Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202443
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-12-28
Brief Title:
Improving Surgical Outcomes With Early PT After ACDF
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The goal of this two-group randomized clinical trial is to examine the effects of early postoperative PT compared to delayed postoperative PT for improving outcomes after hospital discharge for ACDF surgery
The main question this clinical trial aims to answer are
Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants
Whether improvements in handgrip strength cervical endurance and cervical range of motion will be associated with improvements in outcomes
Participants will be randomized to one of two groups early PT or delayed PT and outcomes compared across groups
The main question this clinical trial aims to answer are
Whether early PT participants will demonstrate greater improvements in outcomes compared to delayed PT participants
Whether improvements in handgrip strength cervical endurance and cervical range of motion will be associated with improvements in outcomes
Participants will be randomized to one of two groups early PT or delayed PT and outcomes compared across groups
Detailed Description:
This study is a prospective randomized controlled trial of early PT within 3 months after surgery versus delayed PT greater than 3 months after surgery in adults following ACDF surgery for degenerative conditions The central hypothesis is that an early PT program will be effective in improving disability pain physical function opioid use and return to workduty 76 participants will be enrolled and randomized 38 patients per randomized group with 64 85 expected to be retained in the trial at the 12-month follow-up Eligible patients undergoing ACDF surgery for a degenerative condition will be randomized to one of two groups early PT or delayed PT Patients will be enrolled prior to surgery asked to complete a preoperative questionnaire prior to surgery and then randomized Patients randomized to one of the PT groups will have their first PT visit scheduled for them by study staff prior to surgery This visit will occur at approximately 2 weeks after hospital discharge for the early PT group and approximately 3 months after hospital discharge for the delayed PT group All randomized patients will be asked to participate in follow-up visits approximately 3- 6- and 12-months after hospital discharge
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