Motor Flexibility in Multidirectional Balance Control

NCT06076525 | Withdrawn

• 1 other identifier: UNebraska
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Falling

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after intervention

Study Arms (5)

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.

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.

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.

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.

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.

Behavioral: Multidirectional Perturbations for Balance Control Assessment (60 perturbations); Behavioral: Multidirectional Perturbations for Balance Control Assessment (150 perturbations)

Interventions

Multidirectional Perturbations for Balance Control Assessment (60 perturbations) 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 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) 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.

Older Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2); Younger Adult Non-Fallers - Experimental Group (participate in Aims 1 and 2)

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Officials

• Nathaniel H Hunt, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: October 11, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The IPD will become available starting 6 months after the publication of summary data and will remain accessible for a period of 5 years thereafter. This is to provide adequate time for the research team to fully analyze and publish initial findings, and to ensure that the IPD remains relevant and useful to the research community.
• Access Criteria: Access to IPD will be granted to qualified researchers for the purposes of conducting secondary analyses. Requests for IPD should be submitted to the principal investigator.