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Gait and Balance in Thoracolumbar Spinal Deformity

Primary Purpose

Spinal Curvatures

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgical intervention
None (Asymptomatic group)
Sponsored by
Texas Back Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Curvatures focused on measuring Degenerative Adult Scoliosis, Gait Analysis, Balance Analysis, Biomechanics, Neuromuscular Control, Thoracolumbar Deformity

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 30 years and older
  2. Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
  3. Instrumentation to be used at 4 or more levels
  4. Able to ambulate without assistance and stand without assistance with participant eyes open for a minimum of 10 seconds
  5. Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-operative follow-up

Exclusion Criteria:

  1. History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion)
  2. Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
  3. BMI higher than 35
  4. Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
  5. Usage of blood thinners
  6. Major trauma to the pelvis
  7. Pregnant or wishing to become pregnant during the study

Sites / Locations

  • Texas Back InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Surgical Group

Control Group

Arm Description

Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery

Gait and balance testing to be administered once in healthy subjects

Outcomes

Primary Outcome Measures

Kinematic Variables Change assessed with human motion capture system
3-Dimensional Range of Motion (ROM) during the stance and swing phase.
Kinetic Variables Change assessed with human motion capture system
Vertical Ground Reaction Forces (GRF)
Electromyography Variables Change assessed with an Electromyograph
Bilateral peak magnitude during the stance phase
Spatio-Temporal Variables Change assessed with human motion capture system
Walking Speed

Secondary Outcome Measures

Patient Self-Reported Outcome Assessments Change
Visual Analog Scale (VAS)
Patient Self-Reported Outcome Assessments Change
Scoliosis Research Society (SRS) -22
Patient Self-Reported Outcome Assessments Change
Neck Disability Index (NDI)
Patient Self-Reported Outcome Assessments Change
Oswestry Disability Index (ODI)

Full Information

First Posted
April 19, 2016
Last Updated
May 2, 2016
Sponsor
Texas Back Institute
Collaborators
Alphatec Spine, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02761265
Brief Title
Gait and Balance in Thoracolumbar Spinal Deformity
Official Title
The Effect of Thoracolumbar Spinal Deformity and Its Surgical Correction on Gait and Balance in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Back Institute
Collaborators
Alphatec Spine, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Based on the investigators knowledge, there is limited literature on biomechanics and neuromuscular control of the lower extremities and spine as assessed by objective gait analysis and balance strategies in adult degenerative scoliosis patients, pre and post surgical intervention. The purpose of this study is to determine the impact of spinal deformity on the biomechanics and neuromuscular control of the lower and upper extremities, and also investigate the impact of surgery on these functions as evaluated by gait and balance analyses using dynamic EMG, video motion capture and force plate analysis and also to compare these patients with healthy controls to better evaluate the extent of limitations before and after surgery.
Detailed Description
Degenerative adult scoliosis results from age related changes leading to segmental instability, deformity and stenosis. Although the etiology is unclear, degenerative adult scoliosis is associated with progressive and asymmetric degeneration of the disc and facet joints, which typically lead to stenosis. By virtue of the narrowed spinal canal associated with the degeneration these patients frequently develop back pain, as well as leg pain, weakness, and numbness. With an aging population in the USA and an increased attention to quality of life versus cost issues in the current healthcare environment, degenerative adult scoliosis has become a considerable healthcare concern. Patients with scoliosis demonstrate an altered gait pattern. Such differences include decreased step length and reduced range of motion in the upper and lower extremities, asymmetry of trunk rotation and ground reaction force in three-dimensions. Mahaudens et al. found a decrease in the muscular mechanical work associated with an increase of energy cost and a decrease in the muscular efficiency in a scoliosis population compared to healthy controls. Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. This altered gait pattern demonstrated by subjects with scoliosis may be due to changes in global postural control strategies caused by spinal deformity. Previous research showed that scoliosis patients do not have impaired postural balance when compared to healthy controls, while several others did find an effect of scoliosis on postural balance. This discrepancy in findings may be due to differences in curve characteristics included and their effects on postural balance, curve types (single or double), number of different curve types, location of curves (thoracic and lumbar), and/or Cobb angles. Furthermore, Schimmel et al. found that postural balance one year after surgery did not improve as a result of the better spinal alignment, neither did the reduced range of trunk motion inherent to fusion negatively affect postural balance. While medicinal interventions may assist with some of the associated co-morbid conditions, surgical interventions may be indicated for those patients with intractable and debilitating low back and leg pain. These surgeries have proven to be extremely successful in a majority of patients. The surgeries may involve decompression and instrumentation to stabilize the spine to achieve arthrodesis. Surgical intervention may provide pain relief and improvement in function but one area of significant clinical interest is the restoration/improvement in gait and functional balance. Based on the investigators knowledge, there is limited literature on biomechanics and neuromuscular control of the lower extremities and spine as assessed by objective gait analysis and balance strategies in adult degenerative scoliosis patients, pre and post surgical intervention. The purpose of this study is to determine the impact of spinal deformity on the biomechanics and neuromuscular control of the lower and upper extremities, and also investigate the impact of surgery on these functions as evaluated by gait and balance analyses using dynamic Electromyograph (EMG), video motion capture and force plate analysis and also to compare these patients with healthy controls to better evaluate the extent of limitations before and after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Curvatures
Keywords
Degenerative Adult Scoliosis, Gait Analysis, Balance Analysis, Biomechanics, Neuromuscular Control, Thoracolumbar Deformity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Group
Arm Type
Experimental
Arm Description
Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery
Arm Title
Control Group
Arm Type
Other
Arm Description
Gait and balance testing to be administered once in healthy subjects
Intervention Type
Procedure
Intervention Name(s)
Surgical intervention
Intervention Description
Surgery to correct spinal deformity
Intervention Type
Other
Intervention Name(s)
None (Asymptomatic group)
Intervention Description
Gait and balance testing performed, no treatment in this asymptomatic group
Primary Outcome Measure Information:
Title
Kinematic Variables Change assessed with human motion capture system
Description
3-Dimensional Range of Motion (ROM) during the stance and swing phase.
Time Frame
Prior to surgery; 3 and 12 months after surgery
Title
Kinetic Variables Change assessed with human motion capture system
Description
Vertical Ground Reaction Forces (GRF)
Time Frame
Prior to surgery; 3 and 12 months after surgery
Title
Electromyography Variables Change assessed with an Electromyograph
Description
Bilateral peak magnitude during the stance phase
Time Frame
Prior to surgery; 3 and 12 months after surgery
Title
Spatio-Temporal Variables Change assessed with human motion capture system
Description
Walking Speed
Time Frame
Prior to surgery; 3 and 12 months after surgery
Secondary Outcome Measure Information:
Title
Patient Self-Reported Outcome Assessments Change
Description
Visual Analog Scale (VAS)
Time Frame
Prior to surgery; 3 and 12 months after surgery
Title
Patient Self-Reported Outcome Assessments Change
Description
Scoliosis Research Society (SRS) -22
Time Frame
Prior to surgery; 3 and 12 months after surgery
Title
Patient Self-Reported Outcome Assessments Change
Description
Neck Disability Index (NDI)
Time Frame
Prior to surgery; 3 and 12 months after surgery
Title
Patient Self-Reported Outcome Assessments Change
Description
Oswestry Disability Index (ODI)
Time Frame
Prior to surgery; 3 and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 30 years and older Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater Instrumentation to be used at 4 or more levels Able to ambulate without assistance and stand without assistance with participant eyes open for a minimum of 10 seconds Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-operative follow-up Exclusion Criteria: History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion) Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion) BMI higher than 35 Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance Usage of blood thinners Major trauma to the pelvis Pregnant or wishing to become pregnant during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ram Haddas, PhD
Phone
972-943-2730
Email
rhaddas@texas.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ram Haddas, PhD
Organizational Affiliation
Texas Back Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ram Haddas, PhD
Phone
972-943-2730
Email
rhaddas@texasback.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Gait and Balance in Thoracolumbar Spinal Deformity

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