Clinical trial NCT02189031: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthetic
Keywords: Upper limb Amputee
Targeted Muscle Reinnervation
Prosthetic
Lead sponsor: Louis Stokes VA Medical Center
Sponsor class: FED
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Institutes of Health (NIH)
name: The Cleveland Clinic
name: HDT Global
name: University of Alberta
name: Shirley Ryan AbilityLab
name: Defense Advanced Research Projects Agency
First posted: 2014-07-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Amputees who have undergone targeted sensory reinnervation

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.

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

Primary outcomes:
measure: Embodiment of the Prosthetic limb
timeFrame: Ten months
Secondary outcomes:
measure: Investigate the perceptions of limb movement
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Lerner Research Institute
state: Ohio
city: Edmonton
country: Canada
facility: University of Alberta Glenrose Rehabilitation Hospital
state: Alberta
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland Clinic Lerner Research Institute
name: Paul Marasco, PhD
role: PRINCIPAL_INVESTIGATOR
References: