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Completed

NCT Number: NCT03304405

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Duchess of Kent Children's Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 1 year

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

Secondary outcomes

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

    Time frame: 1 year

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

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

    Time frame: 1 year

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

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

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2017
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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