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 — OTHERPhysical therapy delivered within the first three months after surgery.
- Delayed PT — OTHERPhysical 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
- Amanda Priest615-421-8336
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | Daniel Rhon, PhD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | |
| Booke Army Medical Center | Fort Sam Houston | Texas | 78234 | Daniel Rhon, PhD (PRINCIPAL_INVESTIGATOR) |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | Daniel Rhon, PhD (PRINCIPAL_INVESTIGATOR) |
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