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Slipping and FallsNCT03758040

Mechanisms of Fall Resistance to Diverse Slipping Conditions

A study testing Slips on Turns and Slips on Slopes in people with Slipping and Falls, 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

Falls are the leading source of injury for all ages, and for older adults are the primary cause of injury related death. Loss of foot to ground traction accounts for 25-40% of falls, typically referred to as a slip. Read more about this study

Who is it for?
Ages 19 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Slipping and Falls
What is being tested?
Slips on Turns and Slips on Slopes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited States
Study dates
15 Dec 2019to 16 Nov 2021
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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 19-35

Who cannot join

  • Uncontrolled hypertension
  • Peripheral arterial disease
  • Knee osteoarthritis
  • Vertigo
  • Meniere's disease
  • Chronic dizziness
Show all 9Show fewer
  • History of back or lower extremity injury
  • Surgery that affects mobility
  • Neurological disease that limits the ability to walk

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Biomechanics Research Building

    Omaha, Nebraska, 68182

Other trials in United States

About this study

Falls are the leading source of injury for all ages, and for older adults are the primary cause of injury related death. Loss of foot to ground traction accounts for 25-40% of falls, typically referred to as a slip. Slips alter the relationship between center of mass and lower limb base of support resulting in altered whole-body angular momentum and inability to support body weight due to loss of stability. But not all slips lead to falls. Stability may be recovered through a combination of response movements, such as swinging the arms or rapid recovery steps. Stability must be recovered quickly otherwise insufficient bodyweight support rapidly leads to a damaging ground collision. A high percentage of falls result in fractures, contusions and sprains to both the trunk and limbs, while slips disproportionately cause lower back injuries. A primary goal of fall prevention training is to improve the ability to resist slips using perturbations that mimic the specific sensory and biomechanical context of natural slip events. However, generating lifelike slip perturbations that mimic the diversity of slipping conditions poses a significant hurdle to improving a more general slip resistance ability. Using movement analysis, the investigators will determine the relationships between diverse slip conditions, reactive responses to slips from those conditions, and slip vulnerability across the gait cycle to generate new data that may guide future interventions.

Read the detailed description

Recent evidence suggests most slip-related falls in daily life happen in diverse slipping conditions where the ground is not level, or the person is turning or changing direction. While slips that occur during straight walking on level ground and the responses to those slips are relatively well understood, very little is known about slips that occur while walking on slopes or curved paths and which reactive responses are effective to prevent falls in such conditions. This limits the ability of clinicians to incorporate a diverse range of slipping experiences into fall prevention interventions. Understanding how reactive responses and slip vulnerability depend on diverse slip conditions may guide future interventions that promote a more general fall resistance to the broader range of slips encountered in the real environment.

This project will determine the impact of turns and slopes on reactive movements and fall vulnerability by determining the effects of path curvature on reactive movements and slip vulnerability at different times in the gait cycle and determining the effects of ground slope on reactive movements and slip vulnerability at difference times in the gait cycle. It is hypothesized that diverse slipping conditions will change the reactive responses involving protective stepping and arm swing and that the distinct dynamics of turns and slopes produce maximum vulnerability to slips at different times in the gait cycle compared to slips during straight walking on level ground. To evaluate these aims, the investigators will administer slip perturbations on slopes that vary in both magnitude and direction, on curved paths that vary in curvature, and with slip onset that varies across early, middle, and late stance. Understanding the relationships between diverse slipping conditions, reactive responses, slip severity and fall vulnerability may guide future research and training interventions towards more comprehensive fall resistance ability.

Being tested
Slips on Turns, Slips on Slopes

What participants receive

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

  • Slips on TurnsOther

    A slip will be administered to participants at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips will be delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters.

  • Slips on SlopesOther

    Slips will be administered to participants at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the Computer Assisted Rehabilitation Environment (CAREN) system treadmill.

Study groups in NCT03758040
Study groupRoleWhat they receive
Slips on TurnsExperimentalSlips will be administered during walking on a curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot.
Receives: Other: Slips on Turns
Slips on SlopesExperimentalSlips will be administered during walking on sloped ground of 5.0 or 10.0 degrees mediolaterally or anteroposteriorly, or flat ground, in early middle or late stance. For mediolateral slopes, slips will be administered to the uphill or downhill foot.
Receives: Other: Slips on Slopes

What is being measured

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

  1. Fall Rates - Slips on Turns

    Percentage of trials which result in a fall is recorded. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight.

    Measured: Up to 4 hours

  2. Fall Rates - Slips on Slopes

    Percentage of trials which result in a fall is recorded. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight.

    Measured: Up to 4 hours

Secondary outcomes (6)
  1. Slipping Foot Distance

    The distance travelled by the slipping foot relative to the center of mass following the administered slip perturbation

    Measured: Up to 4 hours

  2. Slipping Foot Maximum Velocity

    The maximum velocity of the slipping foot relative to the center of mass following the administered slip perturbation

    Measured: Up to 4 hours

  3. Trunk Maximum Angular Momentum

    The maximum angular momentum of the trunk following the administered slip perturbation

    Measured: Up to 4 hours

  4. Reactive Stepping Response Placement

    Position of the placement of the reactive stepping response relative to the center of mass following the administered slip perturbation

    Measured: Up to 4 hours

  5. Reactive Stepping Response Time

    Duration of time between the onset of the administered slip perturbation and the placement of the reactive stepping response

    Measured: Up to 4 hours

  6. Reactive Arm Swing Momentum Change

    The change in arm momentum between the onset of the administered slip perturbation and the end of the slip

    Measured: Up to 4 hours

Timeline

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

  1. First posted29 Nov 2018
  2. Study start15 Dec 2019
  3. Primary completion16 Nov 2021
  4. Study completion16 Nov 2021

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03758040
Sponsor's protocol ID
0861-18-EP
Other IDs
1R15AG063106
Status last verified
Apr 2025
First submitted
27 Nov 2018
Last updated
4 Jul 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Questions about this trial

What is this clinical trial studying?

A study testing Slips on Turns and Slips on Slopes in people with Slipping and Falls, 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 9 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 4 Jul 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 4 Jul 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 - Slips on Turns (time frame: Up to 4 hours). The study lists 2 primary outcomes in all. 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 4 Jul 2025.

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