Workplace Fall Prevention Through Slip Recovery Training

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.

Study Overview

• Status: Recruiting
• Conditions: Accidental Fall
• Intervention / Treatment: Behavioral: slip recovery training; Behavioral: alternative balance training

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael L Madigan, PhD; Phone Number: (540) 231-3543; Email: mlm@vt.edu

Study Locations

• United States
  • Virginia
    • Blacksburg, Virginia, United States, 24061
      • Recruiting
      • Virginia Tech
      • Contact: Michael L Madigan, PhD; Phone Number: 540-231-3543; Email: mlm@vt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
field assessment of slip distance	the distance the slipping foot slides when exposed to a slip induced in the field	one week after intervention
field assessment of slip distance	the distance the slipping foot slides when exposed to a slip induced in the field	12 weeks after intervention
field assessment of peak slip speed	the maximum slipping speed of the foot during recovery from an induced slip	one week after intervention
field assessment of peak slip speed	the maximum slipping speed of the foot during recovery from an induced slip	12 weeks after intervention
postural sway during quiet standing	mean center of pressure speed	one week after intervention
postural sway during quiet standing	mean center of pressure speed	12 weeks after intervention
dynamic balance performance	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	one week after intervention
dynamic balance performance	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	12 weeks after intervention
number of falls while working during 12-week follow up	determined using a daily text message questionnaire	during the 12 week follow up after intervention
number of near-falls while working during 12-week follow up	determined using a daily text message questionnaire	during the 12 week follow up after intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: falls; balance training; perturbation-based balance training; slips; balance recovery
• Other Study ID Numbers: 22-853

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No