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Balance Control for Diabetic Neuropathy (DPN Trial)

N/A
Recruiting
Research Sponsored by Lisa Griffin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type II diabetes with peripheral neuropathy
Be older than 18 years old
Must not have
Foot ulcer
Partial amputation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first session (immediately after intervention)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study how diabetes affects balance and muscle activity in adults over 50 years old. The study will look at how people with diabetic peripheral neuropathy differ in muscle activity and balance control compared

Who is the study for?
This trial is for adults over 50 with diabetic peripheral neuropathy, which affects balance and muscle control. It's also for healthy aging individuals to compare results. Participants must be able to perform physical tasks like standing up from a seated position.
What is being tested?
The study tests how well people can control their balance during movements like sitting down or standing up, and how they recover from unexpected disturbances while standing. Muscle activity will be measured using MRI scans of the sciatic nerve.
What are the potential side effects?
There are no direct side effects mentioned for this trial as it involves non-invasive procedures such as movement exercises and MRI scans. However, there might be general discomfort or fatigue due to physical tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type II diabetes with nerve damage in my hands or feet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a foot ulcer.
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I have had a partial amputation.
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I have had a stroke in the past.
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I experience pain from nerve damage.
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I cannot stand or walk on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first session (immediately after intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and first session (immediately after intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Center of mass using Vicon cameras.
Center of pressure using force plate
Joint moment using Nexus software
+1 more
Secondary study objectives
Muscle amplitude using root mean square
Muscle co-activation index using EMG
Muscle energy frequency using EMG data
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: older adult with diabetic peripheral neuropathyExperimental Treatment4 Interventions
Group II: Healthy older adultActive Control4 Interventions
Group III: healthy younger adultActive Control4 Interventions

Find a Location

Who is running the clinical trial?

Lisa GriffinLead Sponsor
~34 spots leftby Aug 2026
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