The Effectiveness of Anti-Gravity Treadmill Training | NCT01689922

Studies
The Effectiveness of Anti-Gravity Treadmill Training

NCT01689922

Sponsor

Justin Parker Neurological Institute

Status

Terminated

Last Update Posted

Mar 1, 2017Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Lumbar Degenerative Disc Disease

Interventions

AlterG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow enrollment

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jun 12, 2012

First Submission Date that Met QC Criteria

Sep 18, 2012

First Posted Date

Sep 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oswestry Disability Questionnaire	10 points or 20% improvement on Oswestry Disability Questionnaire	24 months

Secondary Outcomes

Measure	Description	Time Frame
Patient Global Outcome Ratings and Health Quality Improvement		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing one-level microdiscectomy or fusion surgeries

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan T Villavicencio, MD	Boulder Neurosurgical Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boulder Neurosurgical Associates		Boulder	Colorado	80304	United States

Condition Browse Module

MeSH Terms

ID	Term
D055959	Intervertebral Disc Degeneration

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided