Gait and Balance in Thoracolumbar Spinal Deformity

May 2, 2016 updated by: Ram Haddas, Texas Back Institute

The Effect of Thoracolumbar Spinal Deformity and Its Surgical Correction on Gait and Balance in Adults

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical Group
Gait and balance testing as well as self-reported outcome assessments to be administered before and after surgery
Procedure: Surgical intervention
Surgery to correct spinal deformity
Other: Control Group
Gait and balance testing to be administered once in healthy subjects
Other: None (Asymptomatic group)
Gait and balance testing performed, no treatment in this asymptomatic group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinematic Variables Change assessed with human motion capture system
Time Frame: Prior to surgery; 3 and 12 months after surgery
3-Dimensional Range of Motion (ROM) during the stance and swing phase.
Prior to surgery; 3 and 12 months after surgery
Kinetic Variables Change assessed with human motion capture system
Time Frame: Prior to surgery; 3 and 12 months after surgery
Vertical Ground Reaction Forces (GRF)
Prior to surgery; 3 and 12 months after surgery
Electromyography Variables Change assessed with an Electromyograph
Time Frame: Prior to surgery; 3 and 12 months after surgery
Bilateral peak magnitude during the stance phase
Prior to surgery; 3 and 12 months after surgery
Spatio-Temporal Variables Change assessed with human motion capture system
Time Frame: Prior to surgery; 3 and 12 months after surgery
Walking Speed
Prior to surgery; 3 and 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Self-Reported Outcome Assessments Change
Time Frame: Prior to surgery; 3 and 12 months after surgery
Visual Analog Scale (VAS)
Prior to surgery; 3 and 12 months after surgery
Patient Self-Reported Outcome Assessments Change
Time Frame: Prior to surgery; 3 and 12 months after surgery
Scoliosis Research Society (SRS) -22
Prior to surgery; 3 and 12 months after surgery
Patient Self-Reported Outcome Assessments Change
Time Frame: Prior to surgery; 3 and 12 months after surgery
Neck Disability Index (NDI)
Prior to surgery; 3 and 12 months after surgery
Patient Self-Reported Outcome Assessments Change
Time Frame: Prior to surgery; 3 and 12 months after surgery
Oswestry Disability Index (ODI)
Prior to surgery; 3 and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Back Institute

Collaborators

Alphatec Spine, Inc.

Investigators

  • Principal Investigator: Ram Haddas, PhD, Texas Back Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBIRF-SBL-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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