Sensory Feedback for Touch and Proprioception With Prosthetic Limbs

• Conditions: Prosthetic
• Interventions: Device: Bypass Tactor; Device: Tactor array

• Registration Number: NCT02189031
• Lead Sponsor: Louis Stokes VA Medical Center

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 49

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Able Bodied	Bypass Tactor	Bypass tactor
Upper Extremity Amputee	Tactor array	Robust custom tactor to facilitate embodiment and proprioception

Primary Outcome Measures

Name	Time	Method
Embodiment of the Prosthetic limb	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.

Secondary Outcome Measures

Name	Time	Method
Investigate the perceptions of limb movement	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.

Trial Locations

Locations (4)

Cleveland Clinic Lerner Research Institute; 🇺🇸 Cleveland, Ohio, United States

University of Alberta Glenrose Rehabilitation Hospital; 🇨🇦 Edmonton, Alberta, Canada

Rehabilitation Institute of Chicago; 🇺🇸 Chicago, Illinois, United States

Louis Stokes VA Medical Center; 🇺🇸 Cleveland, Ohio, United States