Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment (ASD)
Primary Purpose
Spinal Deformity
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
2D versus 3D analysis of EOS stereo radiographic analysis
Static versus dynamic analysis
Pre- versus postoperative analysis
Reliability of the dynamic evaluation
Sponsored by
About this trial
This is an interventional other trial for Spinal Deformity focused on measuring Sagittal plane misalignment, Trunk and lower limb, Motion analysis, EOS stereo radiography
Eligibility Criteria
Inclusion Criteria:
Pathological group
- Adults suffering from a spinal deformity with or without sagittal misalignment presenting at the outdoors spinal clinic in the University Hospitals Leuven campus Pellenberg, Belgium
- Age > 18 years old and < 79 years old
- Scoring at least 25 out of 30 on Mini Mental State Examination
- Ability to walk at least 50 meters distance independently without a walking aid
- All subjects participating in study number 2 and 3 should also be able to walk 10 minutes on a instrumented treadmill to obtain a complete movement analysis with dynamic EMG
- Ability and willingness of patient to attend follow-up visits and complete patient questionnaires
- Completed patient informed consent
Control group
- Asymptomatic adults not suffering from a spinal deformity leading to a pathological sagittal alignment presenting as volunteer in the University Hospitals Leuven, Belgium
- Age >18 years old and < 79 years old
- Scoring at least 27 out of 30 on Mini Mental State Examination
- Ability to walk at least 1000 meters distance independently without a walking aid
- Ability and willingness of patient to attend follow-up visits and complete patient questionnaires
- Completed patient informed consent
Exclusion Criteria:
Pathological group
- Age < 18 years old and > 79 years old
- Absence of adult spinal deformity
- Scoring less than 25 out of 30 on Mini Mental State Examination
- Non-ability to walk at least 50 meters distance independently, with or without a walking aid.
- Missing patient informed consent
- Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and/or Vestibular lesion
- Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (> 3 cm)
Control group
- Age < 18 years old and > 79 years old
- Backpain and/or Sciatica at time of the study
- Presence of adult spinal deformity leading to a pathological sagittal alignment
- Scoring less than 27 out of 30 on Mini Mental State Examination
- Non-ability to walk at least 1000 meters distance independently without a walking aid
- Missing patient informed consent
- Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and/or Vestibular lesion
- Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (> 3 cm)
- BMI > 27
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
ASD with decompensated sagittal misalignment
ASD with compensated sagittal misalignment
ASD without sagittal misalignment
Control group
Arm Description
Adults suffering from a spinal deformity with a decompensated sagittal misalignment
Adults suffering from a spinal deformity with a compensated sagittal misalignment
Adults suffering from a spinal deformity without a sagittal misalignment
Asymptomatic adults not suffering from a spinal deformity
Outcomes
Primary Outcome Measures
Health-Related Quality of Life (HRQL) score
To evaluate the domains related to physical, mental, emotional, and social functioning
Postoperative state of the art radiographic evaluation (EOS/CT)
To investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual
Postoperative state of the art radiographic evaluation (EOS/CT) in correlation with HRQL
To investigate the correlation of radiographic evaluation with HRQL
3D motion analysis and balance tests
3D motion analysis and balance tests are combined to investigate the correlation with the static EOS stereo radiographic evaluation/CT/MRI
3D motion analysis and balance tests to investigate the dynamic function
3D motion analysis and balance tests are combined to investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual
3D motion analysis and balance tests in correlation with HRQL
3D motion analysis and balance tests are combined to investigate the correlation with HRQL (Health-Related Quality of Life)
Static EOS stereo radiographic evaluation
To investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual
Secondary Outcome Measures
Falls Efficacy Scale-International (FES-I)
To measure the concerns about falling
EuroQol-5D-3L
To evaluate mobility, self-care, daily activities, pain / discomfort and anxiety / depression
Mini-Mental State Examination (MMSE)
To evaluate cognitive functions: attention and orientation, memory, registration, recollection, calculation, language and praxis.
Karnofsky Performance Score (KPS)
To determine the ability of patient to tolerate therapies in illness. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death.
Cumulative Illness Rating Scale
To determine the presence of comorbidities. The scale format provides for 13 relatively independent areas grouped under body systems. Ratings are made on a 5-point "degree of severity" scale, ranging from "none" to "extremely severe".
Full Information
NCT ID
NCT04812730
First Posted
March 18, 2021
Last Updated
September 22, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04812730
Brief Title
Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment
Acronym
ASD
Official Title
Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A good understanding of the principles of balance is vital to achieve optimal outcomes when treating spinal disorders. A complex interaction of the neuromotor system and muscular recruitment is necessary for ergonomic balance and deliberate displacement of the human body. Sagittal plane misalignment in spinal deformities challenges balance mechanisms used for maintenance of an upright posture. The occurrence of postoperative complications after spinal deformity correction like under-correction of sagittal misalignment, postoperative reciprocal changes in thoracic kyphosis, proximal junctional kyphosis and failure of instrumentation are possibly due to the current state-of-the art inadequate diagnostic work-up.
Investigators do not fully understand the roll of vision and exact strategy of recruitment of neuromuscular units (trunk, pelvis, lower limbs) in patients with sagittal plane misalignment during standing and walking. To understand this, a dynamic evaluation of individuals with spinal deformities is needed. Currently there is only very little research performed in the field of clinical balance tests and instrumented movement analysis in patients with spinal deformity.
The challenge for future studies is to further unravel the relation between trunk and lower limb movements, grouped into functional movement patterns. Moreover, additional information on trunk and lower limb kinetics and muscle activity (using dynamic electromyography (EMG)) will highly contribute to the understanding of this functional relationship, and will provide more in-depth insights into compensatory mechanisms of the trunk versus the lower limbs and vice versa.
Detailed Description
A good understanding of the principles of balance is vital to achieve optimal outcomes when treating spinal disorders. A complex interaction of the neuromotor system and muscular recruitment is necessary for ergonomic balance and deliberate displacement of the human body. Spinal alignment has to allow an individual to stand pain free with minimal muscular energy expenditure. This concept is reflected in the "Cone of Economy" principle by Jean Dubousset. Sagittal plane misalignment in spinal deformities challenges balance mechanisms used for maintenance of an upright posture. The current state of the art diagnostic work-up of spinal deformities is mainly a static 2D radiological evaluation in Scoliosis Research Society (SRS) free standing position with analysis of the spinopelvic parameters as described by Duval-Beaupmet and others.
Until now sagittal balance has been assessed by dropping a vertical plumb line from C7 vertebral body center and quantifying the distance of the sacral plate from this vertical (Sagittal Vertical Axis or SVA). Others measure the T1 spinopelvic inclination angle (T1-SPI). SVA, T1-SPI and pelvic tilt are correlated with self-reported disability and health related quality of life scores (HRQL) compared to age- and sex-related normal subjects.
Literature suggests a multifactorial etiology of impaired balance capacity with neurological or vestibular disease, muscular atrophy in mm erector spinae, increasing age, low back pain and history of spinal surgery. The occurrence of postoperative complications after spinal deformity correction like under-correction of sagittal misalignment, postoperative reciprocal changes in thoracic kyphosis, proximal junctional kyphosis and failure of instrumentation are possibly due to the current state-of-the art inadequate diagnostic work-up.
Investigators do not fully understand the roll of vision and exact strategy of recruitment of neuromuscular units (trunk, pelvis, lower limbs) in patients with sagittal plane misalignment during standing and walking. Several compensatory mechanisms in sagittal balance disorders are identified in the static situation. Intra-spinal mechanisms like hyperextension of lumbar discs, retrolisthesis of lumbar vertebrae, reduction of thoracic kyphosis, and pelvic back tilt and extra-spinal mechanisms like knee flessum and ankle extension are suggested to act as compensatory mechanisms. In literature, a strong correlation between the occurrence of knee flessum and lack of lumbar lordosis is seen. To understand these mechanisms a dynamic evaluation of individuals with spinal deformities is needed. Currently there is only very little research performed in the field of clinical balance tests and instrumented movement analysis in patients with spinal deformity. With regard to clinical balance tests the Fullerton Advanced Balance Scale (FAB scale) is presented as a reliable tool to predict wether or not higher-functioning older adults will fall. The FAB scale is a reliable and valid tool in Parkinson disease with minimal ceiling effect and shows promising results in detecting small balance disturbances.The use of these balance tests in patients suffering from spinal deformity with sagittal imbalance has not been validated in literature till now. Last but not least the use of instrumented movement analysis to examen gait in subjects with spinal deformity is unconventional. Subjects with fixed sagittal balance are reported to have a significant slower walking speed and poorer endurance score relative to age matched controls. An inadequate use of pelvic tilt during walking is also observed. Subjects with forward inclination of the trunk present with abnormal kinematics and kinetics of the lower limbs during walking compared to age- and sex-related normal subjects. When deformity exceeds the primary compensation mechanisms, additional mechanisms, such as crouch gait, are used to reorient the trunk to a more vertical position.
The currently used trunk model in movement analysis in UZ Leuven has been developed by Heyrman et al after the work of Leardini et al. Armand et al also considered the thorax not as one rigid segment and presented the use of an optimal marker placement set on the thorax for clinical gait analysis. However they did not include markers on the head. Heyrman et al showed in their study with cerebral palsy children (CP) that increased altered trunk movements during gait were related to a lower performance on the Trunk Control Measurement Scale (TCMS) in sitting, indicating the presence of an underlying trunk control deficit. These authors were thus able to show a correlation between a clinical postural test like the TCMS and trunk-and lower limb parameters during gait. However, they could not find a significant correlation between overall altered trunk movements and altered lower limb movements during gait in a CP population and concluded that observed thorax movements during gait, most likely are the resultant of both compensatory movements for lower limb deficits and an underlying trunk control deficit. The current concept of thinking is that in an adult spinal deformity population with sagittal plane misalignment the observed altered movements in the lower limbs during standing and gait are compensatory for the forward inclination of the trunk. The challenge for future studies is to further unravel the relation between trunk and lower limb movements, grouped into functional movement patterns. Moreover, additional information on trunk and lower limb kinetics and muscle activity (using dynamic electromyography (EMG)) will highly contribute to the understanding of this functional relationship, and will provide more in-depth insights into compensatory mechanisms of the trunk versus the lower limbs and vice versa.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Deformity
Keywords
Sagittal plane misalignment, Trunk and lower limb, Motion analysis, EOS stereo radiography
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
185 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASD with decompensated sagittal misalignment
Arm Type
Other
Arm Description
Adults suffering from a spinal deformity with a decompensated sagittal misalignment
Arm Title
ASD with compensated sagittal misalignment
Arm Type
Other
Arm Description
Adults suffering from a spinal deformity with a compensated sagittal misalignment
Arm Title
ASD without sagittal misalignment
Arm Type
Other
Arm Description
Adults suffering from a spinal deformity without a sagittal misalignment
Arm Title
Control group
Arm Type
Other
Arm Description
Asymptomatic adults not suffering from a spinal deformity
Intervention Type
Other
Intervention Name(s)
2D versus 3D analysis of EOS stereo radiographic analysis
Intervention Description
The use of EOS stereo radiographic analysis and health related quality of life scores to measure the distance of the center of acoustic meati in the transversal plane with respect to the gravity line
Intervention Type
Other
Intervention Name(s)
Static versus dynamic analysis
Intervention Description
The use of clinical postural tests and instrumented movement analysis to evaluate the importance of muscle fatigue and compensation mechanisms
Intervention Type
Other
Intervention Name(s)
Pre- versus postoperative analysis
Intervention Description
The use of EOS stereo radiographic imaging and motion analysis to understand the compensation mechanisms in trunk, pelvis and lower limbs and the correlation between primary and secondary mechanisms.
Intervention Type
Other
Intervention Name(s)
Reliability of the dynamic evaluation
Intervention Description
Repeated measurements of the different aspects of the dynamic evaluation protocol (strenght measurements of trunk muscles, balance evaluation and movement analysis) will serve to evaluate the test-retest reliability and intra-rater reliability of the different protocols
Primary Outcome Measure Information:
Title
Health-Related Quality of Life (HRQL) score
Description
To evaluate the domains related to physical, mental, emotional, and social functioning
Time Frame
up to 2 years
Title
Postoperative state of the art radiographic evaluation (EOS/CT)
Description
To investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual
Time Frame
up to 2 years
Title
Postoperative state of the art radiographic evaluation (EOS/CT) in correlation with HRQL
Description
To investigate the correlation of radiographic evaluation with HRQL
Time Frame
up to 2 years
Title
3D motion analysis and balance tests
Description
3D motion analysis and balance tests are combined to investigate the correlation with the static EOS stereo radiographic evaluation/CT/MRI
Time Frame
up to 2 years
Title
3D motion analysis and balance tests to investigate the dynamic function
Description
3D motion analysis and balance tests are combined to investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual
Time Frame
up to 2 years
Title
3D motion analysis and balance tests in correlation with HRQL
Description
3D motion analysis and balance tests are combined to investigate the correlation with HRQL (Health-Related Quality of Life)
Time Frame
up to 2 years
Title
Static EOS stereo radiographic evaluation
Description
To investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Falls Efficacy Scale-International (FES-I)
Description
To measure the concerns about falling
Time Frame
up to 2 years
Title
EuroQol-5D-3L
Description
To evaluate mobility, self-care, daily activities, pain / discomfort and anxiety / depression
Time Frame
up to 2 years
Title
Mini-Mental State Examination (MMSE)
Description
To evaluate cognitive functions: attention and orientation, memory, registration, recollection, calculation, language and praxis.
Time Frame
up to 2 years
Title
Karnofsky Performance Score (KPS)
Description
To determine the ability of patient to tolerate therapies in illness. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death.
Time Frame
up to 2 years
Title
Cumulative Illness Rating Scale
Description
To determine the presence of comorbidities. The scale format provides for 13 relatively independent areas grouped under body systems. Ratings are made on a 5-point "degree of severity" scale, ranging from "none" to "extremely severe".
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pathological group
Adults suffering from a spinal deformity with or without sagittal misalignment presenting at the outdoors spinal clinic in the University Hospitals Leuven campus Pellenberg, Belgium
Age > 18 years old and < 79 years old
Scoring at least 25 out of 30 on Mini Mental State Examination
Ability to walk at least 50 meters distance independently without a walking aid
All subjects participating in study number 2 and 3 should also be able to walk 10 minutes on a instrumented treadmill to obtain a complete movement analysis with dynamic EMG
Ability and willingness of patient to attend follow-up visits and complete patient questionnaires
Completed patient informed consent
Control group
Asymptomatic adults not suffering from a spinal deformity leading to a pathological sagittal alignment presenting as volunteer in the University Hospitals Leuven, Belgium
Age >18 years old and < 79 years old
Scoring at least 27 out of 30 on Mini Mental State Examination
Ability to walk at least 1000 meters distance independently without a walking aid
Ability and willingness of patient to attend follow-up visits and complete patient questionnaires
Completed patient informed consent
Exclusion Criteria:
Pathological group
Age < 18 years old and > 79 years old
Absence of adult spinal deformity
Scoring less than 25 out of 30 on Mini Mental State Examination
Non-ability to walk at least 50 meters distance independently, with or without a walking aid.
Missing patient informed consent
Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and/or Vestibular lesion
Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (> 3 cm)
Control group
Age < 18 years old and > 79 years old
Backpain and/or Sciatica at time of the study
Presence of adult spinal deformity leading to a pathological sagittal alignment
Scoring less than 27 out of 30 on Mini Mental State Examination
Non-ability to walk at least 1000 meters distance independently without a walking aid
Missing patient informed consent
Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and/or Vestibular lesion
Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (> 3 cm)
BMI > 27
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieven Moke
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment
We'll reach out to this number within 24 hrs