Motor Learning in Individuals With Lower Limb Loss and Chronic Diabetes
2 other identifiers
interventional
55
1 country
1
Brief Summary
Inadequate rehabilitation training after amputation can result in poor patient outcomes, injuries, and wasted healthcare resources. This is a serious public health problem due to an aging population and rising prevalence of diabetes (main cause of amputation in the U.S.). In this study, the investigators will examine the effects of external vs. internal attentional focus instruction on learning of a balance task in individuals with existing amputation and those at risk of amputation (older adults with diabetes). With the proposed research, the investigators aim to expand the understanding of motor learning in individuals with and at risk of lower limb loss to provide knowledge that will lead to more effective and efficient rehabilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 28, 2022
July 1, 2022
4.3 years
June 4, 2019
July 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in balance performance
During each 30-second balance practice trial, time in balance which is defined as when the balance platform is within 5 degrees from horizontal will be measured in seconds. A longer time in balance (up to 30 seconds) indicates better balance performance.
Throughout the training period (2 days, up to 40 trials) and during the post-training tests
Change in balance performance
During each balance practice trial, average deviation of balance platform angle from horizontal will be measured in degrees. Smaller deviation from horizontal indicates better balance performance.
Throughout the balance training period (2 days, up to 40 trials) and during the post-training tests
Secondary Outcomes (4)
Change in fall recovery performance
Before and after balance training. The after training assessment will be conducted 2-10 days after the conclusion of the balance training.
Change in fall recovery performance
Before and after the 2-day balance training. The after training assessment will be conducted 2-10 days after the conclusion of the balance training.
Change in fall recovery performance
Before and after the 2-day balance training. The after training assessment will be conducted 2-10 days after the conclusion of the balance training.
Change in patient's self-reported outcomes
Throughout the balance training period (2 days, assessed every 5 practice trials).
Study Arms (4)
Amputees (External Focus)
EXPERIMENTALParticipants in this group will receive the external focus instruction on where to direct their attention while training to perform the balance task. During training, the assigned instruction will be reinforced at the beginning and after every 5 practice trials.
Amputees (Internal Focus)
ACTIVE COMPARATORParticipants in this group will receive the internal focus instruction on where to direct their attention while training to perform the balance task. During training, the assigned instruction will be reinforced at the beginning and after every 5 practice trials.
Diabetes (External Focus)
EXPERIMENTALParticipants in this group will receive the external focus instruction on where to direct their attention while training to perform the balance task. During training, the assigned instruction will be reinforced at the beginning and after every 5 practice trials.
Diabetes (Internal Focus)
ACTIVE COMPARATORParticipants in this group will receive the internal focus instruction on where to direct their attention while training to perform the balance task. During training, the assigned instruction will be reinforced at the beginning and after every 5 practice trials.
Interventions
During the balance task, the participants will receive instructions to focus on external targets (external focus group) vs. movement of the body (internal focus group).
Eligibility Criteria
You may qualify if:
- Have unilateral transtibial or transfemoral amputation,
- Age \>18 years,
- Are fitted with a walking prosthesis and use it regularly and proficiently (K-level of 2 or above, further defined as scoring higher 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.
- Age \>18 years,
- With or without a current diagnosis of type II diabetes
- Able to walk for at least 50 meters without assistance from other people,
- 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 functions 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154, United States
Related Publications (1)
Chiviacowsky S, Wulf G, Wally R. An external focus of attention enhances balance learning in older adults. Gait Posture. 2010 Oct;32(4):572-5. doi: 10.1016/j.gaitpost.2010.08.004. Epub 2010 Sep 17.
PMID: 20850325BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Szu-Ping Lee, PhD
University of Nevada, Las Vegas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants are randomly assigned to one of the two parallel groups receiving either external or internal attentional focus instructions for the same balance task. Participants will be blinded to this group assignment until final debriefing.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2019
First Posted
June 18, 2019
Study Start
October 1, 2019
Primary Completion
December 31, 2023
Study Completion
June 30, 2024
Last Updated
July 28, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share
The individual participant data (IPD) collected in this study is specific to the study protocol only. Sharing of the IPD to other researchers would pose a risk to participant privacy, and is not scientifically merited.