Accidental FallNCT07891637
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
A study testing Step Training, Treadmill Training and Otago Exercise Program in people with Accidental Fall, run by Virginia Polytechnic Institute and State University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall
- What is being tested?
- Step Training, Treadmill Training and Otago Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2027to Aug 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Neil Alexander, MD, 17347646831, nalexand@med.umich.edu
Virginia Tech
Blacksburg, Virginia, 24061
Michael Madigan, PhD, 15402316656, mlm@vt.edu
About this study
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?
Read more
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
- Being tested
- Step Training, Treadmill Training, Otago Exercise Program
- Keywords
- balance training, older adults, wearable sensors, fall prevention, exercise, step training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step TrainingBehavioural
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.
Treadmill TrainingBehavioural
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.
Otago Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Step Training | Experimental | Perturbation-based balance training without a treadmill Receives: Behavioral: Step Training |
| Treadmill Training | Experimental | Perturbation-based balance training with a treadmill Receives: Behavioral: Treadmill Training |
| Otago Exercise Program | Active comparator | Strength and standing balance training. Receives: Behavioral: Otago Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the end of intervention until 12 months later
Secondary outcomes (3)
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.
Measured: Before intervention, 1-week after intervention, and 6-months after intervention.
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.
Measured: Before intervention, 1-week after intervention, and 6-months after intervention.
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.
Measured: Before intervention, 1-week after intervention, and 6-months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Michael Madigan, Virginia Polytechnic Institute and State University
- Investigators
- Michael Madigan, PhD, Principal investigator, Virginia Polytechnic Institute and State UniversityNeil Alexander, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891637
- Sponsor's protocol ID
- 26-766
- Other IDs
- 1R01AG097954
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.