Accidental Fall Clinical Trial
Official title:
Workplace Fall Prevention Through Slip Recovery Training
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Tech | Blacksburg | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Polytechnic Institute and State University |
United States,
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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