Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638723
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-11-27
Brief Title:
Enhancing Motor Function in Individuals with Lower Limb Amputation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhancing Motor Function in Individuals with Lower Limb Amputation Through Peer-Based Balance and Fall Recovery Skill Training
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this research project is to investigate the effectiveness and the science of peer-based prosthetic skill training in individuals with leg amputation Our belief is that amputee learners will show improved skill learning when observing demonstrations from other amputees as opposed to observing nonamputee models The investigators will accomplish the objective by answering the following two questions
Question 1 Does peer-based observation training works better for learning motor tasks for individuals with lower limb amputation LLA
Question 2 Are there differences in visual focus behavior and brain activation patterns when observing motor task demonstrations from amputee peers vs non-amputees
Participants of this study will be asked to learn a balance and a fall recovery task by observing video demonstrations by amputee peers vs non-amputees The investigators will compare which setting produce better learning
Question 1 Does peer-based observation training works better for learning motor tasks for individuals with lower limb amputation LLA
Question 2 Are there differences in visual focus behavior and brain activation patterns when observing motor task demonstrations from amputee peers vs non-amputees
Participants of this study will be asked to learn a balance and a fall recovery task by observing video demonstrations by amputee peers vs non-amputees The investigators will compare which setting produce better learning
Detailed Description:
ObjectiveHypothesis The overall objective of this project is to investigate the clinical scientific bases of peer observation sensori-motor skill training in individuals with lower limb amputation The general hypothesis is that participants observing models who share the same levels of amputation with them ie amputee peers will exhibit traits of enhanced motor learning when compared to observing non-amputee models Knowledge gained from this study will directly benefit the development of more effective rehabilitation protocols and has the potential to fundamentally transform the clinical practice of post-amputation rehabilitation
Aim 1 Determine the effects of peer-based observation training on sensori-motor performance and learning in individuals with LLA During a 2-week training period the investigators will assess the differences in task performance and learning outcomes between participants who are instructed to learn to perform the tasks ie balance and reactive fall arrest by observing video demonstrations from amputee peers vs non-amputees n20
Aim 2 Examine the differences in visual focus behavioral psychometrics and brain activation patterns during and after observing motor task demonstrations from amputee peers vs non-amputees The investigators will compare the differences in visual focus time task-specific self-efficacy adopted mindset and event-related brain activation patterns between the two conditions where participants learn to perform the motor tasks demonstrated by amputee peers vs non-amputees
Study Design This research will use a cross-over design with a washout period to expose the participants to the two conditions in random order In Aim 1 participants with unilateral LLA will be instructed to watch video demonstration of balance and fall recovery tasks performed by either an amputee peer or non-amputee with the intention of learning to perform the task The subsequent 2-week training will consist of 60 practice trials for each task over at least 3 sessions
Participants task performance measured by time-in-balance during the balance task and peak trunk flexion angle and rate of successful fall arrest during the fall recovery task will be tracked before throughout and after retention training To accomplish Aim 2 the investigators will evaluate and quantitatively measure the participants visual focus using eye tracking technology psychometric traits self-efficacy motivation and growth mindset and brain activation patterns assessed by electroencephalography EEG during the video observation and the corresponding training period
Aim 1 Determine the effects of peer-based observation training on sensori-motor performance and learning in individuals with LLA During a 2-week training period the investigators will assess the differences in task performance and learning outcomes between participants who are instructed to learn to perform the tasks ie balance and reactive fall arrest by observing video demonstrations from amputee peers vs non-amputees n20
Aim 2 Examine the differences in visual focus behavioral psychometrics and brain activation patterns during and after observing motor task demonstrations from amputee peers vs non-amputees The investigators will compare the differences in visual focus time task-specific self-efficacy adopted mindset and event-related brain activation patterns between the two conditions where participants learn to perform the motor tasks demonstrated by amputee peers vs non-amputees
Study Design This research will use a cross-over design with a washout period to expose the participants to the two conditions in random order In Aim 1 participants with unilateral LLA will be instructed to watch video demonstration of balance and fall recovery tasks performed by either an amputee peer or non-amputee with the intention of learning to perform the task The subsequent 2-week training will consist of 60 practice trials for each task over at least 3 sessions
Participants task performance measured by time-in-balance during the balance task and peak trunk flexion angle and rate of successful fall arrest during the fall recovery task will be tracked before throughout and after retention training To accomplish Aim 2 the investigators will evaluate and quantitatively measure the participants visual focus using eye tracking technology psychometric traits self-efficacy motivation and growth mindset and brain activation patterns assessed by electroencephalography EEG during the video observation and the corresponding training period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None