Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078507
Status:
COMPLETED
Last Update Posted:
2010-02-03
First Post:
2004-03-01
Brief Title:
Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Sensory Re-Training Following Orthognathic Surgery
Status:
COMPLETED
Status Verified Date:
2010-02
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:
The purpose of this study is to determine whether facial exercises in conjunction with opening exercises routinely provided after facial surgery to correct a facial skeletal disharmony will shorten the time until a patient receives no unpleasant or negative facial sensation
Detailed Description:
Abnormal facial sensation has a negative impact on patients oral behaviors and may adversely affect a patients quality of life if the altered sensation persists Many patients with abnormal sensations retain some sensory function and do not develop chronic pain and for those individuals there are currently no evidence-based noninvasive therapies The goal of this project is to evaluate sensory re-training a rehabilitative therapy that offers significant potential for patients who experience impaired sensory function regardless of the cause This behavioral therapy approach has been used with substantial clinical success with hand injury patients since the 1970s Re-training appears to enhance central reorganization of impulses from an injured sensory nerve to the cerebral cortex so that the altered sensory signals can be interpreted and translated into functionally meaningful motor functions
Sensory re-training will be compared to a placebo jaw-opening exercise in a single blind randomized two-arm parallel group stratified block clinical trial using orthognathic surgery patients as subjects Orthognathic surgery patients offer an uncompromised model for the evaluation of new rehabilitative therapies These healthy individuals treated to correct dentofacial deformity present for surgery with no neurosensory impairment but yet routinely experience substantial alterations in facial sensation following the surgical procedure The effects of sensory re-training will be evaluated using three types of outcomes patient-centered measures to assess the magnitude of the negative effect of altered sensation after surgery and the recovery time needed to reach little or no negative effect neurosensory behavior measures to assess the patients ability to learn alternate cues for touch perception and discrimination and a conventional neurosensory contact threshold measure to assess the actual deficit Our primary focus will be on the patients perception of the negative impact of altered sensation on daily life
Sensory re-training will be compared to a placebo jaw-opening exercise in a single blind randomized two-arm parallel group stratified block clinical trial using orthognathic surgery patients as subjects Orthognathic surgery patients offer an uncompromised model for the evaluation of new rehabilitative therapies These healthy individuals treated to correct dentofacial deformity present for surgery with no neurosensory impairment but yet routinely experience substantial alterations in facial sensation following the surgical procedure The effects of sensory re-training will be evaluated using three types of outcomes patient-centered measures to assess the magnitude of the negative effect of altered sensation after surgery and the recovery time needed to reach little or no negative effect neurosensory behavior measures to assess the patients ability to learn alternate cues for touch perception and discrimination and a conventional neurosensory contact threshold measure to assess the actual deficit Our primary focus will be on the patients perception of the negative impact of altered sensation on daily life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DE013967 | NIH | None | httpsreporternihgovquickSearchR01DE013967 |