Prosthetic Limb Movement Feedback for Upper and Lower Extremity Amputees

Not Applicable

• Conditions: Amputation; Prosthesis User
• Interventions: Device: Tactor

• Registration Number: NCT03135847
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amputee and Able Bodied Subjects	Tactor	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Sorting Task	36 months	Performance on a sorting task with and without tactor feedback.
Sense of Agency Questionnaire	36 months	Agreement with statements of agency and ownership related to perceptions of limb movement including unstructured self-reports.