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Procedure
With Somatosensation Device for Amputation
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, during the intervention
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can wear a device on my legs.
Select...
I can wear test equipment and heart rate monitors.
Select...
I have had a below-knee amputation or suffer from neuropathy in my legs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, during the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, during the intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Gait Assessment (FGA)
Secondary outcome measures
10 Meter Walk Test
Activities Specific Balance Confidence Scale (ABC)
Mini-BESTest
+1 moreTrial 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
194 Previous Clinical Trials
16,892 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for prospective participants of this clinical trial?
"According to clinicaltrials.gov, this medical trial is no longer open for enrollment after being initially posted on December 1st 2023 and last revised on the 4th of that same month. Despite this, there are still 91 other studies actively seeking participants at present."
Answered by AI
Is this research project open to individuals who are younger than seventy-five years old?
"This research is open to any individual that meets the age criteria of being above 18 and under 65 years old."
Answered by AI
What criteria is necessary to be an eligible participant in this research program?
"To gain admittance to this trial, patients must have undergone amputation and be between 18-65 years of age. The research team are seeking a total of 20 participants."
Answered by AI
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