Recruiting

Observational Study

Sponsor:

University of Nevada, Las Vegas

Code:

NCT03989063

Conditions

Amputation

Diabetes Mellitus

Neuropathy, Diabetic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Instructions to perform a motor task (external vs. internal focus instructions)

Study Details

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.

Conditions

Amputation

Diabetes Mellitus

Neuropathy, Diabetic

Study ID

NCT03989063

Start date

Oct 1, 2019

Status verified date

Jul, 2022

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria (amputees):

1. Have unilateral transtibial or transfemoral amputation,
2. Age >18 years,
3. 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),
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.

The inclusion criteria (non-amputee older adults with and without chronic diabetes):

1. Age >18 years,
2. With or without a current diagnosis of type II diabetes
3. Able to walk for at least 50 meters without assistance from other people,
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 functions 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.

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Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Amputees (External Focus)

Participants 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.

active comparator: Amputees (Internal Focus)

Participants 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.

experimental: Diabetes (External Focus)

Participants 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.

active comparator: Diabetes (Internal Focus)

Participants 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

Instructions to perform a motor task (external vs. internal focus instructions)

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).

Primary outcome measure

  • Change in balance performance [ Time Frame: Throughout the training period (2 days, up to 40 trials) and during the post-training tests ]
  • Change in balance performance [ Time Frame: Throughout the balance training period (2 days, up to 40 trials) and during the post-training tests ]

Central Contacts and Locations

Central contacts

Szu-Ping Lee, PhD

7028953086szu-ping.lee@unlv.edu

Szu-Ping Lee, PhD

3528704767szupinglee@gmail.com

Locations

University of Nevada, Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89154

Contacts

Szu-Ping Lee, PhD

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

More Information

Sponsor

University of Nevada, Las Vegas

Last update posted

Jul 28, 2022

Last verified

Jul, 2022

Keywords

  • Motor Learning
  • Attentional Focus
  • Limb Loss
  • Diabetes
  • Balance

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 2022-07-28.