Clinical Trials Logo

Clinical Trial Summary

Current lower limb prostheses support ambulation by absorbing and stabilizing positions during walking. Users of lower limb prostheses rely solely on sensory information provided by the contact between the socket and the residual limb. Restoring sensory feedback could potentially improve their quality of life and participation in daily activities. Despite a high incidence of lower limb amputations, there are few studies in the literature addressing the restoration of sensory feedback in lower limb amputees, particularly studies utilizing invasive techniques. In an effort to overcome these limitations, various non-invasive methods have been tested. Despite resulting benefits such as improved gait symmetry and stability, most non-invasive stimulation systems are non-somatotopic, failing to generate a sensation referred to the patient's missing limb. From the literature, Transcutaneous Electrical Nerve Stimulation (TENS) emerges as a very promising non-invasive and somatotopically-based sensory feedback approach, capable of inducing sensations referred to the amputees' phantom limb. Therefore, the proposed study will involve the use of TENS as a means to stimulate sensitivity and prevent perceptual disturbances associated with the interruption of peripheral nerve structures occurring in individuals undergoing amputation. These disturbances, besides influencing the development of symptoms characterized by neuropathic pain, can impact prosthesis management.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06160336
Study type Interventional
Source Fondazione Don Carlo Gnocchi Onlus
Contact
Status Completed
Phase N/A
Start date March 14, 2021
Completion date August 4, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04275973 - Evaluating Mobility Interventions in the Real World N/A
Completed NCT01946321 - Outcome Measures for Lower Limb Amputees - A Rehabilitation Study N/A
Completed NCT01953939 - Outcome Measures for Lower Limb Amputees - A Repeatability Study N/A
Recruiting NCT04030650 - Study of Locomotor Expectations for Ascending/Descending Slope and Stairs in Patients With Limb Amputations
Completed NCT04141748 - Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit N/A
Enrolling by invitation NCT05807607 - Study of Lower-limb Phantom Pain Syndrome Using Peripheral Nerve and Spinal Cord Stimulation N/A
Recruiting NCT03260530 - Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis
Completed NCT03409354 - Tele-Rehabilitation Pilot Evaluation Study N/A
Recruiting NCT05830630 - Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery N/A
Recruiting NCT01846845 - Evaluation of a Novel Transfemoral Prosthetic Socket System N/A
Recruiting NCT05880251 - Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation N/A
Completed NCT04285138 - Phantom Exercise for Lower Limb Amputees N/A
Completed NCT01715662 - A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation N/A
Withdrawn NCT04086069 - Sit-to-stand Trainer in Patients After Lower Limb Amputation N/A
Completed NCT04293237 - Metric Charcteristics of Sit-to-stand Tests in Patients After Lower-limb Amputation
Recruiting NCT06276179 - Epidural Oxycodone for Pain Management for Lower Limb Amputation N/A
Not yet recruiting NCT01748435 - Pre-emptive Analgesia With Qutenza in Lower Limb Amputation N/A
Completed NCT05224232 - Protocole Access-Socket N/A
Completed NCT03927404 - Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health N/A
Terminated NCT02572011 - Transtibial Amputee Balance Training: A Randomised Controlled Trial N/A