Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160336
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2023-11-29
Brief Title:
Transcutaneous Electrical Stimulation in Lower Limb Amputees
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Use of Transcutaneous Electrical Stimulation for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None