Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

Physiologically Relevant Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

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 Overview

• Status: Enrolling by invitation
• Conditions: Amputation; Prosthesis User
• Intervention / Treatment: Device: Tactor

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Tactor; The tactor is a small robot providing touch and vibration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin or tendon location	Locations in the skin or muscle of the residual where percepts of touch or movement occur.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sorting Task	Performance on a sorting task with and without tactor feedback.	36 months
Sense of Agency Questionnaire	Agreement with statements of agency and ownership related to perceptions of limb movement including unstructured self-reports.	36 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: United States Department of Defense; University of Alberta; Louis Stokes VA Medical Center; Congressionally Directed Medical Research Programs; HDT Robotics
• Investigators: Principal Investigator: Paul Marasco, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 16-140; W81XWH-15-1-0575 (Other Grant/Funding Number: Congressionally Directed Medical Research Programs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Significant scientific results and data will be shared. Final data sets will include information such as survey results, de-identified aggregate data of prosthetic users' abilities and functional outcomes, de-identified photographic/video. Non-proprietary/non-identifying data and findings will be disseminated in a timely manner through scientific seminars, meetings, and peer reviewed publications.
• IPD Sharing Time Frame: Data will be shared within the 4-year time frame following the end of active protocols.
• IPD Sharing Access Criteria: Data will be shared under the auspices of the principal investigator and data sharing will be done through a Cleveland Clinic issued, firewall protected FTP network server. Although the final data set will be stripped of identifiers, the possibility of deductive disclosure remains. Data/documentation will be available only under data-sharing agreements that provide for: (1) a commitment to data use only for research purposes only and non-identification of individuals; (2) a commitment to data security with using appropriate technology; and (3) a commitment to destroying/returning data after completed analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No