Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

NCT ID: NCT03135847

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Prosthesis User Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Amputee and Able Bodied Subjects

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.

Group Type EXPERIMENTAL

Tactor

Intervention Type DEVICE

The tactor is a small robot providing touch and vibration.

Interventions

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Tactor

The tactor is a small robot providing touch and vibration.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Louis Stokes VA Medical Center

FED

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

HDT Robotics

UNKNOWN

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

Congressionally Directed Medical Research Programs

FED

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Paul Marasco

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Marasco, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Other Identifiers

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W81XWH-15-1-0575

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

16-140

Identifier Type: -

Identifier Source: org_study_id

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