Gait and Balance in Thoracolumbar Spinal Deformity

NCT02761265 | Unknown

• 1 other identifier: TBIRF-SBL-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Kinematic Variables Change assessed with human motion capture system

  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

  Vertical Ground Reaction Forces (GRF)

  Prior to surgery; 3 and 12 months after surgery

• Electromyography Variables Change assessed with an Electromyograph

  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

  Walking Speed

  Prior to surgery; 3 and 12 months after surgery

Secondary Outcomes (4)

• Patient Self-Reported Outcome Assessments Change

  Prior to surgery; 3 and 12 months after surgery

• Patient Self-Reported Outcome Assessments Change

  Prior to surgery; 3 and 12 months after surgery

• Patient Self-Reported Outcome Assessments Change

  Prior to surgery; 3 and 12 months after surgery

• Patient Self-Reported Outcome Assessments Change

  Prior to surgery; 3 and 12 months after surgery

Study Arms (2)

Surgical Group

EXPERIMENTAL

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

Procedure: Surgical intervention

Control Group

OTHER

Gait and balance testing to be administered once in healthy subjects

Other: None (Asymptomatic group)

Interventions

Surgical intervention PROCEDURE

Surgery to correct spinal deformity

Surgical Group

None (Asymptomatic group) OTHER

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

Control Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Back Institute: lead
• Alphatec Spine, Inc.: collaborator

Study Sites (1)

Texas Back Institute

Plano, Texas, 75093, United States

RECRUITING

Related Publications (26)

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  PMID: 23024623 BACKGROUND

• Kotwicki T, Chowanska J, Kinel E, Czaprowski D, Tomaszewski M, Janusz P. Optimal management of idiopathic scoliosis in adolescence. Adolesc Health Med Ther. 2013 Jul 23;4:59-73. doi: 10.2147/AHMT.S32088. eCollection 2013.

  PMID: 24600296 BACKGROUND

• Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28.

  PMID: 17630141 BACKGROUND

• Engsberg JR, Bridwell KH, Reitenbach AK, Uhrich ML, Baldus C, Blanke K, Lenke LG. Preoperative gait comparisons between adults undergoing long spinal deformity fusion surgery (thoracic to L4, L5, or sacrum) and controls. Spine (Phila Pa 1976). 2001 Sep 15;26(18):2020-8. doi: 10.1097/00007632-200109150-00016.

  PMID: 11547203 BACKGROUND

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  PMID: 19224255 BACKGROUND

• Arima H, Yamato Y, Hasegawa T, et al. Gait analysis after corrective surgery for adult spinal deformity - good sagittal balance with improved lumber lordosis is important. Scoliosis. 2015;10(Suppl 1):O76.

  BACKGROUND

• Kramers-de Quervain IA, Muller R, Stacoff A, Grob D, Stussi E. Gait analysis in patients with idiopathic scoliosis. Eur Spine J. 2004 Aug;13(5):449-56. doi: 10.1007/s00586-003-0588-x. Epub 2004 Apr 3.

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  PMID: 15221574 BACKGROUND

• Giakas G, Baltzopoulos V, Dangerfield PH, Dorgan JC, Dalmira S. Comparison of gait patterns between healthy and scoliotic patients using time and frequency domain analysis of ground reaction forces. Spine (Phila Pa 1976). 1996 Oct 1;21(19):2235-42. doi: 10.1097/00007632-199610010-00011.

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  BACKGROUND

• Schwab F, Ungar B, Blondel B, Buchowski J, Coe J, Deinlein D, DeWald C, Mehdian H, Shaffrey C, Tribus C, Lafage V. Scoliosis Research Society-Schwab adult spinal deformity classification: a validation study. Spine (Phila Pa 1976). 2012 May 20;37(12):1077-82. doi: 10.1097/BRS.0b013e31823e15e2.

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  PMID: 15990669 BACKGROUND

• Vaughan CL, Davis BL, O'Conner JC. Dynamics of Human Gait. 2nd ed. Cape Town, South Africa: Kiboho Publishers; 1999.

  BACKGROUND

• Arumugam A, Milosavljevic S, Woodley S, Sole G. Effects of external pelvic compression on form closure, force closure, and neuromotor control of the lumbopelvic spine--a systematic review. Man Ther. 2012 Aug;17(4):275-84. doi: 10.1016/j.math.2012.01.010. Epub 2012 Mar 2.

  PMID: 22386280 BACKGROUND

MeSH Terms

Conditions

Spinal Curvatures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ram Haddas, PhD

  Texas Back Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ram Haddas, PhD

CONTACT

972-943-2730; rhaddas@texas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 4, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 4, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)