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Not yet recruitingNCT07891637Updated Oct 23, 2026

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

An interventional study of Step Training and Treadmill Training in Accidental Fall, sponsored by Virginia Polytechnic Institute and State University. Not yet recruiting at 2 sites in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Prevention

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Accidental Fall

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Keywords

  • balance training
  • older adults
  • wearable sensors
  • fall prevention
  • exercise
  • step training
03

In context

Motor Activity

2,649 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.

This study's planned enrollment of 180 is above the median of 60 across 2,309 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 126 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Step Training

    Perturbation-based balance training without a treadmill

    Behavioral: Step Training

  • Experimental
    Treadmill Training

    Perturbation-based balance training with a treadmill

    Behavioral: Treadmill Training

  • Active comparator
    Otago Exercise Program

    Strength and standing balance training.

    Behavioral: Otago Exercise Program

Interventions

  • BehavioralStep Training

    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.

  • BehavioralTreadmill Training

    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.

  • BehavioralOtago Exercise Program

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.

  2. 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.

    Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.

  3. 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.

    Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.

  4. 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.

    Time frame: Before intervention, 1-week after intervention, 6-months after intervention.

  5. 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.

    Time frame: From the end of intervention until 12 months later.

  6. 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.

    Time frame: From the end of intervention until 12 months later

  7. 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.

    Time frame: From the end of intervention until 12 months later

Secondary outcomes

  1. Short Portable Performance Battery

    A standardized clinical mobility test involving gait speed, standing balance, and chair rises. This outcome measure will be obtained from the n=180 subjects across both sites at Virginia Tech and University of Michigan.

    Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.

  2. Berg Balance Scale

    A standardized clinical mobility test involving multiple balance components and an overall composite score that can predict falls. This outcome measure will be obtained from the n=180 subjects across both sites at Virginia Tech and University of Michigan.

    Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.

  3. Activities Balance Confidence Scale

    A standardized questionnaire that involves subjects rating their confidence to avoid falls while doing common activities. This outcome measure will be obtained from the n=180 subjects across both sites at Virginia Tech and University of Michigan.

    Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.

07

Study locations

2 sites
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Virginia Tech
    Blacksburg, Virginia 24061, United States
    • Michael Madigan, PhD · Contact · mlm@vt.edu · 15402316656
08

References and documents

Individual participant data

Plan to share: Yes — The data from balance testing pre-intervention, 1-week after intervention, and 6-months after intervention will include fall rate and body motion measurements in response to a laboratory-induced trip, and clinical mobility assessments. These will be saved as comma-delimited text files. During the 12-month follow up, voice recorder data will be obtained to count losses of balance, balance recoveries, falls, and contextual information of these events. These will be transcribed and saved as MS Word documents.

Supporting information: 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.

Data sharing details ↗ · data.lib.vt.edu

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07891637
Responsible party
Michael Madigan (Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Oct 23, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2030 (estimated)
Completion
Aug 2031 (estimated)
Last update
Oct 23, 2026

Study contacts

Michael Madigan, PhD
Contact
mlm@vt.edu
1-540-231-6656
Michael Madigan, PhD
principal investigator · Virginia Polytechnic Institute and State University
Neil Alexander, MD
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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