Workplace Fall Prevention Through Slip Recovery Training

Sponsor
Virginia Polytechnic Institute and State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05740124
Collaborator
(none)
80
1
2
20
4

Study Details

Study Description

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.

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: slip recovery training
  • Behavioral: alternative balance training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Workplace Fall Prevention Through Slip Recovery Training
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Slip recovery training

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

Active Comparator: Alternative balance training

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
Participants practice standing and walking under varied sensory conditions.

Outcome Measures

Primary Outcome Measures

  1. evaluation of recruitment methods [2 years]

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

  2. evaluation of screening methods [2 years]

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

  3. worker adherence to slip recovery training [during 3 or 6 weeks of balance training]

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

  4. worker adherence to alternative balance training [during 3 or 6 weeks of balance training]

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

  5. worker retention during 12 weeks of falls tracking [during the12 weeks after completing the training intervention]

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

  6. lab-induced slip outcome (fall or recovery) [during the laboratory testing session that will take place within one week of completing training intervention]

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

  7. lab-induced slip distance [during the laboratory testing session that will take place within one week of completing training intervention]

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

  8. lab-induced slip peak slip speed [during the laboratory testing session that will take place within one week of completing training intervention]

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

  9. efficacy of field assessments of balance [during the field session one week after completing the training intervention]

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

Secondary Outcome Measures

  1. field assessment of slip distance [one week after intervention]

    the distance the slipping foot slides when exposed to a slip induced in the field

  2. field assessment of slip distance [12 weeks after intervention]

    the distance the slipping foot slides when exposed to a slip induced in the field

  3. field assessment of peak slip speed [one week after intervention]

    the maximum slipping speed of the foot during recovery from an induced slip

  4. field assessment of peak slip speed [12 weeks after intervention]

    the maximum slipping speed of the foot during recovery from an induced slip

  5. postural sway during quiet standing [one week after intervention]

    mean center of pressure speed

  6. postural sway during quiet standing [12 weeks after intervention]

    mean center of pressure speed

  7. dynamic balance performance [one week after intervention]

    maximum number of consecutive backward toe-to-heel steps completed while walking three times along a 3cm-wide, 3m-long beam on the floor without touching the ground

  8. dynamic balance performance [12 weeks after intervention]

    maximum number of consecutive backward toe-to-heel steps completed while walking three times along a 3cm-wide, 3m-long beam on the floor without touching the ground

  9. number of falls while working during 12-week follow up [during the 12 week follow up after intervention]

    determined using a daily text message questionnaire

  10. number of near-falls while working during 12-week follow up [during the 12 week follow up after intervention]

    determined using a daily text message questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • weigh over 250 pounds

  • answer 'no' to all questions of the Physical Activity Readiness Questionnaire

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Tech Blacksburg Virginia United States 24061

Sponsors and Collaborators

  • Virginia Polytechnic Institute and State University

Investigators

  • Principal Investigator: Michael L Madigan, PhD, Virginia Polytechnic Institute and State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Madigan, Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier:
NCT05740124
Other Study ID Numbers:
  • 22-853
First Posted:
Feb 22, 2023
Last Update Posted:
Feb 22, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Madigan, Professor, Virginia Polytechnic Institute and State University

Study Results

No Results Posted as of Feb 22, 2023