Trial Outcomes & Findings for Effects of Task-Specific Step Training on Reactive Balance (NCT NCT05734443)

NCT ID: NCT05734443

Last Updated: 2025-09-24

Results Overview

After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 1 week after the 3-week intervention
• Results posted on: 2025-09-24

Participant Flow

Participant milestones

Measure	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 volitional and reactive stepping movements that mimic the movements necessary to recover balance after tripping while walking. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.	Treadmill 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. treadmill training: 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.	Control Received no training.
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Task-Specific Step Training on Reactive Balance

Baseline characteristics by cohort

Measure	Step Training n=10 Participants 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. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.	Treadmill Training n=10 Participants 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. treadmill training: 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.	Control n=10 Participants Received no training.	Total n=30 Participants Total of all reporting groups
Age, Continuous	71.9 years STANDARD_DEVIATION 4.1 • n=5 Participants	71.8 years STANDARD_DEVIATION 5.2 • n=7 Participants	71.8 years STANDARD_DEVIATION 4.3 • n=5 Participants	71.8 years STANDARD_DEVIATION 4.4 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	30 participants n=4 Participants
body height	1.63 meters STANDARD_DEVIATION 0.08 • n=5 Participants	1.69 meters STANDARD_DEVIATION 0.10 • n=7 Participants	1.70 meters STANDARD_DEVIATION 0.12 • n=5 Participants	1.68 meters STANDARD_DEVIATION 0.10 • n=4 Participants
body mass	69.9 kilograms STANDARD_DEVIATION 17.0 • n=5 Participants	79.6 kilograms STANDARD_DEVIATION 15.8 • n=7 Participants	81.9 kilograms STANDARD_DEVIATION 16.8 • n=5 Participants	77.1 kilograms STANDARD_DEVIATION 16.8 • n=4 Participants
unipedal stance time (seconds)	18.9 seconds STANDARD_DEVIATION 11.5 • n=5 Participants	16.5 seconds STANDARD_DEVIATION 12.7 • n=7 Participants	17.3 seconds STANDARD_DEVIATION 13.8 • n=5 Participants	17.6 seconds STANDARD_DEVIATION 12.3 • n=4 Participants

PRIMARY outcome

Timeframe: 1 week after the 3-week intervention

After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers

Outcome measures

Measure	Step Training n=10 trips 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. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.	Treadmill Training n=10 trips 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. treadmill training: 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.	Control n=10 trips Received no training.
Trunk Angle at Touchdown of the First Recovery Step	27.0 degrees Standard Deviation 8.2	24.6 degrees Standard Deviation 7.4	28.4 degrees Standard Deviation 6.9

PRIMARY outcome

Timeframe: 1 week after the 3-week intervention

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.

Outcome measures

Measure	Step Training n=10 trips 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. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.	Treadmill Training n=10 trips 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. treadmill training: 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.	Control n=10 trips Received no training.
Trip Outcome	4 number of falls	10 number of falls	8 number of falls

SECONDARY outcome

Timeframe: 1 week after the 3-week intervention

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

Outcome measures

Measure	Step Training n=10 trips 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. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.	Treadmill Training n=10 trips 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. treadmill training: 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.	Control n=10 trips Received no training.
Recovery Step Length	49.5 % body height Standard Deviation 9.9	45.4 % body height Standard Deviation 5.2	40.1 % body height Standard Deviation 6.2

SECONDARY outcome

Timeframe: 1 week after the 3-week intervention

After a laboratory-induced trip, the minimum distance between the walkway and the greater trochanter marker on the non-tripping limb during trip recovery.

Outcome measures

Measure	Step Training n=10 trips 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. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.	Treadmill Training n=10 trips 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. treadmill training: 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.	Control n=10 trips Received no training.
Sacrum Height at Touchdown of the First Recovery Step	97.4 % of sacrum height while standing Standard Deviation 7.3	96.7 % of sacrum height while standing Standard Deviation 10.1	97.7 % of sacrum height while standing Standard Deviation 13.0

SECONDARY outcome

Timeframe: 1 week after the 3-week intervention

The average forward speed of the participant prior to the laboratory-induced trip.

Outcome measures

Measure	Step Training n=10 trips 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. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.	Treadmill Training n=10 trips 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. treadmill training: 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.	Control n=10 trips Received no training.
Gait Speed	1.6 meters per second Standard Deviation 0.2	1.5 meters per second Standard Deviation 0.2	1.5 meters per second Standard Deviation 0.2

SECONDARY outcome

Timeframe: 1 week after the 3-week intervention

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.

Outcome measures

Measure	Step Training n=10 trips 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. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.	Treadmill Training n=10 trips 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. treadmill training: 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.	Control n=10 trips Received no training.
Average Step Speed	1.7 meters per second Standard Deviation 0.4	1.6 meters per second Standard Deviation 0.2	1.4 meters per second Standard Deviation 0.3

SECONDARY outcome

Timeframe: 1 week after the 3-week intervention

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.

Outcome measures

Measure	Step Training n=10 Participants 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. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.	Treadmill Training n=10 Participants 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. treadmill training: 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.	Control n=10 trips Received no training.
Trip Recovery Strategy	12 number of trips using lowering strategy	12 number of trips using lowering strategy	13 number of trips using lowering strategy

Adverse Events

Step Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treadmill Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Madigan

Virginia Tech

Phone: 5402313543

Email: mlm@vt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place