AmputationNCT06638723
Enhancing Motor Function in Individuals with Lower Limb Amputation
A study testing Balance and fall recovery training in people with Amputation, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Balance and fall recovery training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154
Szu-Ping Lee, PhD, 7028953086, szu-ping.lee@unlv.edu
Fu-Lien Wu, PhD, 2132758254, fu-lien.wu@unlv.edu
About this study
Official title: Enhancing Motor Function in Individuals with Lower Limb Amputation Through Peer-Based Balance and Fall Recovery Skill Training
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)?
Read more
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.
Read the 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.
- Conditions
- Amputation
- Being tested
- Balance and fall recovery training
- Keywords
- limb loss, peer support, motor learning, EEG, falls, balance, prosthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance and fall recovery trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: 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." Receives: Behavioral: Balance and fall recovery training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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."
Measured: During the 6-visit training (3 months from the first to last visit)
Secondary outcomes (2)
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.
Measured: 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 demonstration video-watching, participants' brain activity will be assessed using a non-invasive, battery-powered EEG recording system with 64 electrodes on their head.
Measured: During video observations at the beginning of the 6-visit training (1st and 4th visits). The training is 3-months long.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start30 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Szu-Ping Lee, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638723
- Sponsor's protocol ID
- UNLV-2022-99
- Other IDs
- W81XWH-22-1-0216
- Status last verified
- Oct 2024
- First submitted
- 27 Nov 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently not a plan to share participant data with other researchers.
Publications
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.
PubMed 18295618Wulf 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.
PubMed 21988153Cusack 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.
PubMed 26438442
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Motor Function in Individuals with Lower Limb Amputation Through Peer-Based Balance and Fall Recovery Skill Training
- ClinicalTrials.gov ID
- NCT06638723
- Acronym / sponsor ID
- UNLV-2022-99
- Conditions
- Amputation
- Keywords
- limb loss, peer support, motor learning, EEG, falls, balance, prosthetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Amputee peers | Experimental | Behavioral: Balance and fall recovery trainingThis 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." |
| Non-amputees | Experimental | Behavioral: Balance and fall recovery trainingIn 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." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance and fall recovery trainingFollowing 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. | Behavioural | Amputee peers, Non-amputees |
Primary outcome
Balance performance
Time frame: 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.
Fall recovery performance (frequency)
Time frame: 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)
Time frame: 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
Patient's self-reported psychometric outcomes
Time frame: 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."
2 secondary outcomes
Visual focus assessment using eye tracking
Time frame: 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)
Time frame: During video observations at the beginning of the 6-visit training (1st and 4th visits). The training is 3-months long.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 18295618Ziegler-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.
- Background: PubMed 21988153Wulf 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.
- Background: PubMed 26438442Cusack 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.
- Individual participant dataSharing planned: No. There is currently not a plan to share participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Szu-Ping Lee, PhD principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance and fall recovery training in people with Amputation, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Szu-Ping Lee, PhD (702-895-3086, szu-ping.lee@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance performance (time frame: During the 6-visit training (3 months from the first to last visit)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06638723, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.