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Behavioural Intervention

Exploratory Arm for Numbness

N/A

Recruiting

Led By Arun Jayaraman, PT, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to ambulate 10 meters with or without assistance

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the intervention

Awards & highlights

Study Summary

This trial will investigate the use of a special device to help people with a movement disorder who have lost feeling in the bottom of their feet. The device has two parts - a flexible insole that can

Who is the study for?

This trial is for individuals with movement disorders leading to reduced sensation or numbness in the soles of their feet. Participants should be able to walk and have a stable condition, but specific details on age or other health requirements are not provided.Check my eligibility

What is being tested?

The study tests a haptic device designed to help people who can't feel their feet properly. It uses pressure sensors in an insole and a receiver that vibrates or heats up, aiming to replace the lost foot sensation.See study design

What are the potential side effects?

Potential side effects may include discomfort from vibrations or heat, skin irritation from wearing the device, and possible distraction due to unfamiliar sensations which could affect balance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can walk 10 meters by myself or with help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pressure data from the insoles

Trial Design

1Treatment groups

Experimental Treatment

Group I: Exploratory ArmExperimental Treatment1 Intervention

Individuals will complete standardized balance and walking tasks with and without sensory substitution from the haptic device system.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER

1,589 Previous Clinical Trials

917,026 Total Patients Enrolled

Querrey Simpson Institute for BioelectronicsUNKNOWN

Shirley Ryan AbilityLabLead Sponsor

194 Previous Clinical Trials

16,812 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently open?

"Indeed, the information provided on clinicaltrials.gov confirms that this research endeavor is currently in the process of recruiting eligible participants. The study was first posted on April 20th, 2023 and underwent its most recent update on January 22nd, 2024. A total of 100 individuals are being sought to participate at a single designated site."

Answered by AI

What is the current participation count in this clinical trial?

"Indeed, the data available on clinicaltrials.gov indicates that this study is actively enrolling patients. The trial was first posted on April 20th, 2023 and recently updated on January 22nd, 2024. A total of 100 participants are being sought from a single site for this study."

Answered by AI

What criteria must individuals meet in order to be eligible for participation in this clinical trial?

"In order to be eligible for this clinical study, participants must experience numbness and fall within the age range of 18 to 85. The trial aims to recruit a total of 100 patients."

Answered by AI

Are individuals who are 50 years or older eligible to participate in this clinical trial?

"According to the eligibility criteria outlined in this clinical trial, individuals as young as 18 and up to 85 years of age may be considered for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multimodal Haptic Feedback for Plantar Sensory Substitution

Arun Jayaraman, PT, PhD 2023. "Multimodal Haptic Feedback for Plantar Sensory Substitution". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06232512.

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