Motor Flexibility in Multidirectional Balance Control

NCT ID: NCT06076525

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2029-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Falling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Multidirectional Perturbations for Balance Control Assessment (60 perturbations)

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Multidirectional Perturbations for Balance Control Assessment (60 perturbations)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Multidirectional Perturbations for Balance Control Assessment (60 perturbations)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Multidirectional Perturbations for Balance Control Assessment (60 perturbations)

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Multidirectional Perturbations for Balance Control Assessment (60 perturbations)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nathaniel H Hunt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UNebraska

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Enhanced Gait and Balance Training
NCT01896466 COMPLETED NA
Motor Training for Fall Prevention
NCT01621958 COMPLETED NA
Postural Control in the Elderly
NCT00059501 COMPLETED
Balance Control During Gait
NCT02231827 COMPLETED NA
Post-stroke Perturbation Training
NCT04855032 COMPLETED NA