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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02189031
Other study ID # 11061-H39
Secondary ID R01NS081710-01
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 2013
Est. completion date September 2024

Study information

Verified date March 2023
Source Louis Stokes VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 49
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Tactor array

Bypass Tactor


Locations

Country Name City State
Canada University of Alberta Glenrose Rehabilitation Hospital Edmonton Alberta
United States Rehabilitation Institute of Chicago Chicago Illinois
United States Cleveland Clinic Lerner Research Institute Cleveland Ohio
United States Louis Stokes VA Medical Center Cleveland Ohio

Sponsors (8)

Lead Sponsor Collaborator
Louis Stokes VA Medical Center Defense Advanced Research Projects Agency, HDT Global, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Shirley Ryan AbilityLab, The Cleveland Clinic, University of Alberta

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Investigate the perceptions of limb movement 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. 6 months
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External Links