Sensory Feedback for Touch and Proprioception With Prosthetic Limbs

Sponsor
Louis Stokes VA Medical Center (U.S. Fed)
Overall Status
Unknown status
CT.gov ID
NCT02189031
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH), National Institutes of Health (NIH) (NIH), The Cleveland Clinic (Other), HDT Global (Other), University of Alberta (Other), Shirley Ryan AbilityLab (Other), Defense Advanced Research Projects Agency (U.S. Fed)
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Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Feb 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Upper Extremity Amputee

Robust custom tactor to facilitate embodiment and proprioception

Device: Tactor array

Able Bodied

Bypass tactor

Device: Bypass Tactor

Outcome Measures

Primary Outcome Measures

  1. Embodiment of the Prosthetic limb [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rehabilitation Institute of Chicago Chicago Illinois United States 60611
2 Louis Stokes VA Medical Center Cleveland Ohio United States 44106
3 Cleveland Clinic Lerner Research Institute Cleveland Ohio United States 44195
4 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

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
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
First Posted:
Jul 14, 2014
Last Update Posted:
Feb 21, 2020
Last Verified:
Feb 1, 2020
Keywords provided by Paul Marasco, Director of Amputee Research, Louis Stokes VA Medical Center

Study Results

No Results Posted as of Feb 21, 2020