Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06202443
Status
Recruiting

Conditions

  • ACDF Surgery
  • Cervical Spine Degeneration

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Early PT — OTHER
    Physical therapy delivered within the first three months after surgery.
  • Delayed PT — OTHER
    Physical therapy delivered greater than 3 months after surgery.

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Tripler Army Medical CenterHonoluluHawaii96859
Rachel Mayhew
206-450-0075
Daniel Rhon, PhD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37203
Amanda Priest
615-421-8336
Booke Army Medical CenterFort Sam HoustonTexas78234
Rachel Meyhew
206-450-0075
Daniel Rhon, PhD (PRINCIPAL_INVESTIGATOR)
Madigan Army Medical CenterTacomaWashington98431
Rachel Mayhew
206-450-0075
Daniel Rhon, PhD (PRINCIPAL_INVESTIGATOR)

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