The Effectiveness of Anti-Gravity Treadmill Training

The Effectiveness of Anti-Gravity Treadmill Training in Patients After Lumbar Microdiscectomy and Fusion Surgeries

The primary objective of this study is to compare the effectiveness of standard for our practice postoperative physical therapy (PT) program to a PT program that incorporates lower body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and fusion surgeries.

Study Overview

• Status: Terminated
• Conditions: Lumbar Degenerative Disc Disease
• Intervention / Treatment: Other: AlterG

Detailed Description

A prospective, randomized, parallel group controlled clinical study is proposed. The patients will be divided into the two study groups according to the surgical procedure:

1. patients undergoing one-level microdiscectomy for lumbar herniated disc
2. patients undergoing one-level lumbar fusion for degenerative disc disease without notable spinal stenosis.

Each group will consist of 60 patients (see sample size calculations below) who will be randomized into the two equal groups to undergo:

1. Standard postoperative rehabilitation program
2. Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Boulder Neurosurgical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing one-level microdiscectomy or fusion surgeries

Description

Inclusion Criteria:

• Adults between 18 and 65 years old
• Willing and able to comply with protocol and PT requirements
• Patients with primarily radicular and back pain due to degenerative disc disease requiring one-level discectomy for herniated disc or lumbar fusion between L2 and S1
• Willing and able to sign a study specific informed consent

Exclusion Criteria:

• Require more than one-level surgery
• No previous lumbar surgery
• Any ongoing health condition that would make it difficult to adhere to postoperative PT requirements
• Peri-operative or post-operative complications (infection, pneumonia, nerve injury, dural tear, etc.) that would constraint or delay the ability to participate in postoperative PT
• BMI greater than 40
• Active local or systemic infection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AlterG and Physical therapy; 2) Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training	Other: AlterG; All patients will begin an early postoperative rehabilitation program and standard PT no later than 4 weeks following surgery and continue for at least 6 weeks. The duration of standard PT program could be extended depending on the patient needs. The patients randomized to undergo (LBPP) treadmill training will have an additional 7-week 3 times a week training on the antigravity
Control group; 1) Standard postoperative rehabilitation program	Other: AlterG; All patients will begin an early postoperative rehabilitation program and standard PT no later than 4 weeks following surgery and continue for at least 6 weeks. The duration of standard PT program could be extended depending on the patient needs. The patients randomized to undergo (LBPP) treadmill training will have an additional 7-week 3 times a week training on the antigravity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Questionnaire	10 points or 20% improvement on Oswestry Disability Questionnaire	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient Global Outcome Ratings and Health Quality Improvement	24 months

Collaborators and Investigators

• Sponsor: Justin Parker Neurological Institute
• Investigators: Principal Investigator: Alan T Villavicencio, MD, Boulder Neurosurgical Associates

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: JPNI-2