Recruiting

Observational Study

Sponsor:

Texas Back Institute

Code:

NCT02761265

Conditions

Spinal Curvatures

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

Interventions

Surgical intervention

None (Asymptomatic group)

Study Details

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.

Conditions

Spinal Curvatures

Study ID

NCT02761265

Start date

Mar, 2016

Status verified date

May, 2016

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Surgical Group

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

other: Control Group

Gait and balance testing to be administered once in healthy subjects

Interventions

Surgical intervention

Surgery to correct spinal deformity

None (Asymptomatic group)

Gait and balance testing performed, no treatment in this asymptomatic group

Primary outcome measure

  • Kinematic Variables Change assessed with human motion capture system [ Time Frame: 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 ]
  • Electromyography Variables Change assessed with an Electromyograph [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Ram Haddas, PhD

972-943-2730rhaddas@texas.com

Locations

Texas Back Institute

Recruiting

Plano, Texas, United States, 75093

Contacts

Ram Haddas, PhD

972-943-2730rhaddas@texasback.com

More Information

Sponsor

Texas Back Institute

Last update posted

May 4, 2016

Last verified

May, 2016

Keywords

  • Degenerative Adult Scoliosis
  • Gait Analysis
  • Balance Analysis
  • Biomechanics
  • Neuromuscular Control
  • Thoracolumbar Deformity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Back Institute on 2016-05-04.