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Slip PerturbationsNCT03755336

Variability and Specificity in Reactive Stabilization Movements to Diverse Slip Perturbations

A study testing Administered Slip Perturbations in people with Slip Perturbations, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Slip Perturbations
What is being tested?
Administered Slip Perturbations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
1 Dec 2019to 1 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska-Omaha, Biomechanics Research Building

    Omaha, Nebraska, 68182

Other trials in United States

About this study

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.

Read the 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.

Being tested
Administered Slip Perturbations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administered Slip PerturbationsOther

    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.

Study groups in NCT03755336
Study groupRoleWhat they receive
Slipping PerturbationsExperimentalParticipants 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.
Receives: Other: Administered Slip Perturbations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fall Rates

    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.

    Measured: Up to 7 days

Secondary outcomes (7)
  1. Total Heel Displacement of the Slipping Foot Following Slip Perturbation

    The total displacement of the slipping foot from the point of administered slip perturbation, until the foot stops sliding is assessed.

    Measured: Up to 7 days

  2. Trunk Angular Momentum Following Slip Perturbation

    Angular momentum of the trunk is assessed during the period of time from the onset of slip perturbation until the subject recovers or falls.

    Measured: Up to 7 days

  3. Position of the Recovery Step Following Slip Perturbation

    Position of the placement of the swing foot relative to the center of mass in the transverse plane following slip perturbation will be assessed.

    Measured: Up to 7 days

  4. Coefficient of Variation of Stride Time Time Series

    The coefficient of variation of the time series of stride times during treadmill walking is assessed.

    Measured: Up to 7 days

  5. Maximum Heel Sliding Velocity of the Slipping Foot Following Slip Perturbation

    The maximum velocity of the slipping foot will be assessed within the period from the administered slip perturbation, until the foot stops sliding.

    Measured: Up to 7 days

  6. Time of the Recovery Step Following Slip Perturbation

    Time of the placement of the swing foot relative to the onset of the administered slip perturbation is assessed

    Measured: Up to 7 days

  7. Sample Entropy of Stride Time Time Series

    The sample entropy of the time series of stride times during treadmill walking is assessed.

    Measured: Up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start1 Dec 2019
  3. Primary completion1 Jan 2024
  4. Study completion1 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03755336
Sponsor's protocol ID
0877-18-EP
Other IDs
2P20GM109090-06
Status last verified
May 2025
First submitted
21 Nov 2018
Last updated
25 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Administered Slip Perturbations in people with Slip Perturbations, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fall Rates (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.

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