The Effectiveness of Anti-Gravity Treadmill Training

Terminated

• Conditions: Lumbar Degenerative Disc Disease
• Interventions: Other: AlterG

• Registration Number: NCT01689922
• Lead Sponsor: Justin Parker Neurological Institute

Brief Summary

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

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AlterG and Physical therapy	AlterG	2) Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training
Control group	AlterG	1) Standard postoperative rehabilitation program

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Questionnaire	24 months	10 points or 20% improvement on Oswestry Disability Questionnaire

Secondary Outcome Measures

Name	Time	Method
Patient Global Outcome Ratings and Health Quality Improvement	24 months

Trial Locations

Locations (1)

Boulder Neurosurgical Associates; 🇺🇸 Boulder, Colorado, United States