Clinical trial NCT06638723: Enhancing Motor Function in Individuals with Lower Limb Amputation
Official title: Enhancing Motor Function in Individuals with Lower Limb Amputation Through Peer-Based Balance and Fall Recovery Skill Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Keywords: limb loss
peer support
motor learning
EEG
falls
balance
prosthetics
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The same group of participants will experience the two conditions, separated by a 4-week washout period. The initial condition is randomly decided.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Balance performance
timeFrame: During the 6-visit training (3 months from the first to last visit)
measure: Fall recovery performance (frequency)
timeFrame: During the 6-visit training (3 months from the first to last visit)
measure: Fall recovery performance (movement quality)
timeFrame: During the 6-visit training (3 months from the first to last visit)
measure: Patient's self-reported psychometric outcomes
timeFrame: During the 6-visit training (3 months from the first to last visit)
Secondary outcomes:
measure: Visual focus assessment using eye tracking
timeFrame: During video observations at the beginning of the 6-visit training (1st and 4th visits). The training is 3-months long.
measure: Brain activation pattern assessment using electroencephalography (EEG)
timeFrame: During video observations at the beginning of the 6-visit training (1st and 4th visits). The training is 3-months long.
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas
state: Nevada
Study officials:
affiliation: University of Nevada, Las Vegas
name: Szu-Ping Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
citation: Wulf G, Chiviacowsky S, Lewthwaite R. Altering mindset can enhance motor learning in older adults. Psychol Aging. 2012 Mar;27(1):14-21. doi: 10.1037/a0025718. Epub 2011 Oct 10.
citation: Cusack WF, Thach S, Patterson R, Acker D, Kistenberg RS, Wheaton LA. Enhanced Neurobehavioral Outcomes of Action Observation Prosthesis Training. Neurorehabil Neural Repair. 2016 Jul;30(6):573-82. doi: 10.1177/1545968315606992. Epub 2015 Oct 5.