The Effectiveness of Anti-Gravity Treadmill Training

Justin Parker Neurological Institute

Status

Terminated

Conditions

Lumbar Degenerative Disc Disease

Treatments

Other: AlterG

Study type

Observational

Funder types

Other

Identifiers

NCT01689922

JPNI-2

Details and patient eligibility

About

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.

Full 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:

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

Enrollment

27 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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