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

May 5, 2020 updated by: Dr. Kenny Kwan, The University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Duchess of Kent Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 16-294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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