Suspended

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

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What is being collected

Data Collection

+ other Data

Collected from today forward - Prospective
Other
Who is being recruted

Bone Diseases+1

+ Musculoskeletal Diseases

+ Spinal Diseases

From 18 to 65 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: June 2012
See protocol details

Summary

Principal SponsorJustin Parker Neurological Institute
Last updated: March 1, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01689922
Principal SponsorJustin Parker Neurological Institute
Last updated: March 1, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

27 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesMusculoskeletal DiseasesSpinal DiseasesIntervertebral Disc Degeneration

Criteria

4 inclusion criteria required to participate
Adults between 18 and 65 years old
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 comply with protocol and PT requirements
Willing and able to sign a study specific informed consent
6 exclusion criteria prevent from participating
Active local or systemic infection
Any ongoing health condition that would make it difficult to adhere to postoperative PT requirements
BMI greater than 40
No previous lumbar surgery
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Boulder Neurosurgical Associates

Boulder, United StatesOpen Boulder Neurosurgical Associates in Google Maps
SuspendedOne Study Center