Sensory Feedback for Touch and Proprioception With Prosthetic Limbs
Sensory Feedback Tactor Systems for Implementation of Physiologically Relevant Cutaneous Touch and Proprioception With Prosthetic Limbs
2 other identifiers
observational
49
2 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2013
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 21, 2023
March 1, 2023
11.6 years
July 8, 2014
November 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Embodiment of the Prosthetic limb
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 Outcomes (1)
Investigate the perceptions of limb movement
6 months
Study Arms (2)
Upper Extremity Amputee
Robust custom tactor to facilitate embodiment and proprioception
Able Bodied
Bypass tactor
Interventions
Eligibility Criteria
Amputees who have undergone targeted sensory reinnervation
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Louis Stokes VA Medical Centerlead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- National Institutes of Health (NIH)collaborator
- The Cleveland Cliniccollaborator
- HDT Globalcollaborator
- University of Albertacollaborator
- Shirley Ryan AbilityLabcollaborator
- Defense Advanced Research Projects Agencycollaborator
Study Sites (4)
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Louis Stokes VA Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Lerner Research Institute
Cleveland, Ohio, 44195, United States
University of Alberta Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5B0B7, Canada
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Marasco, PhD
Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Amputee Research
Study Record Dates
First Submitted
July 8, 2014
First Posted
July 14, 2014
Study Start
February 1, 2013
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
November 21, 2023
Record last verified: 2023-03