Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961072
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-05-30
Brief Title:
Vibrotactile Stimulation With Saphenus Device
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Vibrotactile Stimulation for Improved Gait and Pain After Major Lower Extremity Amputation Using a Non-invasive Vibration Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
To determine the benefit of the vvibrotactile sensory feedback device
Detailed Description:
In the United States approximately 150000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None