous studies show that walking speed is highly correlated with some outcome measures, specifically variations in whole body angular momentum, gait variability measures, and loss of balance following a slip. Therefore, gait speed will be controlled to 1.3 ± 0.2 m/s, a typically comfortable speed for both younger and older adults. Participants will be informed that a slip may occur, and that if slipped, they should attempt to maintain balance and continue walking. Participants will then be slipped without warning at a randomly chosen time after 1 to 3 minutes of walking. Slips will be administered to both feet simultaneously during early, middle or late stance in a randomized order. After each slip, participants will rest seated for 5 minutes. During this rest period, motion capture data and force data from the harness will be recorded, and the WASP will be reset for the next trial. Participants will complete four slips in each of early, middle, and late stance on each visit. Measures of falls, slip severity, and reactive stabilization movements will be calculated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68182
        • University of Nebraska-Omaha, Biomechanics Research Building

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 19-35 years for younger adults group, or age 65-79 years for older adults group.

Exclusion Criteria:

  • Uncontrolled hypertension
  • Peripheral arterial disease
  • Vertigo
  • Meniere's disease
  • Chronic dizziness
  • History of back or lower extremity injury
  • Surgery that affects the subject's mobility
  • Any neurological disease or impairment that affects limits the ability to walk, e.g. Stroke, Parkinson's disease, Multiple sclerosis

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Slipping Perturbations
Participants will be exposed to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase.
Other: Administered Slip Perturbations
Participants will be exposed to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fall Rates
Time Frame: Up to 7 days
Percentage of trials which result in a fall. Falls are classified when the maximum force on the load cell in the harness system exceeds 30% body weight.
Up to 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Heel Displacement of the Slipping Foot Following Slip Perturbation
Time Frame: Up to 7 days
The total displacement of the slipping foot from the point of administered slip perturbation, until the foot stops sliding is assessed.
Up to 7 days
Trunk Angular Momentum Following Slip Perturbation
Time Frame: Up to 7 days
Angular momentum of the trunk is assessed during the period of time from the onset of slip perturbation until the subject recovers or falls.
Up to 7 days
Position of the Recovery Step Following Slip Perturbation
Time Frame: Up to 7 days
Position of the placement of the swing foot relative to the center of mass in the transverse plane following slip perturbation will be assessed.
Up to 7 days
Coefficient of Variation of Stride Time Time Series
Time Frame: Up to 7 days
The coefficient of variation of the time series of stride times during treadmill walking is assessed.
Up to 7 days
Maximum Heel Sliding Velocity of the Slipping Foot Following Slip Perturbation
Time Frame: Up to 7 days
The maximum velocity of the slipping foot will be assessed within the period from the administered slip perturbation, until the foot stops sliding.
Up to 7 days
Time of the Recovery Step Following Slip Perturbation
Time Frame: Up to 7 days
Time of the placement of the swing foot relative to the onset of the administered slip perturbation is assessed
Up to 7 days
Sample Entropy of Stride Time Time Series
Time Frame: Up to 7 days
The sample entropy of the time series of stride times during treadmill walking is assessed.
Up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of General Medical Sciences (NIGMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathaniel H Hunt, PhD, University of Nebraska

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0877-18-EP
  • 2P20GM109090-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study will be registered at ClinicalTrials.gov prior to enrollment of the first subject. This will be completed by the PI. Research results will be made available in peer-reviewed publications, presentation at professional scientific conferences, uploaded to clinicaltrials.gov, and uploaded to the NCBI website, pubmed.gov. Informed consent documents will include a specific statement about posting clinical trial information at ClinicalTrials.gov. This will be complete by the PI. The University of Nebraska at Omaha makes every effort to adhere to the rules and recommendations regarding clinical trial registration and reporting.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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