Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

NCT03135847 | Enrolling By Invitation

• 2 other identifiers: 16-140W81XWH-15-1-0575
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prosthesis User; Amputation

Outcome Measures

Primary Outcomes (1)

• Skin or tendon location

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

  36 months

Secondary Outcomes (2)

• Sorting Task

  36 months

• Sense of Agency Questionnaire

  36 months

Study Arms (1)

Amputee and Able Bodied Subjects

EXPERIMENTAL

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

Interventions

Tactor DEVICE

The tactor is a small robot providing touch and vibration.

Amputee and Able Bodied Subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Louis Stokes VA Medical Center: collaborator
• University of Alberta: collaborator
• HDT Robotics: collaborator
• United States Department of Defense: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Officials

• Paul Marasco, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 1, 2017
• Study Start: June 1, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared within the 4-year time frame following the end of active protocols.
• 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.