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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

Tracking Information
First Submitted Date July 8, 2014
First Posted Date July 14, 2014
Last Update Posted Date February 21, 2020
Study Start Date February 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 11, 2014)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sensory Feedback for Touch and Proprioception With Prosthetic Limbs
Official Title Sensory Feedback Tactor Systems for Implementation of Physiologically Relevant Cutaneous Touch and Proprioception With Prosthetic Limbs
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Amputees who have undergone targeted sensory reinnervation
Condition Prosthetic
Intervention
  • Device: Tactor array
  • Device: Bypass Tactor
Study Groups/Cohorts
  • Upper Extremity Amputee
    Robust custom tactor to facilitate embodiment and proprioception
    Intervention: Device: Tactor array
  • Able Bodied
    Bypass tactor
    Intervention: Device: Bypass Tactor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 11, 2014)
49
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02189031
Other Study ID Numbers 11061-H39
R01NS081710-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Paul Marasco, Louis Stokes VA Medical Center
Study Sponsor Louis Stokes VA Medical Center
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
Investigators
Principal Investigator: Paul Marasco, PhD Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute
PRS Account Louis Stokes VA Medical Center
Verification Date February 2020