Fall PreventionPhase 1/2NCT07094659
Aging and Task-specific Training to Reduce Falls
A Phase 1/2 study testing Task-Specific Balance Training, Treadmill Perturbation Training and Conventional Balance Training in people with Fall Prevention, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine the effects of a novel task-specific balance training for reducing environmental falls in community ambulatory older adults who are at-risk of falling. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention
- What is being tested?
- Task-Specific Balance Training, Treadmill Perturbation Training and Conventional Balance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 31 Aug 2029
- Phase
- Phase 1/2
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 to 90 years of age to include community dwelling older adults
- Understand English to ensure ability to safely complete study protocols
- Able to walk independently for 1 block and 10 meters without an assistive device to ensure ability to complete exercises and reactive balance assessments
- 'At-risk' adults: Participants who report experience of at least 1 fall in the past 12 months or participants who are categorized as at high fall- risk using our fall risk prediction model which can predict the risk of both slip and trip related falls.
Who cannot join
- Major surgery less than 6 months ago to avoid complications due to training
- Hospitalization less than 3 months ago to avoid complications due to training
- Taking any sedative drugs to avoid interference with training
- Acute or uncontrolled neurological or cardiopulmonary or musculoskeletal or cancer diagnosis to avoid complications due to training
- Have intact visual and auditory ability with or without corrective aids to avoid confounding effects on balance
- Severe osteoporosis measured by a score of less than negative two point five on heel bone density scan to avoid complications due to training
Show all 9Show fewer
- Loss of sensation on monofilament test to avoid confounding effects on outcome assessments
- Cognitive impairment indicated by a score of less than 25 out of 30 on the mini mental state exam to ensure ability to follow instructions for safety
- Shortness of breath or uncontrolled pain higher than a three out of ten or inability to achieve age specified minimal distance on the 6 minute walk test for endurance to avoid complications due to training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60622
Tanvi Bhatt, PT, PhD, 312-355-4443, tbhatt6@uic.edu
About this study
Official title: Aging and Task-Specific Training to Reduce Falls
The goal of this clinical trial is to examine the effects of a novel task-specific balance training for reducing environmental falls in community ambulatory older adults who are at-risk of falling. The main questions it aims to answer are:
- Does task-specific balance training improve the ability to prevent falling when unexpected perturbations such as slips and trips occur, and/or improve balance control during self-initiated movements?
- Does task-specific balance training reduce real-life falls for 18 months after training?
Read more
Researchers will compare task-specific balance training with conventional balance training and treadmill perturbation-based training to examine how this novel intervention compares to established interventions for improving balance.
Participants who participate in the study will be asked to do the following:
- Complete a pre-training assessment of their balance control, and then be randomized to one of three training groups: 1) task-specific balance training, 2) treadmill perturbation-based training, and 3) conventional balance training
- Complete their assigned training protocol for 8 weeks (2x per week for a total of 16 sessions)
- Complete 2 post-training assessments of their balance control, the first being completed immediately after the training is completed, and the second being completed 18 months after the training is completed
- Wear a physical activity monitor for 18 months after completing the intervention to monitor their real life falls.
Read the detailed description
The proposed study employs a randomized, controlled design to assess the immediate and long-term effects of task-specific balance training for reducing environmental falls in at-risk community-ambulatory older adults. >33% of older adults fall at least once each year, leading to serious injuries (e.g., hip fractures), comorbidities (e.g., Alzheimer's Disease and related dementias), and higher chances of falling again. Most falls occur due to environmental disturbances which cause a loss of balance while walking (i.e., slips, trips). Our lab has established that overground perturbation training (repeated exposure to unpredicted perturbations) improves balance control in both predictable (i.e., volitional/anticipatory) and unpredictable (i.e., reactive) environments, and reduces real-life falls among older adults. However, overground perturbation training is not suitable for routine clinical application due to its complex design, space, and technology requirements. An alternative method for delivering perturbation training is via commercial treadmill systems, which enhance fall-resisting skills and are more feasible for community-translation. However, treadmill perturbation training still requires costly equipment and has lower translational effectiveness for reducing falls in community-ambulatory older adults than overground training. This may be because treadmill perturbation training mainly trains reactive balance control, while falls may also occur due to deficits in volitional balance control which affect gait stability during daily tasks. Volitional balance training has primarily comprised of conventional balance exercises delivered as a part of physical rehabilitation; however, conventional balance exercises generally do not translate to improvements in reactive balance control when exposed to unpredicted perturbations and have limited effects on reducing real-life falls. A fall prevention intervention that targets both volitional and reactive balance control could more effectively reduce falls in at-risk older adults than existing paradigms which only train a single domain (e.g., reactive-dominant treadmill perturbation training or volitional-dominant conventional balance training). We have developed a novel balance training program that includes both volitional-based task-specific exercises and reactive-based predictable perturbations to target the strategies involved in preventing slip- and trip-falls. This task-specific balance training requires little set-up and equipment, making it cost-effective, feasible and accessible. We will examine the immediate effects of 8 weeks (16 sessions) of task-specific balance training on reactive balance (Aim 1) and volitional balance (Aim 2), compared with established fall prevention paradigms (treadmill perturbation training and conventional balance training). Additionally, we will evaluate the longer-term retention (18 months) of task-specific balance training and effects on real-life falls and falls efficacy (Aim 3). In an exploratory aim, we will also examine the neuromuscular adaptations induced through training using muscle synergy analysis (Aim 4). If successful, our novel intervention could be implemented as a feasible, safe, and effective fall prevention intervention, with large potential for direct dissemination to clinical settings.
- Conditions
- Fall Prevention
- Being tested
- Task-Specific Balance Training, Treadmill Perturbation Training, Conventional Balance Training
- Keywords
- balance, fall risk, fall prevention, slips, trips, older adults, reactive balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-Specific Balance TrainingBehavioural
Participants in the intervention groups will receive 8 weeks of task-specific balance training that includes both functional tasks and predictable perturbations specific to slips and trips. Sessions will be completed 2x per week for 8 weeks (16 sessions total).
Treadmill Perturbation TrainingBehavioural
Participants in the treadmill perturbation training group will receive 8 weeks of training that includes exposure to slip-like and trip-like perturbations delivered via motorized treadmill. Sessions will be completed 2x per week for 8 weeks (16 sessions total).
Conventional Balance TrainingBehavioural
Participants in the conventional balance training group will receive 8 weeks of training that includes conventional exercises designed to improve balance control. Sessions will be completed 2x per week for 8 weeks (16 sessions total).
| Study group | Role | What they receive |
|---|---|---|
| Task-Specific Balance Training | Experimental | Participants in the task-specific balance training group will receive 8 weeks of task-specific balance training that includes both functional tasks and predictable perturbations specific to slips and trips. Sessions will be completed 2x per week for 8 weeks (16 sessions total). Receives: Behavioral: Task-Specific Balance Training |
| Treadmill Perturbation Training | Active comparator | Participants in the treadmill perturbation training group will receive 8 weeks of training that includes exposure to slip-like and trip-like perturbations delivered via motorized treadmill. Sessions will be completed 2x per week for 8 weeks (16 sessions total). Receives: Behavioral: Treadmill Perturbation Training |
| Conventional Balance Training | Active comparator | Participants in the conventional balance training group will receive 8 weeks of training that includes conventional exercises designed to improve balance control. Sessions will be completed 2x per week for 8 weeks (16 sessions total). Receives: Behavioral: Conventional Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Stability
Center of mass position will be computed via Helen Hayes marker set using an eight-camera motion capture system and normalized by foot length. The center of mass velocity will be computed by the first order derivative of the center of mass position and normalized to acceleration due to gravity and participant's body height. Reactive stability will be calculated as the shortest perpendicular distance from the center of mass state (position and velocity) to the dynamic feasible theoretical boundary for loss of balance. Reactive stability values less than 0 indicate greater instability in the backward direction, while values greater than 1 indicate greater instability in the forward direction.
Measured: Immediately post and at 18 months
Vertical Limb support
Limb support will be quantified by change in vertical limb support upon the perturbation hip height. The hip height, Zhip, will be obtained as the vertical distance of the bilateral hip midpoint to the surface of the platform. Its positive direction is upward. Zhip will be normalized to bh. Change in Zhip at recovery foot touchdown and its minimum value post-perturbation from its pre-perturbation value will be extracted.
Measured: Immediately post and at 18 months
Laboratory falls
Falls on laboratory perturbation will be identified when the peak load cell force, which is attached to the full-body safety harness exceeds 30% of participant body weight. This will further be verified by video recordings.
Measured: Immediately post and at 18 months
Functional Gait Assessment
The functional gait assessment assesses dynamic postural stability and the ability to perform multiple motor tasks during walking, including 10 items where the researcher rates the participant's ability (from 0-3) to perform 10 different gait tasks, such as walking with the eyes closed, walking up stairs, and walking with changes in gait speed. We selected the FGA to determine training-induced improvements in volitional balance control as it highly mimics scenarios which might be encountered during ambulation in daily living.
Measured: Baseline, Immediately post and at 18 months
Real-life falls
Participants will be sent a weekly text inquiring if they experienced a fall or loss of balance that day. If participants respond "yes," they will be followed up with a phone call to inquire about fall details. Participants can also choose to mail in fall logs if they opt out of weekly messaging. Real-life fall data will also be supplemented with daily device-recording using wrist-worn ActiGraph Accelerometers.
Measured: Recorded retrospectively (12 months before training) and weekly for 18 months post-training
Activities-specific Balance Confidence Scale (ABC)
Falls efficacy will be assessed using the Activities-Specific Balance Confidence Scale (ABC), which asks individuals to rate their level of confidence (0-100%) that they will not lose their balance while performing various activities of daily living, such as getting onto an escalator or reaching into a cabinet. An overall score of 0% indicates no confidence, while a score of 100% indicates complete confidence.
Measured: Baseline, Immediately post and at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start15 Aug 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Tanvi Bhatt, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094659
- Sponsor's protocol ID
- 2024-0959
- Other IDs
- 2R01AG050672-06A1
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging and Task-Specific Training to Reduce Falls
- ClinicalTrials.gov ID
- NCT07094659
- Acronym / sponsor ID
- 2024-0959
- Conditions
- Fall Prevention
- Keywords
- balance, fall risk, fall prevention, slips, trips, older adults, reactive balance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 30 Jul 2025 (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 examine the effects of a novel task-specific balance training for reducing environmental falls in community ambulatory older adults who are at-risk of falling. The main questions it aims to answer are:
- Does task-specific balance training improve the ability to prevent falling when unexpected perturbations such as slips and trips occur, and/or improve balance control during self-initiated movements?
- Does task-specific balance training reduce real-life falls for 18 months after training?
Researchers will compare task-specific balance training with conventional balance training and treadmill perturbation-based training to examine how this novel intervention compares to established interventions for improving balance.
Participants who participate in the study will be asked to do the following:
- Complete a pre-training assessment of their balance control, and then be randomized to one of three training groups: 1) task-specific balance training, 2) treadmill perturbation-based training, and 3) conventional balance training
- Complete their assigned training protocol for 8 weeks (2x per week for a total of 16 sessions)
- Complete 2 post-training assessments of their balance control, the first being completed immediately after the training is completed, and the second being completed 18 months after the training is completed
- Wear a physical activity monitor for 18 months after completing the intervention to monitor their real life falls.
Detailed description
The proposed study employs a randomized, controlled design to assess the immediate and long-term effects of task-specific balance training for reducing environmental falls in at-risk community-ambulatory older adults. >33% of older adults fall at least once each year, leading to serious injuries (e.g., hip fractures), comorbidities (e.g., Alzheimer's Disease and related dementias), and higher chances of falling again. Most falls occur due to environmental disturbances which cause a loss of balance while walking (i.e., slips, trips). Our lab has established that overground perturbation training (repeated exposure to unpredicted perturbations) improves balance control in both predictable (i.e., volitional/anticipatory) and unpredictable (i.e., reactive) environments, and reduces real-life falls among older adults. However, overground perturbation training is not suitable for routine clinical application due to its complex design, space, and technology requirements. An alternative method for delivering perturbation training is via commercial treadmill systems, which enhance fall-resisting skills and are more feasible for community-translation. However, treadmill perturbation training still requires costly equipment and has lower translational effectiveness for reducing falls in community-ambulatory older adults than overground training. This may be because treadmill perturbation training mainly trains reactive balance control, while falls may also occur due to deficits in volitional balance control which affect gait stability during daily tasks. Volitional balance training has primarily comprised of conventional balance exercises delivered as a part of physical rehabilitation; however, conventional balance exercises generally do not translate to improvements in reactive balance control when exposed to unpredicted perturbations and have limited effects on reducing real-life falls. A fall prevention intervention that targets both volitional and reactive balance control could more effectively reduce falls in at-risk older adults than existing paradigms which only train a single domain (e.g., reactive-dominant treadmill perturbation training or volitional-dominant conventional balance training). We have developed a novel balance training program that includes both volitional-based task-specific exercises and reactive-based predictable perturbations to target the strategies involved in preventing slip- and trip-falls. This task-specific balance training requires little set-up and equipment, making it cost-effective, feasible and accessible. We will examine the immediate effects of 8 weeks (16 sessions) of task-specific balance training on reactive balance (Aim 1) and volitional balance (Aim 2), compared with established fall prevention paradigms (treadmill perturbation training and conventional balance training). Additionally, we will evaluate the longer-term retention (18 months) of task-specific balance training and effects on real-life falls and falls efficacy (Aim 3). In an exploratory aim, we will also examine the neuromuscular adaptations induced through training using muscle synergy analysis (Aim 4). If successful, our novel intervention could be implemented as a feasible, safe, and effective fall prevention intervention, with large potential for direct dissemination to clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Task-Specific Balance Training | Experimental | Behavioral: Task-Specific Balance TrainingParticipants in the task-specific balance training group will receive 8 weeks of task-specific balance training that includes both functional tasks and predictable perturbations specific to slips and trips. Sessions will be completed 2x per week for 8 weeks (16 sessions total). |
| Treadmill Perturbation Training | Active comparator | Behavioral: Treadmill Perturbation TrainingParticipants in the treadmill perturbation training group will receive 8 weeks of training that includes exposure to slip-like and trip-like perturbations delivered via motorized treadmill. Sessions will be completed 2x per week for 8 weeks (16 sessions total). |
| Conventional Balance Training | Active comparator | Behavioral: Conventional Balance TrainingParticipants in the conventional balance training group will receive 8 weeks of training that includes conventional exercises designed to improve balance control. Sessions will be completed 2x per week for 8 weeks (16 sessions total). |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 to 90 years of age to include community dwelling older adults
- Understand English to ensure ability to safely complete study protocols
- Able to walk independently for 1 block and 10 meters without an assistive device to ensure ability to complete exercises and reactive balance assessments
- 'At-risk' adults: Participants who report experience of at least 1 fall in the past 12 months or participants who are categorized as at high fall- risk using our fall risk prediction model which can predict the risk of both slip and trip related falls.
Key exclusion criteria (9 listed)
- Major surgery less than 6 months ago to avoid complications due to training
- Hospitalization less than 3 months ago to avoid complications due to training
- Taking any sedative drugs to avoid interference with training
- Acute or uncontrolled neurological or cardiopulmonary or musculoskeletal or cancer diagnosis to avoid complications due to training
- Have intact visual and auditory ability with or without corrective aids to avoid confounding effects on balance
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 |
|---|---|---|
| Task-Specific Balance TrainingParticipants in the intervention groups will receive 8 weeks of task-specific balance training that includes both functional tasks and predictable perturbations specific to slips and trips. Sessions will be completed 2x per week for 8 weeks (16 sessions total). | Behavioural | Task-Specific Balance Training |
| Treadmill Perturbation TrainingParticipants in the treadmill perturbation training group will receive 8 weeks of training that includes exposure to slip-like and trip-like perturbations delivered via motorized treadmill. Sessions will be completed 2x per week for 8 weeks (16 sessions total). | Behavioural | Treadmill Perturbation Training |
| Conventional Balance TrainingParticipants in the conventional balance training group will receive 8 weeks of training that includes conventional exercises designed to improve balance control. Sessions will be completed 2x per week for 8 weeks (16 sessions total). | Behavioural | Conventional Balance Training |
Primary outcome
Reactive Stability
Time frame: Immediately post and at 18 months
Center of mass position will be computed via Helen Hayes marker set using an eight-camera motion capture system and normalized by foot length. The center of mass velocity will be computed by the first order derivative of the center of mass position and normalized to acceleration due to gravity and participant's body height. Reactive stability will be calculated as the shortest perpendicular distance from the center of mass state (position and velocity) to the dynamic feasible theoretical boundary for loss of balance. Reactive stability values less than 0 indicate greater instability in the backward direction, while values greater than 1 indicate greater instability in the forward direction.
Vertical Limb support
Time frame: Immediately post and at 18 months
Limb support will be quantified by change in vertical limb support upon the perturbation hip height. The hip height, Zhip, will be obtained as the vertical distance of the bilateral hip midpoint to the surface of the platform. Its positive direction is upward. Zhip will be normalized to bh. Change in Zhip at recovery foot touchdown and its minimum value post-perturbation from its pre-perturbation value will be extracted.
Laboratory falls
Time frame: Immediately post and at 18 months
Falls on laboratory perturbation will be identified when the peak load cell force, which is attached to the full-body safety harness exceeds 30% of participant body weight. This will further be verified by video recordings.
Functional Gait Assessment
Time frame: Baseline, Immediately post and at 18 months
The functional gait assessment assesses dynamic postural stability and the ability to perform multiple motor tasks during walking, including 10 items where the researcher rates the participant's ability (from 0-3) to perform 10 different gait tasks, such as walking with the eyes closed, walking up stairs, and walking with changes in gait speed. We selected the FGA to determine training-induced improvements in volitional balance control as it highly mimics scenarios which might be encountered during ambulation in daily living.
Real-life falls
Time frame: Recorded retrospectively (12 months before training) and weekly for 18 months post-training
Participants will be sent a weekly text inquiring if they experienced a fall or loss of balance that day. If participants respond "yes," they will be followed up with a phone call to inquire about fall details. Participants can also choose to mail in fall logs if they opt out of weekly messaging. Real-life fall data will also be supplemented with daily device-recording using wrist-worn ActiGraph Accelerometers.
Activities-specific Balance Confidence Scale (ABC)
Time frame: Baseline, Immediately post and at 18 months
Falls efficacy will be assessed using the Activities-Specific Balance Confidence Scale (ABC), which asks individuals to rate their level of confidence (0-100%) that they will not lose their balance while performing various activities of daily living, such as getting onto an escalator or reaching into a cabinet. An overall score of 0% indicates no confidence, while a score of 100% indicates complete confidence.
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 6 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Task-Specific Balance Training, Treadmill Perturbation Training and Conventional Balance Training in people with Fall Prevention, run by University of Illinois at Chicago 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tanvi Bhatt, PT, PhD (312-355-4443, tbhatt6@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive Stability (time frame: Immediately post and at 18 months). The study lists 6 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 6 Jul 2026.