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Procedure

Somatosensation Device for Neuropathy

N/A
Recruiting
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to wear the somatosensation device on their lower limbs
Ability to wear test equipment and heart rate monitors.
Must not have
History of severe back pain in the last 3 months.
History of severe knee pain in the last 3 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, during the intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a device that, using pressure on the leg, provides sensation feedback to people who have lost feeling in their feet, to aid with walking and balance. #medtech

Who is the study for?
This trial is for individuals with a below-knee amputation or neuropathy in their lower limbs who can wear the Somatosensation Device and test equipment. They should be able to walk for at least 3 minutes and follow simple instructions. People with severe back or knee pain recently, or poor skin integrity that could worsen by wearing the device cannot participate.
What is being tested?
The study tests a new Somatosensation Device designed to improve walking and balance by providing sensation feedback through pressure on leg nerves. It uses a pneumatic balloon to apply this pressure, aiming to help those who've lost feeling in their feet due to amputation or neuropathy.
What are the potential side effects?
Potential side effects may include discomfort where the device presses on the skin, possible skin irritation from prolonged use of the device, and fatigue from physical testing during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can wear a device on my legs.
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I can wear test equipment and heart rate monitors.
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I have had a below-knee amputation or suffer from neuropathy in my legs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have experienced severe back pain in the last 3 months.
Select...
I have experienced severe knee pain in the last 3 months.
Select...
I cannot walk for 3 minutes, even with help or a device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, during the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, during the 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
Functional Gait Assessment (FGA)
Secondary study objectives
10 Meter Walk Test
Activities Specific Balance Confidence Scale (ABC)
Mini-BESTest
+1 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: With Somatosensation DeviceExperimental Treatment1 Intervention
Participants will perform all outcome measures while wearing the somatosensation device.
Group II: Baseline (Without Somatosensation Device)Active Control1 Intervention
Participants will perform all outcome measures without wearing the somatosensation device.

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Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
208 Previous Clinical Trials
18,005 Total Patients Enrolled
~0 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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