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
• 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
• 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).

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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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Related Conditions & MeSH terms

• Amputation
• Prosthesis User

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