Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

N/AEnrolling By InvitationNCT03135847

The Cleveland Clinic180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

180

Conditions

Prosthesis User Amputation

Interventions

TactorDEVICE

The tactor is a small robot providing touch and vibration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. \-

Outcomes

Primary Outcomes

Skin or tendon location

Locations in the skin or muscle of the residual where percepts of touch or movement occur.

Time frame: 36 months

Secondary Outcomes

Sorting Task

Performance on a sorting task with and without tactor feedback.

Time frame: 36 months

Sense of Agency Questionnaire

Agreement with statements of agency and ownership related to perceptions of limb movement including unstructured self-reports.

Time frame: 36 months

Data from ClinicalTrials.gov

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