Sensory Feedback for Touch and Proprioception With Prosthetic Limbs

November 17, 2023 updated by: Paul Marasco, Louis Stokes VA Medical Center

Sensory Feedback Tactor Systems for Implementation of Physiologically Relevant Cutaneous Touch and Proprioception With Prosthetic Limbs

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Edmonton, Alberta, Canada, T5B0B7
        • University of Alberta Glenrose Rehabilitation Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Rehabilitation Institute of Chicago
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Lerner Research Institute
      • Cleveland, Ohio, United States, 44106
        • Louis Stokes VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Amputees who have undergone targeted sensory reinnervation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Upper Extremity Amputee
Robust custom tactor to facilitate embodiment and proprioception
Able Bodied
Bypass tactor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embodiment of the Prosthetic limb
Time Frame: Ten months
Visual loading for fine motor tasks,questionnaires, and residual limb temperature will be assessed after 10 months of in home every day use of a custom robust tactor array for sensory feedback.
Ten months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the perceptions of limb movement
Time Frame: 6 months
Test how closely both targeted reinnervation amputees and able bodied study participants are able to interpret limb movement using the kinesthetic perceptual illusion and physiologically relevant kinesthetic feedback.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paul Marasco, PhD, Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimated)

July 14, 2014

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 11061-H39
  • R01NS081710-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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