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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diabetic Neuropathy+2 MoreInstructions to perform a motor task (external vs. internal focus instructions) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

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).

Eligible Conditions
  • Diabetic Neuropathy
  • Diabetes
  • Amputation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 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.

Day 10
Change in fall recovery performance
Day 2
Change in patient's self-reported outcomes
Day 2
Change in balance performance

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Amputees (Internal Focus)
1 of 4
Diabetes (Internal Focus)
1 of 4
Amputees (External Focus)
1 of 4
Diabetes (External Focus)
1 of 4

Active Control

Experimental Treatment

55 Total Participants · 4 Treatment Groups

Primary Treatment: Instructions to perform a motor task (external vs. internal focus instructions) · No Placebo Group · N/A

Amputees (External Focus)
Behavioral
Experimental Group · 1 Intervention: Instructions to perform a motor task (external vs. internal focus instructions) · Intervention Types: Behavioral
Diabetes (External Focus)
Behavioral
Experimental Group · 1 Intervention: Instructions to perform a motor task (external vs. internal focus instructions) · Intervention Types: Behavioral
Amputees (Internal Focus)
Behavioral
ActiveComparator Group · 1 Intervention: Instructions to perform a motor task (external vs. internal focus instructions) · Intervention Types: Behavioral
Diabetes (Internal Focus)
Behavioral
ActiveComparator Group · 1 Intervention: Instructions to perform a motor task (external vs. internal focus instructions) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

University of Nevada, Las VegasLead Sponsor
53 Previous Clinical Trials
10,986 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,824 Previous Clinical Trials
2,249,368 Total Patients Enrolled
Szu-Ping Lee, PhDPrincipal InvestigatorUniversity of Nevada, Las Vegas

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a unilateral transtibial or transfemoral amputation.
You are willing to travel to UNLV 6 times for training and testing.
You are fitted with a prosthetic limb and use it regularly and proficiently.
You are able to stand for at least 5 minutes without using an assistive device or experiencing excessive fatigue.
You are willing to travel to UNLV for training and testing.
You are able to walk for at least 50 meters without assistance from other people.