Accidental FallNCT05734443
Effects of Task-Specific Step Training on Reactive Balance
A study testing step training and treadmill training in people with Accidental Fall, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall
- What is being tested?
- step training and treadmill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Task-Specific Step Training on Reactive Balance After Laboratory-Induced Trips: A Pilot Trial
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.
Read more
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
- Being tested
- step training, treadmill training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
step trainingBehavioural
Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.
treadmill trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| step training | Experimental | 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. Receives: Behavioral: step training |
| treadmill training | Experimental | 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. Receives: Behavioral: treadmill training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Angle at Touchdown of the First Recovery Step
After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers
Measured: 1 week after the 3-week intervention
Trip Outcome
This is a binary variable that has a value of either "fall" or "recovery."
After a laboratory-induced trip, trip outcome will be assign to one of the following two values:
"fall" if a participant is fully and continuously supported by the harness as observed from video, or if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is greater than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell.
"recovery" if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is less than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell.
Measured: 1 week after the 3-week intervention
Secondary outcomes (5)
Recovery Step Length
After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown
Measured: 1 week after the 3-week intervention
Sacrum Height at Touchdown of the First Recovery Step
After a laboratory-induced trip, the minimum distance between the walkway and the greater trochanter marker on the non-tripping limb during trip recovery.
Measured: 1 week after the 3-week intervention
Gait Speed
The average forward speed of the participant prior to the laboratory-induced trip.
Measured: 1 week after the 3-week intervention
Average Step Speed
After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown divided by the time from impact with the trip obstacle and touchdown of the initial recovery step.
Measured: 1 week after the 3-week intervention
Trip Recovery Strategy
This is a binary variable that has a value of either "elevating" or "lowering."
Elevating or lowering, depending upon how the participant uses the foot that trips on the obstacle after the laboratory-induced trip. If the foot is elevated over the obstacle, then this will be elevating. If the foot is lowered to the ground and the opposite foot first steps over the obstacle, then this will be lowering. The measurement tool to determine this outcome is a video recording of the trip, and this outcome has no units.
Measured: 1 week after the 3-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Nov 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael L. Madigan, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734443
- Sponsor's protocol ID
- 21-1072
- Status last verified
- Sep 2023
- First submitted
- 8 Feb 2023
- Last updated
- 24 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee Y, Alexander NB, Franck CT, Castleberry J, Madigan ML. A pilot trial investigating feasibility and preliminary efficacy of a task-specific step training regimen to improve balance recovery among community-dwelling older adults. PLoS One. 2026 Jul 31;21(7):e0354677. doi: 10.1371/journal.pone.0354677. eCollection 2026.
PubMed 42536665
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Task-Specific Step Training on Reactive Balance After Laboratory-Induced Trips: A Pilot Trial
- ClinicalTrials.gov ID
- NCT05734443
- Acronym / sponsor ID
- 21-1072
- Conditions
- Accidental Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Posted 24 Sep 2025
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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| step training | Experimental | Behavioral: step trainingTwo 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. |
| treadmill training | Experimental | Behavioral: treadmill trainingTwo 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 trainingParticipants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping. | Behavioural | step training |
| treadmill trainingSudden 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. | Behavioural | treadmill training |
Primary outcome
Trunk Angle at Touchdown of the First Recovery Step
Time frame: 1 week after the 3-week intervention
After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers
Trip Outcome
Time frame: 1 week after the 3-week intervention
This is a binary variable that has a value of either "fall" or "recovery." After a laboratory-induced trip, trip outcome will be assign to one of the following two values: "fall" if a participant is fully and continuously supported by the harness as observed from video, or if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is greater than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell. "recovery" if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is less than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell.
5 secondary outcomes
Recovery Step Length
Time frame: 1 week after the 3-week intervention
Sacrum Height at Touchdown of the First Recovery Step
Time frame: 1 week after the 3-week intervention
Gait Speed
Time frame: 1 week after the 3-week intervention
Average Step Speed
Time frame: 1 week after the 3-week intervention
Trip Recovery Strategy
Time frame: 1 week after the 3-week intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42536665Lee Y, Alexander NB, Franck CT, Castleberry J, Madigan ML. A pilot trial investigating feasibility and preliminary efficacy of a task-specific step training regimen to improve balance recovery among community-dwelling older adults. PLoS One. 2026 Jul 31;21(7):e0354677. doi: 10.1371/journal.pone.0354677. eCollection 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael L. Madigan, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing step training and treadmill training in people with Accidental Fall, run by Virginia Polytechnic Institute and State University at 1 site 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Angle at Touchdown of the First Recovery Step (time frame: 1 week after the 3-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05734443, which also lists 1 linked publication.
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 24 Sep 2025.