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Motor Learning Instructions for Amputation in Diabetes

N/A

Recruiting

Led By Szu-Ping Lee, PhD

Research Sponsored by University of Nevada, Las Vegas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have unilateral transtibial or transfemoral amputation

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial will examine if different types of rehabilitation instruction (external vs. internal focus) have different effects on learning a balance task for people with amputations or at risk of amputation (due to diabetes).

Who is the study for?

This trial is for adults over 18 with a single below-knee or above-knee amputation, who can walk at least 50 meters unaided and use their walking prosthesis well. They should be willing to visit UNLV six times and may have type II diabetes.Check my eligibility

What is being tested?

The study tests how different instructions (focusing on the body's movements vs. focusing on the outcome of the movement) affect learning a balance task in people with lower limb loss, including those at risk due to diabetes.See study design

What are the potential side effects?

Since this trial involves instructional methods rather than medication, traditional side effects are not expected. However, participants might experience fatigue or frustration during motor skill learning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had one leg amputated either below or above the knee.

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I use a walking prosthesis regularly and can move around well with it.

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I may or may not have type II diabetes.

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I can walk 50 meters by myself.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in balance performance

Secondary outcome measures

Change in fall recovery performance

Change in patient's self-reported outcomes

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Diabetes (External Focus)Experimental Treatment1 Intervention

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.

Group II: Amputees (External Focus)Experimental Treatment1 Intervention

Group III: Diabetes (Internal Focus)Active Control1 Intervention

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.

Group IV: Amputees (Internal Focus)Active Control1 Intervention

0 / 5Eligibility criteria met

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,674,686 Total Patients Enrolled

5 Trials studying Diabetes

2,288 Patients Enrolled for Diabetes

University of Nevada, Las VegasLead Sponsor

66 Previous Clinical Trials

13,744 Total Patients Enrolled

Szu-Ping Lee, PhDPrincipal InvestigatorUniversity of Nevada, Las Vegas

Media Library

Diabetes Research Study Groups: Diabetes (Internal Focus), Amputees (External Focus), Amputees (Internal Focus), Diabetes (External Focus)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate quantity of participants in this trial?

"Affirmative. Per the information posted on clinicaltrials.gov, this medical trial is presently looking for 55 individuals to partake in their research from 1 different facility. The study was initially listed on October 1st 2019 and its last update occurred July 27th 2022."

Answered by AI

Is recruitment currently underway for this experimental trial?

"As verified on clinicaltrials.gov, this medical research currently has an open call for participants. The trial was initially announced 10/1/2019 and the last update occurred 7/27/2022."

Answered by AI