An interventional study of step training and treadmill training in Accidental Fall, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to evaluate a novel and pragmatic (i.e., not requiring specialized equipment) task-specific step training regimen that aims to improve reactive balance after tripping. The main questions it aims to answer are:
Participants will:
Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated volitional and reactive stepping movements that mimic the movements necessary to recover balance after tripping while walking.
Behavioral: step training
Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated exposure to simulated trips on a treadmill. To simulate a trip, participants first stand on the stationary treadmill belt. A sudden and unexpected increase in backward treadmill belt speed induces a forward loss of balance similar to when tripping. Participants are then required to take steps to recover balance and establish a stable gait pattern before the trial ends. Trials are repeated using pseudo-random speeds that provide variability and are individualized to each participant's capabilities.
Behavioral: treadmill training
Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.
Sudden treadmill changes in speed (from standing) induce trip-like losses of balance, after which participants take steps to recover balance and establish a stable gait pattern. This is repeated over a range of speeds to both provide training variability and to individualize training to each participant's capability.
Trunk Angle at Touchdown of the First Recovery Step
After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers
Time frame: 1 week after the 3-week intervention
Trip Outcome
This is a binary variable that has a value of either "fall" or "recovery." After a laboratory-induced trip, trip outcome will be assign to one of the following two values: "fall" if a participant is fully and continuously supported by the harness as observed from video, or if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is greater than 40% of body weight \* seconds. The harness force will be measured by a uniaxial load cell. "recovery" if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is less than 40% of body weight \* seconds. The harness force will be measured by a uniaxial load cell.
Time frame: 1 week after the 3-week intervention
Recovery Step Length
After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown
Time frame: 1 week after the 3-week intervention
Sacrum Height at Touchdown of the First Recovery Step
After a laboratory-induced trip, the minimum distance between the walkway and the greater trochanter marker on the non-tripping limb during trip recovery.
Time frame: 1 week after the 3-week intervention
Gait Speed
The average forward speed of the participant prior to the laboratory-induced trip.
Time frame: 1 week after the 3-week intervention
Average Step Speed
After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown divided by the time from impact with the trip obstacle and touchdown of the initial recovery step.
Time frame: 1 week after the 3-week intervention
Trip Recovery Strategy
This is a binary variable that has a value of either "elevating" or "lowering." Elevating or lowering, depending upon how the participant uses the foot that trips on the obstacle after the laboratory-induced trip. If the foot is elevated over the obstacle, then this will be elevating. If the foot is lowered to the ground and the opposite foot first steps over the obstacle, then this will be lowering. The measurement tool to determine this outcome is a video recording of the trip, and this outcome has no units.
Time frame: 1 week after the 3-week intervention
| Milestone | Step Training | Treadmill Training | Control |
|---|---|---|---|
| Started | 10 | 10 | 10 |
| Completed | 10 | 10 | 10 |
| Not completed | 0 | 0 | 0 |
After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers
| degrees | Step Training | Treadmill Training | Control |
|---|---|---|---|
| Trunk Angle at Touchdown of the First Recovery Step | 27.0 ± 8.2 | 24.6 ± 7.4 | 28.4 ± 6.9 |
This is a binary variable that has a value of either "fall" or "recovery." After a laboratory-induced trip, trip outcome will be assign to one of the following two values: "fall" if a participant is fully and continuously supported by the harness as observed from video, or if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is greater than 40% of body weight \* seconds. The harness force will be measured by a uniaxial load cell. "recovery" if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is less than 40% of body weight \* seconds. The harness force will be measured by a uniaxial load cell.
| number of falls | Step Training | Treadmill Training | Control |
|---|---|---|---|
| Trip Outcome | 4 | 10 | 8 |
After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown
| % body height | Step Training | Treadmill Training | Control |
|---|---|---|---|
| Recovery Step Length | 49.5 ± 9.9 | 45.4 ± 5.2 | 40.1 ± 6.2 |
After a laboratory-induced trip, the minimum distance between the walkway and the greater trochanter marker on the non-tripping limb during trip recovery.
| % of sacrum height while standing | Step Training | Treadmill Training | Control |
|---|---|---|---|
| Sacrum Height at Touchdown of the First Recovery Step | 97.4 ± 7.3 | 96.7 ± 10.1 | 97.7 ± 13.0 |
The average forward speed of the participant prior to the laboratory-induced trip.
| meters per second | Step Training | Treadmill Training | Control |
|---|---|---|---|
| Gait Speed | 1.6 ± 0.2 | 1.5 ± 0.2 | 1.5 ± 0.2 |
After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown divided by the time from impact with the trip obstacle and touchdown of the initial recovery step.
| meters per second | Step Training | Treadmill Training | Control |
|---|---|---|---|
| Average Step Speed | 1.7 ± 0.4 | 1.6 ± 0.2 | 1.4 ± 0.3 |
This is a binary variable that has a value of either "elevating" or "lowering." Elevating or lowering, depending upon how the participant uses the foot that trips on the obstacle after the laboratory-induced trip. If the foot is elevated over the obstacle, then this will be elevating. If the foot is lowered to the ground and the opposite foot first steps over the obstacle, then this will be lowering. The measurement tool to determine this outcome is a video recording of the trip, and this outcome has no units.
| number of trips using lowering strategy | Step Training | Treadmill Training | Control |
|---|---|---|---|
| Trip Recovery Strategy | 12 | 12 | 13 |
Collected over 1 week after the 3-week intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Step Training | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Treadmill Training | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Control | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Step Training | Treadmill Training | Control | Total |
|---|---|---|---|---|
| Mean | 71.9 ± 4.1 | 71.8 ± 5.2 | 71.8 ± 4.3 | 71.8 ± 4.4 |
| Sex: Female, Male(Participants) | Step Training | Treadmill Training | Control | Total |
|---|---|---|---|---|
| Female | 6 | 6 | 6 | 18 |
| Male | 4 | 4 | 4 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Step Training | Treadmill Training | Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 10 | 9 | 10 | 29 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Step Training | Treadmill Training | Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 9 | 10 | 10 | 29 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Step Training | Treadmill Training | Control | Total |
|---|---|---|---|---|
| United States | 10 | 10 | 10 | 30 |
| body height(meters) | Step Training | Treadmill Training | Control | Total |
|---|---|---|---|---|
| Mean | 1.63 ± 0.08 | 1.69 ± 0.10 | 1.70 ± 0.12 | 1.68 ± 0.10 |
| body mass(kilograms) | Step Training | Treadmill Training | Control | Total |
|---|---|---|---|---|
| Mean | 69.9 ± 17.0 | 79.6 ± 15.8 | 81.9 ± 16.8 | 77.1 ± 16.8 |
| unipedal stance time (seconds)(seconds) | Step Training | Treadmill Training | Control | Total |
|---|---|---|---|---|
| Mean | 18.9 ± 11.5 | 16.5 ± 12.7 | 17.3 ± 13.8 | 17.6 ± 12.3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Virginia Polytechnic Institute and State University