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CompletedNCT03304405Updated May 6, 2020

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

An observational study in Adult Spinal Deformity, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Per ClinicalTrials.gov, last updated 2020-05-06.

Sponsored by The University of Hong Kong · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Sex
All
01

Study 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.

Read the detailed description

With an ageing population, ASD presents as a significant health issue with increasing incidence. Most of the earlier literature concentrated on radiographic measurements of the deformity in the coronal plane, and its surgical correction. However, recent publications have demonstrated that sagittal spinopelvic alignment plays a critical role in pain and disability in patients with ASD, and is a primary determinant of health related quality of life measures. There is substantial evidence that restoration of these parameters after spinal reconstructive surgery is correlated with good clinical outcome.

Maintenance of the ideal sagittal alignment allows an individual to maintain an erect posture with minimal energy expenditure. When there is progressive loss of lumbar lordosis, compensatory mechanisms involving the pelvis, hips and knees occur to extend adjacent segments of the kyphotic spine to allow for compensation of anterior translation of the axis of gravity. However, this compensatory mechanism may potentially result in adverse effect. One of the main disabilities in ASD patients with sagittal imbalance is their decreased walking tolerance. The change in the spinal alignment along with these compensatory mechanisms may result in an inefficient gait worsening their walking tolerance.

Few studies in the literature have investigated the changes in gait pattern in patients with sagittal imbalance. Of those, the patient group was heterogeneous, and the only criterion of sagittal imbalance was a positive sagittal vertical axis (SVA), which the investigators now know is not a complete assessment of the sagittal alignment. The investigators propose to study the change in gait pattern in individuals with abnormal spinopelvic parameters, and how this may affect their quality of lives.

02

Conditions studied

  • Adult Spinal Deformity

Keywords

  • ASD
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testGait 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.

05

What researchers measure

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

    Time frame: 1 year

Secondary outcomes

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

    To investigate the difference in gait kinematics between normal and abnormal sagittal balance using reflective surface markers

    Time frame: 1 year

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

    To investigate the efficiency in gait differences between normal and abnormal sagittal balance using reflective surface markers

    Time frame: 1 year

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

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

    Time frame: 1 year

06

Study locations

1 site
  • Duchess of Kent Children's Hospital
    Hong Kong, Hong Kong
07

References and documents

Publications

  • 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. PubMed 20386505 ↗
  • 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. PubMed 15770185 ↗
  • 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. PubMed 16166889 ↗
  • 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. PubMed 22024904 ↗
  • 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. PubMed 25192690 ↗
  • 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. PubMed 24052406 ↗
  • 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. PubMed 11547203 ↗
  • 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. PubMed 12438980 ↗
  • 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. PubMed 24011797 ↗
  • 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. PubMed 14741307 ↗
  • 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. PubMed 20630761 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03304405
Lead sponsor
The University of Hong Kong
Responsible party
Dr. Kenny Kwan (Clinical Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Oct 9, 2017
Start date
Jun 1, 2016
Primary completion
Jun 1, 2017
Completion
Jun 1, 2017
Last update
May 6, 2020

Study contacts

Dr Kenny Kwan, BMBCh(Oxon)
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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