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Sensory Feedback for Touch and Proprioception With Prosthetic Limbs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189031
Recruitment Status : Enrolling by invitation
First Posted : July 14, 2014
Last Update Posted : February 21, 2020
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)
The Cleveland Clinic
HDT Global
University of Alberta
Shirley Ryan AbilityLab
Defense Advanced Research Projects Agency
Information provided by (Responsible Party):
Paul Marasco, Louis Stokes VA Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Prosthetic Device: Tactor array Device: Bypass Tactor

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.

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Study Type : Observational
Estimated Enrollment : 49 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sensory Feedback Tactor Systems for Implementation of Physiologically Relevant Cutaneous Touch and Proprioception With Prosthetic Limbs
Study Start Date : February 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Upper Extremity Amputee
Robust custom tactor to facilitate embodiment and proprioception
Device: Tactor array
Able Bodied
Bypass tactor
Device: Bypass Tactor



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Amputees who have undergone targeted sensory reinnervation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189031


Locations
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United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Ohio
Louis Stokes VA Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Lerner Research Institute
Cleveland, Ohio, United States, 44195
Canada, Alberta
University of Alberta Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada, T5B0B7
Sponsors and Collaborators
Louis Stokes VA Medical Center
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)
The Cleveland Clinic
HDT Global
University of Alberta
Shirley Ryan AbilityLab
Defense Advanced Research Projects Agency
Investigators
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Principal Investigator: Paul Marasco, PhD Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute
Additional Information:
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Responsible Party: Paul Marasco, Director of Amputee Research, Louis Stokes VA Medical Center
ClinicalTrials.gov Identifier: NCT02189031    
Other Study ID Numbers: 11061-H39
R01NS081710-01 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Keywords provided by Paul Marasco, Louis Stokes VA Medical Center:
Upper limb Amputee
Targeted Muscle Reinnervation
Prosthetic