NCT03033212

Single-Level TLIF: Post-Fusion Rehabilitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This investigation will assess how the timing and type of rehabilitation after a transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure. The efficacy of the procedure will be evaluated through patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure. These measures will be compared to the patients' baseline value.

Detailed description

Patients will undergo transforaminal lumbar interbody fusion for degenerative pathology at the L4-5 vertebral level. They will be randomized to one of three postoperative rehabilitation groups. Group 1 will receive "structured early rehabilitation" beginning at 7 weeks. Group 2 will receive "Delayed rehabilitation" beginning at 13 weeks postoperatively. Group 3 will undergo "Self Rehabilitation" beginning at 7 weeks postoperatively. Groups 1 and 2 will undergo rehabilitation under the supervision of a certified physical therapist for 10 total weeks. Group 3 will undergo non-supervised rehabilitation for 10 total weeks, and will be given educational materials regarding which exercises to perform and at which intervals.

Conditions

• Degenerative Spinal Cord Disease

Interventions

Type	Name	Description
OTHER	Therapist-Guided Rehabilitation	Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
OTHER	Self-Guided Rehabilitation	Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.

Timeline

• Start date: 2017-08-21
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2017-01-26
• Last updated: 2021-09-16

Locations

1 site across 1 country: United States