Recruiting

PT

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06202443

Conditions

Cervical Spine Degeneration

ACDF Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Early PT

Delayed PT

Study Details

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.

Conditions

Cervical Spine Degeneration

ACDF Surgery

Study ID

NCT06202443

Start date

Feb 1, 2024

Status verified date

Aug, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Surgical treatment of a cervical degenerative condition using a 1- or 2-level ACDF procedure;
  • English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
  • Age 18-75 years of age (individuals older than 75 are more likely to experience respiratory and nervous system complications and death following ACDF)

Exclusion Criteria:

  • Surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
  • Undergoing cervical corpectomy;
  • Prior history of cervical spine surgery in last 5 years;
  • Diagnosis or presence of osteoporosis;
  • Diagnosis or presence of severe psychiatric disorder such as schizophrenia or bipolar disorder;
  • Documented history of alcohol and/or drug abuse;
  • Currently involved in litigation due to injury;
  • Currently undergoing treatment for cancer;
  • Patients not able to return for follow-up visits due to time and travel limitation or other reasons; and
  • Unable to provide a stable telephone or physical address

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early Physical Therapy (PT)

PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 2 weeks after hospital discharge

active comparator: Delayed Physical Therapy (PT)

PT will be delivered two times a week for 8 weeks by a licensed physical therapist. Participants will start PT approximately 3 months after hospital discharge.

Interventions

Early PT

Physical therapy delivered within the first three months after surgery.

Delayed PT

Physical therapy delivered greater than 3 months after surgery.

Primary outcome measure

  • Disability [ Time Frame: 6 and 12 months after hospital discharge ]

Central Contacts and Locations

Central contacts

Amanda Priest

615-421-8336amanda.priest@vumc.org

Locations

Tripler Army Medical Center

Recruiting

Honolulu, Hawaii, United States, 96859

Contacts

Rachel Mayhew

206-450-0075rmayhew@genevausa.org

Principal Investigator:

Daniel Rhon, PhD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Amanda Priest

615-421-8336amanda.priest@vumc.org

Booke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Rachel Meyhew

206-450-0075rmayhew@genevausa.org

Principal Investigator:

Daniel Rhon, PhD

Madigan Army Medical Center

Recruiting

Tacoma, Washington, United States, 98431

Contacts

Rachel Mayhew

206-450-0075rmayhew@genevausa.org

Principal Investigator:

Daniel Rhon, PhD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Feb 27, 2026

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-02-27.