Enhancing Motor Function in Individuals with Lower Limb Amputation
ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nevada, Las Vegas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Balance and fall recovery training
BehavioralFollowing the video observation described in the arms, participants will undergo training to physically practice the motor tasks. The training will take place over a 2-week period encompassing 40 practice trials for each task over the training sessions. During training, the investigators will continuously monitor the changes in balance and fall recovery task performance, and will provide feedback. Participants can request to re-watch the demonstration video that they were assigned to at any time.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Amputee peersExperimental treatment 1 intervention
Group B: Non-amputeesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Balance performance
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.
Time frame
During the 6-visit training (3 months from the first to last visit)2
Fall recovery performance (frequency)
During fall recovery training, the incidence of falls during the trials will be recorded
Time frame
During the 6-visit training (3 months from the first to last visit)3
Fall recovery performance (movement quality)
During fall recovery training, the trunk and lower extremity stepping kinematics during the trials will be recorded
Time frame
During the 6-visit training (3 months from the first to last visit)4
Patient's self-reported psychometric outcomes
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."
Time frame
During the 6-visit training (3 months from the first to last visit)Secondary outcomes
1
Visual focus assessment using eye tracking
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.
Time frame
During video observations at the beginning of the 6-visit training (1st and 4th visits). The training is 3-months long.2
Brain activation pattern assessment using electroencephalography (EEG)
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.
Time frame
During video observations at the beginning of the 6-visit training (1st and 4th visits). The training is 3-months long.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nevada, Las Vegas
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov