Clinical trial NCT05740124: Workplace Fall Prevention Through Slip Recovery Training
Official title: Workplace Fall Prevention Through Slip Recovery Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Accidental Fall
Keywords: slips
balance recovery
perturbation-based balance training
balance training
falls
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We selected N/A for study phase because this study involves a behavioral intervention.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: evaluation of recruitment methods
timeFrame: 2 years
measure: evaluation of screening methods
timeFrame: 2 years
measure: worker adherence to slip recovery training
timeFrame: during 3 or 6 weeks of balance training
measure: worker adherence to alternative balance training
timeFrame: during 3 or 6 weeks of balance training
measure: worker retention during 12 weeks of falls tracking
timeFrame: during the12 weeks after completing the training intervention
measure: lab-induced slip outcome (fall or recovery)
timeFrame: during the laboratory testing session that will take place within one week of completing training intervention
measure: lab-induced slip distance
timeFrame: during the laboratory testing session that will take place within one week of completing training intervention
measure: lab-induced slip peak slip speed
timeFrame: during the laboratory testing session that will take place within one week of completing training intervention
measure: efficacy of field assessments of balance
timeFrame: during the field session one week after completing the training intervention
Secondary outcomes:
measure: field assessment of slip distance
timeFrame: one week after intervention
measure: field assessment of slip distance
timeFrame: 12 weeks after intervention
measure: field assessment of peak slip speed
timeFrame: one week after intervention
measure: field assessment of peak slip speed
timeFrame: 12 weeks after intervention
measure: postural sway during quiet standing
timeFrame: one week after intervention
measure: postural sway during quiet standing
timeFrame: 12 weeks after intervention
measure: dynamic balance performance
timeFrame: one week after intervention
measure: dynamic balance performance
timeFrame: 12 weeks after intervention
measure: number of falls while working during 12-week follow up
timeFrame: during the 12 week follow up after intervention
measure: number of near-falls while working during 12-week follow up
timeFrame: during the 12 week follow up after intervention
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Tech
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Michael L Madigan, PhD
role: PRINCIPAL_INVESTIGATOR
References: