Recruiting

Motor Function

Sponsor:

University of Nevada, Las Vegas

Code:

NCT06638723

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Balance and fall recovery training

Study Details

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

Study ID

NCT06638723

Start date

Jun 30, 2023

Status verified date

Oct, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Amputee peers

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."

experimental: Non-amputees

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."

Interventions

Balance and fall recovery training

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.

Primary outcome measure

  • Balance performance [ Time Frame: During the 6-visit training (3 months from the first to last visit) ]
  • Fall recovery performance (frequency) [ Time Frame: During the 6-visit training (3 months from the first to last visit) ]
  • Fall recovery performance (movement quality) [ Time Frame: During the 6-visit training (3 months from the first to last visit) ]
  • Patient's self-reported psychometric outcomes [ Time Frame: During the 6-visit training (3 months from the first to last visit) ]

Central Contacts and Locations

Central contacts

Szu-Ping Lee, PhD

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

Joel Snyder, PhD

7028954692joel.snyder@unlv.edu

Locations

University of Nevada, Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89154

Contacts

Szu-Ping Lee, PhD

7028953086szu-ping.lee@unlv.edu

Fu-Lien Wu, PhD

2132758254fu-lien.wu@unlv.edu

More Information

Sponsor

University of Nevada, Las Vegas

Last update posted

Oct 15, 2024

Last verified

Oct, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nevada, Las Vegas on 2024-10-15.