- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06076525
Motor Flexibility in Multidirectional Balance Control
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nebraska
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Omaha, Nebraska, United States, 68182
- University of Nebraska-Omaha, Biomechanics Research Building
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Uncontrolled hypertension
- Peripheral arterial disease
- Knee osteoarthritis
- Vertigo
- Meniere's disease
- Chronic dizziness
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Older Adult Fallers (participate in Aim 1 only)
This group is exposed to the perturbations during treadmill walking in Aim 1 to collect data on their balance control mechanisms.
|
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.
|
Active Comparator: Older Adult Non-Fallers - Control Group (participate in Aims 1 and 2)
This group acts as a comparison for the Older Adult Non-Fallers - Experimental Group within the same demographic.
|
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.
|
Experimental: Older Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2)
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.
|
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.
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.
|
Active Comparator: Younger Adult Non-Fallers - Control Group (participate in Aims 1 and 2)
This group serves as the control for the Younger Adult Non-Fallers - Experimental Group.
|
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.
|
Experimental: Younger Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2)
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Immediately after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathaniel H Hunt, PhD, University of Nebraska
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UNebraska
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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