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

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

Study Overview

• Status: Completed
• Conditions: Accidental Fall
• Intervention / Treatment: Behavioral: step training; Behavioral: treadmill training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Blacksburg, Virginia, United States, 24061
      • Virginia Tech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 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.	Behavioral: step training; Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1 week after the 3-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1 week after the 3-week intervention
Gait Speed	The average forward speed of the participant prior to the laboratory-induced trip.	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.	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.	1 week after the 3-week intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	during the week after the 3-weeks of intervention

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Michael L. Madigan, PhD, Virginia Polytechnic Institute and State University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Contraceptive Agents, Hormonal; Antineoplastic Agents; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Luteolytic Agents; Contraceptive Agents, Female; Contraceptive Agents; Triptorelin Pamoate
• Other Study ID Numbers: 21-1072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No