Effects of a Novel Perturbation Balance Training Program on Laboratory and Real-World Trip-Induced Losses of Balance and Falls Among Balance-Impaired Older Adults

NCT07891637 | Not Yet Recruiting

• 2 other identifiers: 26-7661R01AG097954
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if a novel balance training stepping exercise can reduce the risk of falling among adults over the age of 65. The main question it aims to answer is:

• Does the novel stepping exercise improve laboratory-based measurements of balance and fall rate?
• Does the novel stepping exercise improve real-world measurements of balance and fall rate? Researchers will compare the novel stepping exercise to 1) a more established stepping exercise that requires more expensive equipment, and 2) a more established general exercise program focusing on strength and standing balance without stepping. Participants will:
• complete their assigned exercise intervention twice a week for three weeks, then complete booster sessions of their assigned exercise intervention once a month during months 1-5 after completing the initial three weeks of intervention
• complete laboratory sessions to test their balance: a) before intervention, b) 1 week after intervention, and c) 6 months after intervention
• use a wearable sensor daily for 12 months after intervention to capture any loss of balance or fall events

Conditions

Accidental Fall

Keywords

balance training; older adults; wearable sensors; fall prevention; exercise; step training

Outcome Measures

Primary Outcomes (7)

• Trunk angle during balance recovery after lab-induced trip

  Angle from vertical to a line connecting midpoint of greater trochanter markers and midpoint of acromion markers, measured at the instant of touchdown of the first step over the trip obstacle. This outcome measure will only be obtained from the n=60 subjects at Virginia Tech.

  Before intervention, 1-week after intervention, and 6-months after intervention.

• Recovery step length after lab-induced trip

  The distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping limb after the first step over the tripping obstacle. This outcome measure will only be obtained from the n=60 subjects at Virginia Tech.

  Before intervention, 1-week after intervention, and 6-months after intervention.

• Recovery step speed after lab-induced trip

  Step length divided by step time. Step length is the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping limb after the first step over the tripping obstacle. Step time is the time from the foot first contacting the trip obstacle and the first step over the trip obstacle contacting the floor. This outcome measure will only be obtained from the n=60 subjects at Virginia Tech.

  Before intervention, 1-week after intervention, and 6-months after intervention.

• Fall rate after lab-induced trip

  Number of falls into a safety harness divided by the total number of trips. This outcome measure will only be obtained from the n=60 subjects at Virginia Tech.

  Before intervention, 1-week after intervention, 6-months after intervention.

• Number of real-world losses of balance during 12-month follow up

  This outcome measure will be obtained from the n=180 subjects across both sites at Virginia Tech and University of Michigan.

  From the end of intervention until 12 months later.

• Number of real-world balance recoveries during 12-month follow up

  This outcome measure will be obtained from the n=180 subjects across both sites at Virginia Tech and University of Michigan.

  From the end of intervention until 12 months later

• Number of real-world falls during 12-month follow up

  This outcome measure will be obtained from the n=180 subjects across both sites at Virginia Tech and University of Michigan.

  From the end of intervention until 12 months later

Secondary Outcomes (3)

• Short Portable Performance Battery

  Before intervention, 1-week after intervention, and 6-months after intervention.

• Berg Balance Scale

  Before intervention, 1-week after intervention, and 6-months after intervention.

• Activities Balance Confidence Scale

  Before intervention, 1-week after intervention, and 6-months after intervention.

Study Arms (3)

Step Training

EXPERIMENTAL

Perturbation-based balance training without a treadmill

Behavioral: Step Training

Treadmill Training

EXPERIMENTAL

Perturbation-based balance training with a treadmill

Behavioral: Treadmill Training

Otago Exercise Program

ACTIVE COMPARATOR

Strength and standing balance training.

Behavioral: Otago Exercise Program

Interventions

Step Training BEHAVIORAL

Perturbation-based balance training without a treadmill. Initial dosage will be twice a week for three weeks. Then booster sessions will be completed once a month during months 1-5 after completing the initial three weeks of intervention.

Step Training

Treadmill Training BEHAVIORAL

Perturbation-based balance training with a treadmill. Initial dosage will be twice a week for three weeks. Then booster sessions will be completed once a month during months 1-5 after completing the initial three weeks of intervention.

Treadmill Training

Otago Exercise Program BEHAVIORAL

Strength and standing balance training without stepping. Initial dosage will be twice a week for three weeks. Then booster sessions will be completed once a month during months 1-5 after completing the initial three weeks of intervention.

Otago Exercise Program

Eligibility Criteria

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

You may qualify if:

• Age ≥ 65 years
• Moderate balance impairment as indicated by best unipedal stance time \<10 seconds
• Able to ambulate household distances and tolerate testing and training without an assistive device
• No significant cognitive impairment (telephone Montreal Cognitive Assessment \>18)
• Functional vision and hearing (with correction if needed)
• Comprehension of written and spoken English
• Willing and able to study-required voice recorders
• Limited physical activity (\<150 min/week moderate-vigorous), not in physical therapy, not presently in balance training programs (such as Tai Chi training).
• Not having acute or chronic conditions which would significantly alter study participation and markedly bias the results: active or symptomatic cardiopulmonary conditions; active or unstable metabolic conditions such as labile glycemic control; alcohol intake \>3 oz/day; hemiplegia or lower limb amputation; acute medical conditions, such as acute flare-up of joint condition or infection; significant orthopedic or musculoskeletal condition that does not allow weight bearing.
• Osteoporosis screening (only for subjects exposed to lab-induced trip): bone mineral density t-score \> -2.5 and no history of fragility fracture of the hip, spine, or wrist.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• University of Michigan: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Virginia Tech

Blacksburg, Virginia, 24061, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Michael Madigan, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

• Neil Alexander, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Madigan, PhD

CONTACT

1-540-231-6656; mlm@vt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available at the completion of the study (8/31/2031) or later if a grant extension is used.
• Access Criteria: Researchers interested in these data will be able to access these data and information. They will be posted on the Virginia Tech Data Repository.

Locations

US (2)