NCT05740124

Brief Summary

The goal of this clinical trial is to evaluate the feasibility of applying slip recovery training, a novel balance training exercise intervention, to workers who are at increased risk of slip-induced falls. This will be done via field studies with industrial partners. Note that the slip recovery training is not a device or drug. It is a detailed exercise regimen that aims to improve the the ability to recover balance after slipping. The main specific aims are are:

  • To investigate the feasibility of on-site slip recovery training
  • To validate field assessments for evaluating slip recovery training efficacy in subsequent research Participants will complete 3-6 once-weekly sessions of slip recovery training, answer daily text messages indicating any falls they experience while working over the 12 weeks after completing slip recovery training, and a subset of workers will be asked to participate in focus group discussions after the 12 weeks to provide information on the long-term feasibility of slip recovery training. A group of workers at Virginia Tech will also be asked to complete a laboratory session of testing during which they will be exposed to a laboratory-induced slip so that gold-standard measures of slip-induced fall recovery can be used to validate field assessments. Workers who complete slip recovery training will be compared to another group of workers who complete an alternative balance training that should improve balance but not improve slip recovery that is targeted by slip recovery training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

January 21, 2023

Last Update Submit

June 24, 2025

Conditions

Keywords

slipsbalance recoveryperturbation-based balance trainingbalance trainingfalls

Outcome Measures

Primary Outcomes (9)

  • evaluation of recruitment methods

    number of prospective participants who contact the investigators with interest in participating

    2 years

  • evaluation of screening methods

    percentage of prospective participants who are deemed a poor fit for the study based upon not passing the Physical Activity Readiness Questionnaire.

    2 years

  • worker adherence to slip recovery training

    average number of slip recovery training sessions completed across all participants assigned to slip recovery training

    during 3 or 6 weeks of balance training

  • worker adherence to alternative balance training

    average number of alternative balance training sessions completed across all participants assigned to alternative balance training

    during 3 or 6 weeks of balance training

  • worker retention during 12 weeks of falls tracking

    average number of weeks participants responded to text messages from investigators regarding slips and falls

    during the12 weeks after completing the training intervention

  • lab-induced slip outcome (fall or recovery)

    a binary measure determined based on the force applied to the safety harness worn by all participants when exposed to a laboratory-induced slip

    during the laboratory testing session that will take place within one week of completing training intervention

  • lab-induced slip distance

    the distance the slipping foot slides when exposed to a laboratory-induced slip

    during the laboratory testing session that will take place within one week of completing training intervention

  • lab-induced slip peak slip speed

    the peak speed of the slipping foot during slip when exposed to a laboratory-induced slip

    during the laboratory testing session that will take place within one week of completing training intervention

  • efficacy of field assessments of balance

    Pearson product correlation coefficient between field assessment of slip distance and lab-induced slip distance

    during the field session one week after completing the training intervention

Secondary Outcomes (10)

  • field assessment of slip distance

    one week after intervention

  • field assessment of slip distance

    12 weeks after intervention

  • field assessment of peak slip speed

    one week after intervention

  • field assessment of peak slip speed

    12 weeks after intervention

  • postural sway during quiet standing

    one week after intervention

  • +5 more secondary outcomes

Study Arms (2)

Slip recovery training

EXPERIMENTAL

Once weekly sessions of slip recovery training for 3 or 6 weeks. Each session will be 20 minutes of training. Training will involve volitional and reactive stepping movements that mimic the movements necessary to recover balance after slipping while walking.

Behavioral: slip recovery training

Alternative balance training

ACTIVE COMPARATOR

Once weekly sessions of balance training for 3 or 6 weeks. Each session will be 20 minutes of training. Training will involve standing balance under varied sensory conditions, and tandem walking forward and backward under varied sensory conditions.

Behavioral: alternative balance training

Interventions

Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after slipping.

Slip recovery training

Participants practice standing and walking under varied sensory conditions.

Alternative balance training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Virginia Tech workers in Dining Services, Facilities and Housekeeping, and construction.
  • Veolia field workers in water distribution and water main construction
  • age 18-65 years old
  • willing to complete 3 or 6 training sessions, lab testing session, and daily falls tracking for 12 weeks

You may not qualify if:

  • weigh over 250 pounds
  • answer 'no' to all questions of the Physical Activity Readiness Questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Tech

Blacksburg, Virginia, 24061, United States

Location

Study Officials

  • Michael L Madigan, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: We selected N/A for study phase because this study involves a behavioral intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2023

First Posted

February 22, 2023

Study Start

June 1, 2023

Primary Completion

December 15, 2024

Study Completion

March 31, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations