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AmputationNCT03989063

Motor Learning in Individuals With Lower Limb Loss and Chronic Diabetes

A study testing Instructions to perform a motor task (external vs. internal focus instructions) in people with Amputation and Diabetes Mellitus, run by University of Nevada, Las Vegas at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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.). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Instructions to perform a motor task (external vs. internal focus instructions)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
1 Oct 2019to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • The inclusion criteria (non-amputee older adults with and without chronic diabetes):
Show all 11Show fewer
  • 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. -

Who cannot join

  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

Szu-Ping Lee, PhD contact

7028953086

szu-ping.lee@unlv.edu

Szu-Ping Lee, PhD contact

3528704767

szupinglee@gmail.com

United States1 site, 1 recruiting
  • University of Nevada, Las Vegas

    Las Vegas, Nevada, 89154

    Szu-Ping Lee, PhD, 702-895-3086, szu-ping.lee@unlv.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description
  1. Prior to participation in the study, the purpose and procedures of the study, including possible image and video recordings, will be explained to the subjects.
  2. Subjects will then be required to give written consent for their participation and will receive a copy of their consent form.
  3. The following 2-part research protocol uses a similar experimental protocol (learning a balance task) on individuals with leg amputation (Part 1), and individuals with chronic diabetes (Part 2).

Part 1:

The experiment will take place over a 3-day period including screening and baseline testing (Visit 1), balance training (Visits 2), and retention testing (Visit 3; at least 24 hours after Visit 2). On Visit 1, the investigators will assess aspects of health and functional capacity to assess participation eligibility and establish baseline characteristics of the participants. In addition to medical history and anthropometric measurements, the assessment will consist of clinical surveys of quality of life, physical activity level, balance confidence, and fear of falling. Ambulatory performance will be quantified. Additional amputee-specific measures will be used to assess functional characteristics unique to the population.

The balance training involves standing and maintaining balance on a stabilometer, which consists of a platform (1.3m long by 1.4m wide) connected to a single axis that allows bi-directional sway (Lafayette Instrument Co.; Figure 1). The maximum angular deviation of the platform is 18°. A safety harness is provided to prevent falls but does not provide support during the performance of the task. The load on the harness will be monitored with an S-type strain gauge (Delsys Inc., Massachusetts, USA) connected in series to the harness tether. Participants are required to maintain balance with feet in a medial-lateral orientation while standing on the balance board and looking straight ahead. A potentiometer monitors the sway angle of the platform. An integrated timer measures time in balance, which is defined as when the platform angle is within ± 5° of horizontal.[52] The primary outcome measure is time in balance (sec.) for each 30s trial. The secondary outcome measure is platform angular deviation from horizontal (RMSE; degree).

Participants will be assigned to receive the 2 attentional focus conditions in random order. Depending on the condition, participants will receive either internal or 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. After they complete training with the first condition, they will go through a washout period (at least 4 weeks) before receiving training under the other condition. Participants will be blinded to the purpose of the intervention and study design until debriefing at the end of the study.

The training will take place over a 2-day period (Visits 1 and 2), the investigators will monitor the changes in balance task performance over 40 total practice trials (20 trials each visit). The balance training consists of thirty 30s trials with a 90s rest interval between trials. During the rest interval, the platform will be locked to provide a stable surface or the participant can choose to step off the platform to sit down and rest when needed. After each 5 trials, participants will be given feedback regarding their performance (time in balance). No additional feedback will be provided. This protocol has been validated in the older adult population (mean age 69.4 years) in a previous study (Chiviacowsky et al. 2010). After each training block of 5 trials, the participant's self-perceived direction of attentional focus and spontaneous comments during the practice will be checked. The retention test will be performed at least 24 hours after the 2nd training day (Visit 3). The retention test will consist of performing 10 trials of the same balance task during which the participant will not receive any instructions, reminders, or feedback. An additional 10 trials of skill transfer task will be performed with an added cognitive task (counting numbers backward).

Part 2 (individuals with diabetes):

The procedure of Part 2 of this research is identical to Part 1. The main differences, in addition to the different participant population are described below.

In addition to the baseline health and functional capacity assessments as described in Part 1, the investigators will assess all participants' sensorimotor function using an established knee joint reposition sense test on a Cybex Norm dynamometer (Computer Sports Medicine Inc., Stoughton, MA, USA). This test assesses participant's ability to reproduce a joint angle using only proprioception. The test performance will be measured as the absolute error in degrees between the reproduced and target angles. This specific test was chosen to quantify the lower limb sensorimotor function because previous studies have shown it to be predictive of mobility outcomes in older adults in general and in those with diabetes. The investigators will determine individuals with diabetes-related sensorimotor impairment if the error is greater than 3.65°.

Individuals will be randomly assigned to receive either internal or external focus instructions conditions during the balance training. The experimental protocols and procedures will be the same as in Aim 1, including the screening (Visit 1), balance training (Visits 2), and retention and skill transfer testing (Visit 3; at least 24 hours after Visit 2).

Being tested
Instructions to perform a motor task (external vs. internal focus instructions)
Keywords
Motor Learning, Attentional Focus, Limb Loss, Diabetes, Balance
Medical subject headings
Diabetes Mellitus, Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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).

Study groups in NCT03989063
Study groupRoleWhat they receive
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.
Receives: Behavioral: Instructions to perform a motor task (external vs. internal focus instructions)
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.
Receives: Behavioral: Instructions to perform a motor task (external vs. internal focus instructions)
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.
Receives: Behavioral: Instructions to perform a motor task (external vs. internal focus instructions)
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.
Receives: Behavioral: Instructions to perform a motor task (external vs. internal focus instructions)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Throughout the training period (2 days, up to 40 trials) and during the post-training tests

  2. 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.

    Measured: Throughout the balance training period (2 days, up to 40 trials) and during the post-training tests

Secondary outcomes (4)
  1. Change in fall recovery performance

    Rate of successful recovery from 10 trials of simulated tripping/slipping perturbation during walking on a treadmill will be measured in percentage. Higher percentage of successful recovery indicates better fall recovery performance.

    Measured: Before and after balance training. The after training assessment will be conducted 2-10 days after the conclusion of the balance training.

  2. Change in fall recovery performance

    Trunk flexion angle during slipping/tripping (degrees). Previous studies have shown that smaller trunk angle during simulated tripping/slipping is associated with successful fall recovery. Smaller trunk flexion angle indicates better fall recovery performance.

    Measured: 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.

  3. Change in fall recovery performance

    Trunk angular velocity during slipping/tripping (degree/second). Previous studies have shown that slower trunk angle change (i.e. lower trunk angular velocity) during simulated tripping/slipping is associated with successful fall recovery. Slower trunk angular velocity indicates better fall recovery performance.

    Measured: 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.

  4. Change in patient's self-reported outcomes

    Self-efficacy regarding the performance of the balance task is assessed using a 4-question survey. An example question is: "How confident are you that you can keep yourself in balance for 15 out of 30 seconds?". Participant's response to each question is measured using a 0-10 scale. Higher confidence indicates greater self-efficacy.

    Measured: Throughout the balance training period (2 days, assessed every 5 practice trials).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start1 Oct 2019
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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
Parallel groups
Model description
Participants are randomly assigned to one of the two conditions receiving either external or internal attentional focus instructions for the same balance task. After a washout period of at least 1 month, the participant will repeat the experiment with instruction not previously received (i.e. if the participant received the internal focus instruction during the first phase, he/she will receive the external focus instruction in the second phase).
Masking
Single blind
Who is masked
Participant
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03989063
Sponsor's protocol ID
1299365
Other IDs
1K01HD091449-01A1
Status last verified
Jul 2022
First submitted
4 Jun 2019
Last updated
28 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 20850325
  • Lee SP, Shih HT, Wu FL, Armagnac R, Lee Y, Letkiewicz A, Mamauag M, Hooyman A, Winstein C. Effects of Diabetes and Attentional Focus on Learning of a Novel Balance Task. J Neurol Phys Ther. 2025 Jan 1;49(1):42-50. doi: 10.1097/NPT.0000000000000501. Epub 2024 Nov 26.

    PubMed 39656162

Questions about this trial

What is this clinical trial studying?

A study testing Instructions to perform a motor task (external vs. internal focus instructions) in people with Amputation and Diabetes Mellitus, 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 11 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Szu-Ping Lee, PhD (7028953086, 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?

Change in balance performance (time frame: Throughout the training period (2 days, up to 40 trials) and during the post-training tests). The study lists 2 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 NCT03989063, which also lists 2 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 28 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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