Instructions to perform a motor task (external vs. internal focus instructions) for Diabetic Neuropathy
Phase-Based Progress Estimates
Effectiveness
Safety
Diabetic Neuropathy+2 MoreInstructions to perform a motor task (external vs. internal focus instructions) - Behavioral
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
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
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: BehavioralDiabetes (External Focus)
Behavioral
Experimental Group · 1 Intervention: Instructions to perform a motor task (external vs. internal focus instructions) · Intervention Types: BehavioralAmputees (Internal Focus)
Behavioral
ActiveComparator Group · 1 Intervention: Instructions to perform a motor task (external vs. internal focus instructions) · Intervention Types: BehavioralDiabetes (Internal Focus)
Behavioral
ActiveComparator Group · 1 Intervention: Instructions to perform a motor task (external vs. internal focus instructions) · Intervention Types: BehavioralTrial 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.
References
- Chiviacowsky, Suzete, Gabriele Wulf, and Raquel Wally. 2010. “An External Focus of Attention Enhances Balance Learning in Older Adults”. Gait & Posture. Elsevier BV. doi:10.1016/j.gaitpost.2010.08.004.
- 2019. "Motor Learning in Individuals With Lower Limb Loss and Chronic Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03989063.
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