Enhancing Motor Function in Individuals with Lower Limb Amputation

NCT06638723 | Recruiting

• 2 other identifiers: UNLV-2022-99W81XWH-22-1-0216
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

limb loss; peer support; motor learning; EEG; falls; balance; prosthetics

Outcome Measures

Primary Outcomes (4)

• 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.

  During the 6-visit training (3 months from the first to last visit)

• Fall recovery performance (frequency)

  During fall recovery training, the incidence of falls during the trials will be recorded

  During the 6-visit training (3 months from the first to last visit)

• Fall recovery performance (movement quality)

  During fall recovery training, the trunk and lower extremity stepping kinematics during the trials will be recorded

  During the 6-visit training (3 months from the first to last visit)

• 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."

  During the 6-visit training (3 months from the first to last visit)

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Amputee peers

EXPERIMENTAL

This research uses a cross-over design to expose the participants with lower limb loss to the two training conditions (observing amputee peers vs. non-amputees) in random order, with a 4-week washout period between conditions. In this arm, participants are instructed to learn from video demonstrations by amputee peers. The videos will show balance and fall recovery movement tasks performed by the models, 15-30 seconds in length. The instruction to the participants is: "Please watch and learn the tasks as performed by the demonstrator. You (the participant) will be asked to perform these tasks later."

Behavioral: Balance and fall recovery training

Non-amputees

EXPERIMENTAL

In this arm, participants with lower limb loss are instructed to learn from video demonstrations by non-amputees. The videos will show balance and fall recovery movement tasks performed by the models, 15-30 seconds in length. The instruction to the participants is: "Please watch and learn the tasks as performed by the demonstrator. You (the participant) will be asked to perform these tasks later."

Behavioral: Balance and fall recovery training

Interventions

Balance and fall recovery training BEHAVIORAL

Following 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.

Amputee peers; Non-amputees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) have unilateral lower limb amputation,
• \) age \>18 years,
• \) 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),
• \) able to stand for at least 5 minutes without using an assistive device or experiencing excessive fatigue,
• \) willing to travel to UNLV 6 times for training and testing.

You may not qualify if:

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

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 18295618 BACKGROUND

• 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.

  PMID: 21988153 BACKGROUND

• 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.

  PMID: 26438442 BACKGROUND

Study Officials

• Szu-Ping Lee, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Szu-Ping Lee, PhD

CONTACT

702-895-3086; szu-ping.lee@unlv.edu

Joel Snyder, PhD

CONTACT

7028954692; joel.snyder@unlv.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were randomized to experience one of the two conditions (amputee peers vs. non-amputees) demonstrating how to perform motor tasks. Participants were masked to the study hypothesis and the existence of the other group.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The same group of participants will experience the two conditions, separated by a 4-week washout period. The initial condition is randomly decided.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: October 15, 2024
• Study Start: June 30, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)