The Effectiveness of Anti-Gravity Treadmill Training

NCT01689922 | Terminated

• 1 other identifier: JPNI-2
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Questionnaire

  10 points or 20% improvement on Oswestry Disability Questionnaire

  24 months

Secondary Outcomes (1)

• Patient Global Outcome Ratings and Health Quality Improvement

  24 months

Study Arms (2)

AlterG and Physical therapy

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

Other: AlterG

Control group

1\) Standard postoperative rehabilitation program

Other: AlterG

Interventions

AlterG OTHER

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

AlterG and Physical therapy; Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing one-level microdiscectomy or fusion surgeries

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Justin Parker Neurological Institute: lead

Study Sites (1)

Boulder Neurosurgical Associates

Boulder, Colorado, 80304, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Alan T Villavicencio, MD

  Boulder Neurosurgical Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: September 21, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

US (1)