Effects of Task-Specific Step Training on Reactive Balance

Effects of Task-Specific Step Training on Reactive Balance After Laboratory-Induced Trips: A Pilot Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05734443

Enrollment

Registered

2023-02-21

Start date

2022-11-01

Completion date

2023-08-01

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Fall

Brief summary

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: * Does this step training regimen improve reactive balance after tripping compared to no training? * How well does this step training regimen improve reactive balance compared to treadmill training, which is a more commonly studied reactive balance training regimen that uses a specialized treadmill. Participants will: * complete step training or treadmill training (or no training if assigned to the control group) twice a week for three weeks * experience a laboratory-induced trip three weeks later to evaluate their reactive balance

Interventions

BEHAVIORALstep training

Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.

BEHAVIORALtreadmill 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* 65-80 years old * willing to use wearable sensors for 2-3 weeks (for a separate study) * no lower limb amputation * not weigh over 250 pounds * pass a telephone interview related to cognitive status

Exclusion criteria

* participants must pass a health screening involving a questionnaire that will be reviewed by a health care specialist. * participants must not have clinical osteoporosis as indicated by a bone mineral density of the lumbar vertebra and proximal femur of t\<-2.0 as obtained from dual energy x-ray absorptiometry (DEXA), or a DEXA scan completed within the last year.

Design outcomes

Primary

Measure	Time frame	Description
Trunk Angle at Touchdown of the First Recovery Step	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
Trip Outcome	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.

Secondary

Measure	Time frame	Description
Gait Speed	1 week after the 3-week intervention	The average forward speed of the participant prior to the laboratory-induced trip.
Recovery Step Length	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
Trip Recovery Strategy	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.
Average Step Speed	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.
Sacrum Height at Touchdown of the First Recovery Step	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	10
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.	10
Control Received no training.	10
Total	30

Baseline characteristics

Characteristic	Treadmill Training	Total	Step Training	Control
Age, Continuous	71.8 years STANDARD_DEVIATION 5.2	71.8 years STANDARD_DEVIATION 4.4	71.9 years STANDARD_DEVIATION 4.1	71.8 years STANDARD_DEVIATION 4.3
body height	1.69 meters STANDARD_DEVIATION 0.1	1.68 meters STANDARD_DEVIATION 0.1	1.63 meters STANDARD_DEVIATION 0.08	1.70 meters STANDARD_DEVIATION 0.12
body mass	79.6 kilograms STANDARD_DEVIATION 15.8	77.1 kilograms STANDARD_DEVIATION 16.8	69.9 kilograms STANDARD_DEVIATION 17	81.9 kilograms STANDARD_DEVIATION 16.8
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants	29 Participants	10 Participants	10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	10 Participants	29 Participants	9 Participants	10 Participants
Region of Enrollment United States	10 participants	30 participants	10 participants	10 participants
Sex: Female, Male Female	6 Participants	18 Participants	6 Participants	6 Participants
Sex: Female, Male Male	4 Participants	12 Participants	4 Participants	4 Participants
unipedal stance time (seconds)	16.5 seconds STANDARD_DEVIATION 12.7	17.6 seconds STANDARD_DEVIATION 12.3	18.9 seconds STANDARD_DEVIATION 11.5	17.3 seconds STANDARD_DEVIATION 13.8

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 10	0 / 10
other Total, other adverse events	0 / 10	0 / 10	0 / 10
serious Total, serious adverse events	0 / 10	0 / 10	0 / 10

Outcome results

Primary

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.