The Effectiveness of Anti-Gravity Treadmill Training

Study Overview
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Brief Summary
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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.

Detailed Description
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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: patients undergoing one-level microdiscectomy for lumbar herniated disc 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: Standard postoperative rehabilitation program Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training

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

Conditions
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Lumbar Degenerative Disc Disease

Intervention / Treatment
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* Other: AlterG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AlterG and Physical therapy<br>2) Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training | Other: AlterG<br>* 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<br>|
| Control group<br>1) Standard postoperative rehabilitation program | Other: AlterG<br>* 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<br>|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Outcome Ratings and Health Quality Improvement |  | 24 months |