Clinical Trials Logo

Clinical Trial Summary

To determine the benefit of the vvibrotactile sensory feedback device.


Clinical Trial Description

In the United States, approximately 150.000 patients undergo a lower extremity amputation annually. With a high change of developing neuropathic pain, decreased mobility due to the missing limb and therefore depressed mental wellbeing, lower extremity amputations are debilitating the patient on multiple facets. From the usage of non-mechanical prosthetic wear, meaningful improvements have been made in surgical amputee care in the recent decades. Osseointegration, and later regenerative nerve surgical techniques like targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI) have led to major improvements in the mobility of lower limb amputees, by introducing myoeletric prosthetics. Although technological advances have let to improved motoric function and motor control over artificial limbs, sensory feedback is still a very complex aspect of regaining full control over the missing limb. Recently, introduced as a technical variation on TMR, Targeted Sensory Reinnervation is based on reinnervation of a defined skin area by another sensory nerve. Recently, application of vibrotactile feedback, connected to the lower extremity prosthetic socket, has shown promising results in regaining proprioception in the missing limb, resulting in improved walking ability and pain. However, Targeted Sensory Reinnervation (TSR) is a novel surgical technique which is not always possible to perform and not available to every lower extremity amputee. Therefore, this study aims to investigate whether this vibrotactile sensory feedback device improves gait and pain in major lower limb amputee population regardless of whether TSR has been conducted. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05961072
Study type Interventional
Source Massachusetts General Hospital
Contact Kyle R Eberlin, MD
Phone (617) 643-4902
Email keberlin@mgh.harvard.edu
Status Not yet recruiting
Phase N/A
Start date August 1, 2023
Completion date May 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03947450 - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees Phase 2
Completed NCT04924036 - Qbrexza Cloths for Hyperhidrosis of Amputation Sites Phase 2
Recruiting NCT04839497 - Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees. Phase 2
Recruiting NCT04212299 - Transfemoral Socket Design and Muscle Function N/A
Completed NCT03733054 - Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
Completed NCT03651830 - A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations N/A
Recruiting NCT04725006 - Sensory Responses to Dorsal Root Stimulation N/A
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT04936789 - Clinical Feasibility of the IMES Transradial Prosthesis N/A
Completed NCT01155024 - Clinical Evaluation of Direct Manufactured Prosthetic Sockets Phase 2
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Terminated NCT00778856 - Hand Transplantation for the Reconstruction of Below the Elbow Amputations N/A
Recruiting NCT00388752 - Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation Phase 1
Active, not recruiting NCT03374319 - Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations N/A
Completed NCT05542901 - Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees N/A
Completed NCT05161364 - Kinetic Analysis Due to Foot Dysfunction
Recruiting NCT06194838 - Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees N/A
Completed NCT03570788 - HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
Completed NCT05778799 - Physical Activity and Sports for People With Special Needs
Recruiting NCT04804150 - Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System N/A