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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05740124
Other study ID # 22-853
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 1, 2024

Study information

Verified date June 2023
Source Virginia Polytechnic Institute and State University
Contact Michael L Madigan, PhD
Phone (540) 231-3543
Email mlm@vt.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
slip recovery training
Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after slipping.
alternative balance training
Participants practice standing and walking under varied sensory conditions.

Locations

Country Name City State
United States Virginia Tech Blacksburg Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary evaluation of recruitment methods number of prospective participants who contact the investigators with interest in participating 2 years
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 field assessment of slip distance the distance the slipping foot slides when exposed to a slip induced in the field one week after intervention
Secondary field assessment of slip distance the distance the slipping foot slides when exposed to a slip induced in the field 12 weeks after intervention
Secondary field assessment of peak slip speed the maximum slipping speed of the foot during recovery from an induced slip one week after intervention
Secondary field assessment of peak slip speed the maximum slipping speed of the foot during recovery from an induced slip 12 weeks after intervention
Secondary postural sway during quiet standing mean center of pressure speed one week after intervention
Secondary postural sway during quiet standing mean center of pressure speed 12 weeks after intervention
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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