Effects of Task-Specific Step Training on Reactive Balance

NCT05734443 | Completed Results

• 1 other identifier: 21-1072
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Accidental Fall

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Recovery Step Length

  1 week after the 3-week intervention

• Sacrum Height at Touchdown of the First Recovery Step

  1 week after the 3-week intervention

• Gait Speed

  1 week after the 3-week intervention

• Average Step Speed

  1 week after the 3-week intervention

• Trip Recovery Strategy

  1 week after the 3-week intervention

Study Arms (3)

step training

EXPERIMENTAL

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

treadmill training

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

step training BEHAVIORAL

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

step training

treadmill training BEHAVIORAL

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.

treadmill training

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Virginia Tech

Blacksburg, Virginia, 24061, United States

Location

Results Point of Contact

• Title: Michael Madigan
• Organization: Virginia Tech

mlm@vt.edu

5402313543

Study Officials

• Michael L. Madigan, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 21, 2023
• Study Start: November 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)