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Somatosensation Device Trial

NCT ID: NCT06168396

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-05-01

Brief Summary

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This research is being done to test a new device, called the Somatosensation Device, with people who have either a below knee amputation, or neuropathy (i.e. decreased sensation) in their legs. When people have lost sensation in their feet, it may make walking and balance more difficult. The Somatosensation Device is designed to substitute the loss of feeling in a foot by pressing on nerves on the surface of the leg. It presses on the nerves by using a pneumatic balloon to put pressure on your skin. If people receive this extra sensation feedback, it may help improve their walking and balance.

Detailed Description

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Conditions

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Amputation Neuropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Baseline (Without Somatosensation Device)

Participants will perform all outcome measures without wearing the somatosensation device.

Group Type ACTIVE_COMPARATOR

Baseline

Intervention Type OTHER

Participants will perform outcome measures without wearing the somatosensation device.

With Somatosensation Device

Participants will perform all outcome measures while wearing the somatosensation device.

Group Type EXPERIMENTAL

Somatosensation Device

Intervention Type DEVICE

The somatosensation device will be worn on the lower limb (either the residual limb for an amputee, or limb with decreased sensation for a participant with diabetic neuropathy) while performing outcome measures.

Interventions

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Somatosensation Device

The somatosensation device will be worn on the lower limb (either the residual limb for an amputee, or limb with decreased sensation for a participant with diabetic neuropathy) while performing outcome measures.

Intervention Type DEVICE

Baseline

Participants will perform outcome measures without wearing the somatosensation device.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have a below-knee amputation (either unilateral or bilateral) or neuropathy in their lower limbs.
* Ability to wear the somatosensation device on their lower limbs
* Ability to wear test equipment and heart rate monitors.
* Ability to follow simple directions.

Exclusion Criteria

* History of severe back pain in the last 3 months.
* History of severe knee pain in the last 3 months.
* Unable to walk for 3 minutes with or without an assistive device
* Poor skin integrity (i.e open wounds, skin breakdown) that could be made worse by wearing the somatosensation device.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

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Arun Jayaraman, PT, PhD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00219855

Identifier Type: -

Identifier Source: org_study_id