The Effectiveness of Anti-Gravity Treadmill Training

J

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

Trial design

27 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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