FallingNCT06076525
Motor Flexibility in Multidirectional Balance Control
A study of Falling, run by University of Nebraska.
Trial summary
The goal of this observational study is to learn about how older adults (those 65 and above) manage to maintain balance when experiencing a slip or trip while walking. The study is especially interested in how quickly and flexibly adjustments to movement can be made to avoid falling. Read more about this study
- Who is it for?
- Ages 19 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Falling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The proposed study will include individuals from two distinct age ranges, between 19 to 35 years old and 65 to 79 years old. This approach ensures a wide demographic representation and allows for comparison across different age groups.
Who cannot join
- Uncontrolled hypertension
- Peripheral arterial disease
- Knee osteoarthritis
- Vertigo
- Meniere's disease
- Chronic dizziness
Show all 9Show fewer
- History of back or lower extremity injury that currently limits completing multidirectional perturbation protocol
- Prior surgery that affects the subject's mobility
- Any neurological disease or impairment that limits the ability to walk, including but not limited to stroke, Parkinson's disease, and multiple sclerosis.
About this study
Official title: Understanding Motor Flexibility and Reactive Balance Control to Improve Fall Prevention Strategies in Older Adults
The goal of this observational study is to learn about how older adults (those 65 and above) manage to maintain balance when experiencing a slip or trip while walking. The study is especially interested in how quickly and flexibly adjustments to movement can be made to avoid falling. The main questions this study aims to answer are:
- How does the ability to adjust movements quickly, also known as "motor flexibility," affect the chances of recovering from a slip or trip?
- Can targeted training improve this ability in older adults, making falls less likely? Participants will walk on a specially designed treadmill that can simulate slips and trips and undergo a training program designed to improve the ability to adjust movements quickly.
Researchers will compare older adults to younger adults to see if age affects the ability to adjust movements quickly and recover balance after a slip or trip. Researcher's will also compare the performance of older adults before and after the training program to see if balance recovery improves.
Read the detailed description
Falls are the leading cause of injury-related fatalities in people aged 65 and above, often triggered by unexpected disruptions like slips or trips during walking. Such events necessitate rapid and adaptable motor responses to regain balance, a mechanism referred to as "reactive balance control." Within this complex interplay, "motor flexibility," or the ability to modulate one's movements in real-time based on sensory feedback, becomes critical. However, there exists a trade-off: increased flexibility requires more complex sensory processing, potentially delaying the initiation of corrective actions-a delay that can prove perilous in the context of a fall. This study seeks to explore the role of motor flexibility in reactive balance control, particularly in older adults, with a focus on understanding how individuals adapt stepping patterns in response to diverse and unpredictable balance disturbances. State-of-the-art technology will be employed including a Computer-Assisted Rehabilitation Environment (CAREN), to simulate various types of walking surface disruptions. By studying younger and older adults and introducing different types of perturbations, the study aims to understand the trade-offs between the speed of motor response and the flexibility to adapt to different fall scenarios. Additionally, the extent to which training can improve this balance control flexibility is investigated. The central hypothesis is that motor flexibility is a modifiable feature of reactive balance control and is positively correlated with the ability to recover from multi-directional disturbances. The study will quantify this relationship and assess the potential for improvement through targeted interventions. Aim 1 of the research is designed to measure these trade-offs in older adults by introducing controlled perturbations to a walking platform, thereby providing critical data on how speed and flexibility interact in real-world fall scenarios. Computational models will be used to evaluate how these variables contribute to an individual's ability to resist falls from varying directions and magnitudes. Aim 2 will explore the potential for improving balance control flexibility through targeted training, studying both younger and older adults to gauge the effects of age on the adaptability of motor control. Improvements in balance flexibility and determine how these changes interact with other physiological factors like body mass index and rate of force development. The results of this study will provide foundational data that can be used to develop more effective fall-prevention strategies for older adults. This research bridges biomechanics and computational modeling, offering an interdisciplinary lens through which to view a problem of substantial public health significance. By understanding the nuances of how motor flexibility and reaction speed interact in the context of unexpected balance disturbances, we aim to make strides in mitigating the risks and consequences of falls in older adults.
- Conditions
- Falling
- Being tested
- Multidirectional Perturbations for Balance Control Assessment (60 perturbations), Multidirectional Perturbations for Balance Control Assessment (150 perturbations)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidirectional Perturbations for Balance Control Assessment (60 perturbations)Behavioural
The intervention involves exposing participants to a series of 60 controlled multidirectional perturbations while walking on a treadmill. These perturbations are delivered in varying directions and magnitudes to simulate real-world conditions that might lead to a loss of balance, such as slips or trips. Participants will undergo this series during multiple experimental sessions referred to as epochs. The complete intervention consists of a treadmill familiarization period followed by 5 epochs to assess motor flexibility. Each epoch is followed by a rest period to ensure participant safety and minimize fatigue.
Multidirectional Perturbations for Balance Control Assessment (150 perturbations)Behavioural
The intervention involves exposing participants to a series of 150 controlled multidirectional perturbations while walking on a treadmill. These perturbations are delivered in varying directions and magnitudes to simulate real-world conditions that might lead to a loss of balance, such as slips or trips. Participants will undergo this series during multiple experimental sessions referred to as epochs. The complete intervention consists of a treadmill familiarization period followed by seven epochs. The first five epochs will deliver multidirectional perturbations to assess modifiability of motor flexibility, followed by a sixth epoch to test generalization to novel perturbation directions while walking. Finally there will be a seventh epoch of perturbations while standing to test generalization from walking balance control to standing balance control. Each epoch is followed by a rest period to ensure participant safety and minimize fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Older Adult Fallers (participate in Aim 1 only) | Experimental | This group is exposed to the perturbations during treadmill walking in Aim 1 to collect data on their balance control mechanisms. Receives: Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations) |
| Older Adult Non-Fallers - Control Group (participate in Aims 1 and 2) | Active comparator | This group acts as a comparison for the Older Adult Non-Fallers - Experimental Group within the same demographic. Receives: Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations) |
| Older Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2) | Experimental | This group is exposed to the interventions in both Aims 1 and 2, the latter of which involves targeted training designed to improve their balance control flexibility. Receives: Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations); Behavioral: Multidirectional Perturbations for Balance Control Assessment (150 perturbations) |
| Younger Adult Non-Fallers - Control Group (participate in Aims 1 and 2) | Active comparator | This group serves as the control for the Younger Adult Non-Fallers - Experimental Group. Receives: Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations) |
| Younger Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2) | Experimental | This group is exposed to the interventions in both Aims 1 and 2, the latter of which involves targeted training designed to improve their balance control flexibility. Receives: Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations); Behavioral: Multidirectional Perturbations for Balance Control Assessment (150 perturbations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Flexibility Index in Reactive Balance Control
The Motor Flexibility Index is quantified using the coefficient of determination (R-squared) from a linear regression model that predicts recovery step placement based on the multi-directional motion state of the upper body 100 milliseconds after disturbance onset. A higher R-squared value indicates better motor flexibility, reflecting an individual's ability to adaptively respond to unexpected balance disturbances.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Jul 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Why it stopped: Protocol not submitted to IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Parallel Assignment interventional study aimed at investigating the role of behavioral flexibility in multidirectional balance control and fall prevention across different age groups and fall histories. The study will recruit 42 participants divided into three groups: 14 Older Adult Fallers, 14 Older Adult Non-Fallers, and 14 Younger Adult Non-Fallers. Participants will undergo treadmill walking sessions where perturbations in different directions and magnitudes will be introduced. Older Adult Non-Fallers and Younger Adult Non-Fallers will partake in two different aims, involving walking sessions and training epochs. Due to concerns over fatigue, Older Adult Fallers will only participate in one of these aims. The study aims to provide insight into the trade-offs between speed and flexibility in reactive balance control, and the potential for improving balance through targeted interventions.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathaniel H Hunt, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076525
- Sponsor's protocol ID
- UNebraska
- Status last verified
- Aug 2024
- First submitted
- 1 Oct 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie the results reported in publications arising from this study will be shared, including demographic data, behavioral assessments, and outcomes. This will also encompass data dictionaries to enable future researchers to understand the variables used. No sensitive identification information will be included in the shared dataset to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Motor Flexibility and Reactive Balance Control to Improve Fall Prevention Strategies in Older Adults
- ClinicalTrials.gov ID
- NCT06076525
- Acronym / sponsor ID
- UNebraska
- Conditions
- Falling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol not submitted to IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 11 Oct 2023 (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 observational study is to learn about how older adults (those 65 and above) manage to maintain balance when experiencing a slip or trip while walking. The study is especially interested in how quickly and flexibly adjustments to movement can be made to avoid falling. The main questions this study aims to answer are:
- How does the ability to adjust movements quickly, also known as "motor flexibility," affect the chances of recovering from a slip or trip?
- Can targeted training improve this ability in older adults, making falls less likely? Participants will walk on a specially designed treadmill that can simulate slips and trips and undergo a training program designed to improve the ability to adjust movements quickly.
Researchers will compare older adults to younger adults to see if age affects the ability to adjust movements quickly and recover balance after a slip or trip. Researcher's will also compare the performance of older adults before and after the training program to see if balance recovery improves.
Detailed description
Falls are the leading cause of injury-related fatalities in people aged 65 and above, often triggered by unexpected disruptions like slips or trips during walking. Such events necessitate rapid and adaptable motor responses to regain balance, a mechanism referred to as "reactive balance control." Within this complex interplay, "motor flexibility," or the ability to modulate one's movements in real-time based on sensory feedback, becomes critical. However, there exists a trade-off: increased flexibility requires more complex sensory processing, potentially delaying the initiation of corrective actions-a delay that can prove perilous in the context of a fall. This study seeks to explore the role of motor flexibility in reactive balance control, particularly in older adults, with a focus on understanding how individuals adapt stepping patterns in response to diverse and unpredictable balance disturbances. State-of-the-art technology will be employed including a Computer-Assisted Rehabilitation Environment (CAREN), to simulate various types of walking surface disruptions. By studying younger and older adults and introducing different types of perturbations, the study aims to understand the trade-offs between the speed of motor response and the flexibility to adapt to different fall scenarios. Additionally, the extent to which training can improve this balance control flexibility is investigated. The central hypothesis is that motor flexibility is a modifiable feature of reactive balance control and is positively correlated with the ability to recover from multi-directional disturbances. The study will quantify this relationship and assess the potential for improvement through targeted interventions. Aim 1 of the research is designed to measure these trade-offs in older adults by introducing controlled perturbations to a walking platform, thereby providing critical data on how speed and flexibility interact in real-world fall scenarios. Computational models will be used to evaluate how these variables contribute to an individual's ability to resist falls from varying directions and magnitudes. Aim 2 will explore the potential for improving balance control flexibility through targeted training, studying both younger and older adults to gauge the effects of age on the adaptability of motor control. Improvements in balance flexibility and determine how these changes interact with other physiological factors like body mass index and rate of force development. The results of this study will provide foundational data that can be used to develop more effective fall-prevention strategies for older adults. This research bridges biomechanics and computational modeling, offering an interdisciplinary lens through which to view a problem of substantial public health significance. By understanding the nuances of how motor flexibility and reaction speed interact in the context of unexpected balance disturbances, we aim to make strides in mitigating the risks and consequences of falls in older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- This is a Parallel Assignment interventional study aimed at investigating the role of behavioral flexibility in multidirectional balance control and fall prevention across different age groups and fall histories. The study will recruit 42 participants divided into three groups: 14 Older Adult Fallers, 14 Older Adult Non-Fallers, and 14 Younger Adult Non-Fallers. Participants will undergo treadmill walking sessions where perturbations in different directions and magnitudes will be introduced. Older Adult Non-Fallers and Younger Adult Non-Fallers will partake in two different aims, involving walking sessions and training epochs. Due to concerns over fatigue, Older Adult Fallers will only participate in one of these aims. The study aims to provide insight into the trade-offs between speed and flexibility in reactive balance control, and the potential for improving balance through targeted interventions.
| Arm | Type | Receives |
|---|---|---|
| Older Adult Fallers (participate in Aim 1 only) | Experimental | Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations)This group is exposed to the perturbations during treadmill walking in Aim 1 to collect data on their balance control mechanisms. |
| Older Adult Non-Fallers - Control Group (participate in Aims 1 and 2) | Active comparator | Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations)This group acts as a comparison for the Older Adult Non-Fallers - Experimental Group within the same demographic. |
| Older Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2) | Experimental | Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations), Behavioral: Multidirectional Perturbations for Balance Control Assessment (150 perturbations)This group is exposed to the interventions in both Aims 1 and 2, the latter of which involves targeted training designed to improve their balance control flexibility. |
| Younger Adult Non-Fallers - Control Group (participate in Aims 1 and 2) | Active comparator | Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations)This group serves as the control for the Younger Adult Non-Fallers - Experimental Group. |
| Younger Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2) | Experimental | Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations), Behavioral: Multidirectional Perturbations for Balance Control Assessment (150 perturbations)This group is exposed to the interventions in both Aims 1 and 2, the latter of which involves targeted training designed to improve their balance control flexibility. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The proposed study will include individuals from two distinct age ranges, between 19 to 35 years old and 65 to 79 years old. This approach ensures a wide demographic representation and allows for comparison across different age groups.
Key exclusion criteria (9 listed)
- Uncontrolled hypertension
- Peripheral arterial disease
- Knee osteoarthritis
- Vertigo
- Meniere's disease
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 |
|---|---|---|
| Multidirectional Perturbations for Balance Control Assessment (60 perturbations)The intervention involves exposing participants to a series of 60 controlled multidirectional perturbations while walking on a treadmill. These perturbations are delivered in varying directions and magnitudes to simulate real-world conditions that might lead to a loss of balance, such as slips or trips. Participants will undergo this series during multiple experimental sessions referred to as epochs. The complete intervention consists of a treadmill familiarization period followed by 5 epochs to assess motor flexibility. Each epoch is followed by a rest period to ensure participant safety and minimize fatigue. | Behavioural | Older Adult Fallers (participate in Aim 1 only), Older Adult Non-Fallers - Control Group (participate in Aims 1 and 2), Older Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2), Younger Adult Non-Fallers - Control Group (participate in Aims 1 and 2), Younger Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2) |
| Multidirectional Perturbations for Balance Control Assessment (150 perturbations)The intervention involves exposing participants to a series of 150 controlled multidirectional perturbations while walking on a treadmill. These perturbations are delivered in varying directions and magnitudes to simulate real-world conditions that might lead to a loss of balance, such as slips or trips. Participants will undergo this series during multiple experimental sessions referred to as epochs. The complete intervention consists of a treadmill familiarization period followed by seven epochs. The first five epochs will deliver multidirectional perturbations to assess modifiability of motor flexibility, followed by a sixth epoch to test generalization to novel perturbation directions while walking. Finally there will be a seventh epoch of perturbations while standing to test generalization from walking balance control to standing balance control. Each epoch is followed by a rest period to ensure participant safety and minimize fatigue. | Behavioural | Older Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2), Younger Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2) |
Primary outcome
Motor Flexibility Index in Reactive Balance Control
Time frame: Immediately after intervention
The Motor Flexibility Index is quantified using the coefficient of determination (R-squared) from a linear regression model that predicts recovery step placement based on the multi-directional motion state of the upper body 100 milliseconds after disturbance onset. A higher R-squared value indicates better motor flexibility, reflecting an individual's ability to adaptively respond to unexpected balance disturbances.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie the results reported in publications arising from this study will be shared, including demographic data, behavioral assessments, and outcomes. This will also encompass data dictionaries to enable future researchers to understand the variables used. No sensitive identification information will be included in the shared dataset to protect participant privacy.
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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.
Nathaniel H Hunt, PhD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study of Falling, run by University of Nebraska.
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 1 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: withdrawn, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Motor Flexibility Index in Reactive Balance Control (time frame: Immediately after intervention). 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 5 Sep 2024.