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Clinical Trials/NCT03135847
NCT03135847
Enrolling by Invitation
N/A

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

The Cleveland Clinic0 sites180 target enrollmentJune 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prosthesis User
Sponsor
The Cleveland Clinic
Enrollment
180
Primary Endpoint
Skin or tendon location
Status
Enrolling by Invitation
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
June 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul Marasco

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

Time Frame: 36 months

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

Secondary Outcomes

  • Sorting Task(36 months)
  • Sense of Agency Questionnaire(36 months)

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