Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484244
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Locomotion Adaptation Deficits in Older Adults With Mild Cognitive Impairment and Alzheimers Disease
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Locomotion Adaptation Deficits in Older Adults With Mild Cognitive Impairment and Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In people with Mild Cognitive Impairment MCI and Alzheimers Disease AD reduced capacity for locomotor adaptation is a fundamental but poorly understood mechanism that can be a sensitive biomarker of cognitive-motor impairments It is also an important therapeutic target for exercise-based interventions to improve walking function The overall goal of this study is to understand the effects of MCI and AD on locomotor adaptation and walking function
Detailed Description:
In conjunction with cognitive impairments older adults with Alzheimers Disease AD and Mild Cognitive Impairment MCI show increased impairments in walking function throughout disease progression The ability to walk without the risk of falling is necessary for independent community activity and participation for elderly individuals However the relationships between cognition gait dysfunction and fall risk in people with MCI and AD are poorly understood warranting further study The objective of this study is to test the researchers central hypothesis that in people with MCI and AD decreased capacity for locomotor adaptation can worsen disease progression and lead to reduced motor-cognitive function mobility and quality of life
Community-based walking function requires complex motor coordination sensory feedback dynamic balance adaptation to changing environmental stimuli while also engaging in attentional tasks such as crossing a busy street or talking over the phone Unfortunately cognitive dysfunction the hallmark of MCI and AD directly impacts the cognitive-motor neural resources needed to carry out activities of daily living People with MCI and AD walk slower fall more and have deficits in gait performance variables such as stride symmetry and step regularity Importantly gait disturbances have often been shown to precede cognitive decline In this study the researchers propose to test their hypothesis that a decline in locomotor adaptation capacity may explain gait and mobility deficits in people with MCI and AD Locomotor adaptation is a fundamentally important process that enables humans to flexibility respond to environmental demands enabling normal community walking function Split-belt adaptation is a standardized robust well studied paradigm for quantifying a persons capacity for locomotor adaptation but had not yet been evaluated in people with MCI and AD Split-belt walking task assesses locomotor adaptation ie the ability to adjust stepping movements to changing environmental demands via trial-and-error processing The split-belt task is systematically assessed during treadmill walking where the speed of each leg can be controlled independently such that one belt and the corresponding leg run at a different speed eg twice as fast or a 21 speed ratio than the other leg In previous work both the magnitude and rate of split-belt adaptation as well as de-adaptation during the after-effect have provided objective measures of an individuals locomotor adaptation capacity
The researchers of this study hypothesize that decreased capacity for split-belt adaptation may be an important contributing factor and a potentially sensitive indicator of increased fall risk and cognitive decline in older individuals with MCI and AD
There are three study aims
Aim 1 compares split-belt locomotor adaptation and walking function in older adults with MCI and AD compared to age-similar controls Sixty participants 20 in each study group will complete 1 or 2 study visits comprising consent measurement of split-belt adaptation gait function gait performance and cognition
Aim 2 compares degradation in split-belt locomotor adaptation and walking function over time in older adults with MCI and AD compared to age-similar controls Twelve participants from Aim 1 will return for another study visit 6 months later to collect longitudinal data
Aim 3 evaluates the feasibility of a split-belt walking intervention on walking function in older adults with MCI and AD Ten participants 5 MCI and 5 AD will complete 5 split-belt treadmill walking exercise sessions over a 2-week period The primary and secondary outcome measures for this study are measured in evaluation sessions before Pre-training and after 5 training sessions Post-training
Community-based walking function requires complex motor coordination sensory feedback dynamic balance adaptation to changing environmental stimuli while also engaging in attentional tasks such as crossing a busy street or talking over the phone Unfortunately cognitive dysfunction the hallmark of MCI and AD directly impacts the cognitive-motor neural resources needed to carry out activities of daily living People with MCI and AD walk slower fall more and have deficits in gait performance variables such as stride symmetry and step regularity Importantly gait disturbances have often been shown to precede cognitive decline In this study the researchers propose to test their hypothesis that a decline in locomotor adaptation capacity may explain gait and mobility deficits in people with MCI and AD Locomotor adaptation is a fundamentally important process that enables humans to flexibility respond to environmental demands enabling normal community walking function Split-belt adaptation is a standardized robust well studied paradigm for quantifying a persons capacity for locomotor adaptation but had not yet been evaluated in people with MCI and AD Split-belt walking task assesses locomotor adaptation ie the ability to adjust stepping movements to changing environmental demands via trial-and-error processing The split-belt task is systematically assessed during treadmill walking where the speed of each leg can be controlled independently such that one belt and the corresponding leg run at a different speed eg twice as fast or a 21 speed ratio than the other leg In previous work both the magnitude and rate of split-belt adaptation as well as de-adaptation during the after-effect have provided objective measures of an individuals locomotor adaptation capacity
The researchers of this study hypothesize that decreased capacity for split-belt adaptation may be an important contributing factor and a potentially sensitive indicator of increased fall risk and cognitive decline in older individuals with MCI and AD
There are three study aims
Aim 1 compares split-belt locomotor adaptation and walking function in older adults with MCI and AD compared to age-similar controls Sixty participants 20 in each study group will complete 1 or 2 study visits comprising consent measurement of split-belt adaptation gait function gait performance and cognition
Aim 2 compares degradation in split-belt locomotor adaptation and walking function over time in older adults with MCI and AD compared to age-similar controls Twelve participants from Aim 1 will return for another study visit 6 months later to collect longitudinal data
Aim 3 evaluates the feasibility of a split-belt walking intervention on walking function in older adults with MCI and AD Ten participants 5 MCI and 5 AD will complete 5 split-belt treadmill walking exercise sessions over a 2-week period The primary and secondary outcome measures for this study are measured in evaluation sessions before Pre-training and after 5 training sessions Post-training
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AG084231 | NIH | None | None |