Enhancing Motor Function in Individuals with Lower Limb Amputation

Not Applicable

Recruiting

• Conditions: Amputation

• Registration Number: NCT06638723
• Lead Sponsor: University of Nevada, Las Vegas

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.

Detailed Description

Objective/Hypothesis: 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 (i.e. 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 (i.e. balance and reactive fall arrest) by observing video demonstrations from amputee peers vs. non-amputees (n=20).

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).

Participant's 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 participant's 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 Timeline

• Study Start: 2023-06-30
• Study First Submitted: 2023-11-27
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1. have unilateral lower limb amputation,
• 2. age >18 years,
• 3. are properly fitted with a walking prosthesis and use it regularly with at least moderate proficiency (K-2 level or above, further defined as scoring greater than 50 percentile on the Prosthetic Limb Users Survey of Mobility),
• 4. able to stand for at least 5 minutes without using an assistive device or experiencing excessive fatigue,
• 5. willing to travel to UNLV 6 times for training and testing.

Exclusion Criteria

• 1. have other concurrent central nervous system diseases that influence motor function and balance,
• 2. have leg/foot ulcer or other conditions that cause pain during weight-bearing,
• 3. have cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Fall recovery performance (frequency)	During the 6-visit training (3 months from the first to last visit)	During fall recovery training, the incidence of falls during the trials will be recorded
Fall recovery performance (movement quality)	During the 6-visit training (3 months from the first to last visit)	During fall recovery training, the trunk and lower extremity stepping kinematics during the trials will be recorded
Balance performance	During the 6-visit training (3 months from the first to last visit)	During balance training, a potentiometer and a timer integrated to the balance platform will monitor the sway angle of the platform and time-in-balance, which is defined as when the platform angle is within ± 5° of horizontal. The primary outcome measure is time in balance (seconds) during each 30-second balance trial.
Patient's self-reported psychometric outcomes	During the 6-visit training (3 months from the first to last visit)	Surveys will be used to assess the participant's perceptions about the training, task-specific self-efficacy, and learning mindset.; Task-specific self-efficacy questions will be answered on an analog scale of 0-100 and included: "How difficult do you think the task is?", "How confident are you that you will be able to perform the task after practice?", and "How useful do you think this training is when applied to real life situations?".; Growth mindset survey will ask the participants to rate a series of statements including: "I can always improve how well I conduct a physical task (such as maintaining balance or walking).", "I only have a certain amount of physical capacity, and I can't really do much to change it.", "Hard work is needed to master skills needed for different tasks.", and "Other people's successes are inspiring. I can learn by their example."

Secondary Outcome Measures

Name	Time	Method
Visual focus assessment using eye tracking	During video observations at the beginning of the 6-visit training (1st and 4th visits). The training is 3-months long.	During demonstration video-watching, monocular recordings of the participant's eye movements will be recorded simultaneously by a desktop mounted eye-tracker. The coded data will be used to compare the visual attentional focus between the amputee-peers vs. non-amputee videos.
Brain activation pattern assessment using electroencephalography (EEG)	During video observations at the beginning of the 6-visit training (1st and 4th visits). The training is 3-months long.	During demonstration video-watching, participants' brain activity will be assessed using a non-invasive, battery-powered EEG recording system with 64 electrodes on their head.

Trial Locations

Locations (1)

University of Nevada, Las Vegas; 🇺🇸 Las Vegas, Nevada, United States