The Effectiveness of Anti-Gravity Treadmill Training

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Lumbar Degenerative Disc Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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AlterG and Physical therapy

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

AlterG

Intervention Type 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

Control group

1\) Standard postoperative rehabilitation program

AlterG

Intervention Type 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

Interventions

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AlterG

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No