Influence of Sagittal Imbalance of the Spine on Gait Pattern in Adult Spinal Deformity

NCT03304405 | Completed

• 1 other identifier: UW 16-294
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to investigate the changes in gait pattern in adult spinal deformity (ASD) patients with sagittal imbalance. It will investigate the gait kinematics in patients who have a mismatch of their spinopelvic parameters, and a positive sagittal balance. The investigators hypothesise that patients with abnormal spinopelvic parameters may demonstrate a pathological gait pattern.

Conditions

Adult Spinal Deformity

Keywords

ASD

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of sagittal imbalance on the gait cycle using reflective surface markers

  To evaluate the effect of sagittal imbalance on the gait cycle using reflective surface markers

  1 year

Secondary Outcomes (3)

• Investigate the difference in gait kinematics between normal and abnormal sagittal balance using reflective surface markers

  1 year

• Investigate the efficiency in gait differences between normal and abnormal sagittal balance using reflective surface markers

  1 year

• Investigate different muscle recruitment in gait cycles between normal and abnormal sagittal balance using a submaximal graded exercise test

  1 year

Study Arms (1)

Gait Analysis

All patients will undergo gait analysis using reflective surface markers placed at different locations on the head, trunk, upper and lower extremities, and pelvis. All patients will complete an analog pain scale, Oswestry, and SRS-22 questionnaires. These are health-related quality of life questionnaires that provide subjective assessment.

Diagnostic Test: Gait Analysis

Interventions

Gait Analysis DIAGNOSTIC_TEST

All patients will undergo gait analysis using reflective surface markers placed at different locations on the head, trunk, upper and lower extremities, and pelvis. All patients will complete an analog pain scale, Oswestry, and SRS-22 questionnaires. These are health-related quality of life questionnaires that provide subjective assessment.

Gait Analysis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of ADS will be recruited in this study conducted by the Department of Orthopaedics and Traumatology.

You may qualify if:

• All patients diagnosed with ASD, fulfilling the following radiographic criteria based on whole spine lateral film are eligible for recruitment:
• SVA bigger than 47mm
• Pelvic tilt (PT) bigger than 22deg
• Pelvic incidence (PI) - lumbar lordosis (LL) bigger than 11deg

You may not qualify if:

• If the aetiology of the ASD of the patient is neuromuscular origin
• other pathologies that may affect their gait such as previous trauma or surgeries to the pelvis or the lower limbs and joint replacements
• inability to walk without aids for short distances

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

Location

Related Publications (11)

• Cho KJ, Suk SI, Park SR, Kim JH, Kang SB, Kim HS, Oh SJ. Risk factors of sagittal decompensation after long posterior instrumentation and fusion for degenerative lumbar scoliosis. Spine (Phila Pa 1976). 2010 Aug 1;35(17):1595-601. doi: 10.1097/BRS.0b013e3181bdad89.

  PMID: 20386505 BACKGROUND

• Glassman SD, Berven S, Bridwell K, Horton W, Dimar JR. Correlation of radiographic parameters and clinical symptoms in adult scoliosis. Spine (Phila Pa 1976). 2005 Mar 15;30(6):682-8. doi: 10.1097/01.brs.0000155425.04536.f7.

  PMID: 15770185 BACKGROUND

• Glassman SD, Bridwell K, Dimar JR, Horton W, Berven S, Schwab F. The impact of positive sagittal balance in adult spinal deformity. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2024-9. doi: 10.1097/01.brs.0000179086.30449.96.

  PMID: 16166889 BACKGROUND

• Smith JS, Bess S, Shaffrey CI, Burton DC, Hart RA, Hostin R, Klineberg E; International Spine Study Group. Dynamic changes of the pelvis and spine are key to predicting postoperative sagittal alignment after pedicle subtraction osteotomy: a critical analysis of preoperative planning techniques. Spine (Phila Pa 1976). 2012 May 1;37(10):845-53. doi: 10.1097/BRS.0b013e31823b0892.

  PMID: 22024904 BACKGROUND

• Le Huec JC, Faundez A, Dominguez D, Hoffmeyer P, Aunoble S. Evidence showing the relationship between sagittal balance and clinical outcomes in surgical treatment of degenerative spinal diseases: a literature review. Int Orthop. 2015 Jan;39(1):87-95. doi: 10.1007/s00264-014-2516-6. Epub 2014 Sep 6.

  PMID: 25192690 BACKGROUND

• Barrey C, Roussouly P, Le Huec JC, D'Acunzi G, Perrin G. Compensatory mechanisms contributing to keep the sagittal balance of the spine. Eur Spine J. 2013 Nov;22 Suppl 6(Suppl 6):S834-41. doi: 10.1007/s00586-013-3030-z. Epub 2013 Sep 20.

  PMID: 24052406 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

• Sarwahi V, Boachie-Adjei O, Backus SI, Taira G. Characterization of gait function in patients with postsurgical sagittal (flatback) deformity: a prospective study of 21 patients. Spine (Phila Pa 1976). 2002 Nov 1;27(21):2328-37. doi: 10.1097/00007632-200211010-00005.

  PMID: 12438980 BACKGROUND

• Gottipati P, Fatone S, Koski T, Sugrue PA, Ganju A. Crouch gait in persons with positive sagittal spine alignment resolves with surgery. Gait Posture. 2014;39(1):372-7. doi: 10.1016/j.gaitpost.2013.08.012. Epub 2013 Aug 18.

  PMID: 24011797 BACKGROUND

• Romei M, Galli M, Motta F, Schwartz M, Crivellini M. Use of the normalcy index for the evaluation of gait pathology. Gait Posture. 2004 Feb;19(1):85-90. doi: 10.1016/s0966-6362(03)00017-1.

  PMID: 14741307 BACKGROUND

• Syczewska M, Dembowska-Baginska B, Perek-Polnik M, Kalinowska M, Perek D. Gait pathology assessed with Gillette Gait Index in patients after CNS tumour treatment. Gait Posture. 2010 Jul;32(3):358-62. doi: 10.1016/j.gaitpost.2010.06.006. Epub 2010 Jul 13.

  PMID: 20630761 BACKGROUND

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Dr Kenny Kwan, BMBCh(Oxon)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 9, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)