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NCT03135847 Clinical Trial

Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

Amputation Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03135847
Other study ID # 16-140
Secondary ID W81XWH-15-1-0575
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date June 1, 2024

Study information
Verified date June 2023
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 180
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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. -

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (6)
Lead Sponsor Collaborator
The Cleveland Clinic Congressionally Directed Medical Research Programs, HDT Robotics, Louis Stokes VA Medical Center, United States Department of Defense, University of Alberta

Outcome
Type Measure Description Time frame Safety issue
Primary Skin or tendon location Locations in the skin or muscle of the residual where percepts of touch or movement occur. 36 months
Secondary Sorting Task Performance on a sorting task with and without tactor feedback. 36 months
Secondary Sense of Agency Questionnaire Agreement with statements of agency and ownership related to perceptions of limb movement including unstructured self-reports. 36 months
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