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
- Are there results?
- Not yet: the study is under way
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
Show all 10Show fewer
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07891637
- Acronym / sponsor ID
- 26-766
- Conditions
- Accidental Fall
- Keywords
- balance training, older adults, wearable sensors, fall prevention, exercise, step training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, National Institute on Aging (NIA)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Step Training | Experimental | Behavioral: Step TrainingPerturbation-based balance training without a treadmill |
| Treadmill Training | Experimental | Behavioral: Treadmill TrainingPerturbation-based balance training with a treadmill |
| Otago Exercise Program | Active comparator | Behavioral: Otago Exercise ProgramStrength and standing balance training. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step TrainingPerturbation-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. | Behavioural | Step Training |
| Treadmill TrainingPerturbation-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. | Behavioural | Treadmill Training |
| Otago Exercise ProgramStrength 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. | Behavioural | Otago Exercise Program |
Primary outcome
Trunk angle during balance recovery after lab-induced trip
Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.
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.
Recovery step length after lab-induced trip
Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.
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.
Recovery step speed after lab-induced trip
Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.
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.
Fall rate after lab-induced trip
Time frame: Before intervention, 1-week after intervention, 6-months after intervention.
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.
Number of real-world losses of balance during 12-month follow up
Time frame: From the end of intervention until 12 months later.
This outcome measure will be obtained from the n=180 subjects across both sites at Virginia Tech and University of Michigan.
Number of real-world balance recoveries during 12-month follow up
Time frame: From the end of intervention until 12 months later
This outcome measure will be obtained from the n=180 subjects across both sites at Virginia Tech and University of Michigan.
Number of real-world falls during 12-month follow up
Time frame: From the end of intervention until 12 months later
This outcome measure will be obtained from the n=180 subjects across both sites at Virginia Tech and University of Michigan.
3 secondary outcomes
Short Portable Performance Battery
Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.
Berg Balance Scale
Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.
Activities Balance Confidence Scale
Time frame: Before intervention, 1-week after intervention, and 6-months after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Madigan, PhD principal investigator
Virginia Polytechnic Institute and State University
Neil Alexander, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Madigan, PhD (1-540-231-6656, mlm@vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk angle during balance recovery after lab-induced trip (time frame: Before intervention, 1-week after intervention, and 6-months after intervention.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.