NCT03755336

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

4.1 years

First QC Date

November 21, 2018

Results QC Date

March 17, 2025

Last Update Submit

May 7, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    Up to 7 days

Secondary Outcomes (7)

  • Total Heel Displacement of the Slipping Foot Following Slip Perturbation

    Up to 7 days

  • Trunk Angular Momentum Following Slip Perturbation

    Up to 7 days

  • Position of the Recovery Step Following Slip Perturbation

    Up to 7 days

  • Coefficient of Variation of Stride Time Time Series

    Up to 7 days

  • Maximum Heel Sliding Velocity of the Slipping Foot Following Slip Perturbation

    Up to 7 days

  • +2 more secondary outcomes

Study Arms (1)

Slipping Perturbations

EXPERIMENTAL

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

Interventions

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.

Slipping Perturbations

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Omaha, Biomechanics Research Building

Omaha, Nebraska, 68182, United States

Location

Limitations and Caveats

Fall rates were derived from controlled walking trials using a safety harness on a sliding gantry. The harness may have influenced natural recovery responses. Additionally, laboratory conditions and participants' awareness of slip risk could have induced anticipatory behaviors, limiting generalizability.

Results Point of Contact

Title
Nathaniel Hunt
Organization
University of Nebraska Omaha

Study Officials

  • Nathaniel H Hunt, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 27, 2018

Study Start

December 1, 2019

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

May 25, 2025

Results First Posted

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations