RECRUITING

Improving Surgical Outcomes With Early PT After ACDF

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improving Surgical Outcomes With Early Physical Therapy After Anterior Cervical Discectomy and Fusion

Quick Facts

Study Start:2024-02-01
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06202443

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure;
  2. * English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
  3. * Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF)
  1. * Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
  2. * Undergoing cervical corpectomy;
  3. * Prior history of cervical spine surgery in last 5 years;
  4. * Diagnosis or presence of osteoporosis;
  5. * Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder;
  6. * Documented history of alcohol and/or drug abuse;
  7. * Currently involved in litigation due to injury;
  8. * Currently undergoing treatment for cancer;
  9. * Patients not able to return for follow-up visits due to time and travel limitation or other reasons; and
  10. * Unable to provide a stable telephone or physical address

Contacts and Locations

Study Contact

Amanda Priest
CONTACT
615-421-8336
amanda.priest@vumc.org

Principal Investigator

Kristin Archer, PhD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37203
United States
Booke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Madigan Army Medical Center
Tacoma, Washington, 98431
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Kristin Archer, PhD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2024-02-01
Study Completion Date2027-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cervical Spine Degeneration
  • ACDF Surgery