Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

NeuroTherapia, Inc.

Status: Invitation-only

Conditions: Amputation; Prosthesis User

Treatments: Device: Tactor

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03135847

16-140

W81XWH-15-1-0575 (Other Grant/Funding Number)

Details and patient eligibility

About

To assess the functional characteristics and utility of upper and lower limb prosthetic devices (advanced bionic and current clinical standard-of-care) that incorporate physiologically relevant touch and/or movement feedback.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria are adults (18 years or over) with major limb amputation (at or above wrist or ankle).

Exclusion criteria

Exclusion criteria are any skin or pain conditions that would preclude ability to withstand pressures on their limb or to wear a prosthetic socket, or cognitive barriers precluding providing informed consent.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

Amputee and Able Bodied Subjects

Experimental group

Description:

Map the locations in the skin or deeper muscle where limb movement perceptions occur. Use tactors (small robots providing touch and vibration) to mechanically provide sensation to the residual muscles in amputees and the intact muscles in able-bodied. The functional experiments will occur concurrently with development and application of new prosthetic socket designs to incorporate control and feedback.

Treatment:

Device: Tactor