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Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

Sponsor
The Cleveland Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03135847
Collaborator
Louis Stokes VA Medical Center (U.S. Fed), University of Alberta (Other), HDT Robotics (Other), United States Department of Defense (U.S. Fed), Congressionally Directed Medical Research Programs (U.S. Fed)
180
Enrollment
1
Arm
84
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tactor
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Physiologically Relevant Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees
Actual Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Skin or tendon location [36 months]

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

Secondary Outcome Measures

  1. Sorting Task [36 months]

    Performance on a sorting task with and without tactor feedback.

  2. Sense of Agency Questionnaire [36 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Paul Marasco, PhD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paul Marasco, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT03135847
Other Study ID Numbers:
  • 16-140
  • W81XWH-15-1-0575
First Posted:
May 1, 2017
Last Update Posted:
Aug 5, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 5, 2021