- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02189031
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
Intervention / Treatment
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
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Alberta
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Edmonton, Alberta, Canada, T5B0B7
- University of Alberta Glenrose Rehabilitation Hospital
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Illinois
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Chicago, Illinois, United States, 60611
- Rehabilitation Institute of Chicago
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Lerner Research Institute
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Cleveland, Ohio, United States, 44106
- Louis Stokes VA Medical Center
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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
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Able Bodied
Bypass tactor
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Embodiment of the Prosthetic limb
Time Frame: Ten months
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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.
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Ten months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigate the perceptions of limb movement
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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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