Sensory Feedback for Touch and Proprioception With Prosthetic Limbs

NCT ID: NCT02189031

Last Updated: 2023-11-21

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

UNKNOWN

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2024-09-30

Brief Summary

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Upper limb amputation is a devastating injury that leaves many thousands of typically young and active individuals in the US to rely on artificial arms and hands to help restore their lost function. The investigators research is focused on helping these individuals to feel where their prosthetic limbs are moving without having to look at them by developing devices and approaches to provide sensory feedback of limb movement through the nerves that once served the missing limb.

Detailed Description

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In the investigators research the investigators seek to understand the organization and (function/operation) of sensory neural systems in order to develop methods for restoring function to injured populations. One of the primary focus areas of the investigators research is working to integrate physiologically relevant sensory feedback with prosthetic limbs. To this end the investigators employ a variety of approaches that interweave disciplines such as electrophysiology, psychophysics, biomedical engineering and cognition. The investigators research team is composed of an interconnected and communicative network of clinicians, engineers, and scientists. This helps us to provide pathways from basic science discoveries that can be used to address clinical needs with transition directly to patient care.

Conditions

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Prosthetic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Upper Extremity Amputee

Robust custom tactor to facilitate embodiment and proprioception

Tactor array

Intervention Type DEVICE

Able Bodied

Bypass tactor

Bypass Tactor

Intervention Type DEVICE

Interventions

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Tactor array

Intervention Type DEVICE

Bypass Tactor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Amputee criteria:

* Must be over 18 years of age
* Must be upper extremity amputee who has undergone targeted sensory reinnervation.

Able Bodied participants:

* Must be over 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

HDT Global

UNKNOWN

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role collaborator

Defense Advanced Research Projects Agency

FED

Sponsor Role collaborator

Louis Stokes VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Paul Marasco

Director of Amputee Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Marasco, PhD

Role: PRINCIPAL_INVESTIGATOR

Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute

Locations

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Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Site Status

Louis Stokes VA Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Lerner Research Institute

Cleveland, Ohio, United States

Site Status

University of Alberta Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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R01NS081710-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11061-H39

Identifier Type: -

Identifier Source: org_study_id

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