Effects of Task-Specific Step Training on Reactive Balance

NCT ID: NCT05734443

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-08-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

step training

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

treadmill training

Intervention Type: 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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

step training

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael L. Madigan, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Virginia Tech

Blacksburg, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

21-1072

Identifier Type: -

Identifier Source: org_study_id