Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity
- Conditions
- Spinal Deformity
- Interventions
- Diagnostic Test: Balance Assessment ScaleDiagnostic Test: Trunk strength measurement with EMGDiagnostic Test: MRI spine/pelvisDiagnostic Test: EOS stereoradiographic full body examDiagnostic Test: Balance Assessment Scale 2Diagnostic Test: Trunk strength measurement with EMG 2
- Registration Number
- NCT04642456
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
Develop reliable methods for functional assessment, for both balance and trunk strength, of Adult Spinal Deformity (ASD) patients and create a first clinical and normative database
1. Compare functionality of ASD and control subjects
2. Relate functionality of ASD patients to their pathology, in terms of spinal deformity and muscle condition
- Detailed Description
The overall aim of the project is to initiate the shift from 2D to 3D mechanically correct and dynamically informed decision-making in Adolescent Idiopathic Scoliosis (AIS), by identifying and integrating the key parameters that overcome the present limitations of 2D static AIS care. Within the timeframe of the project, we will not be able to identify and integrate the key parameters that will overcome all undesired surgical outcomes and therefore, in addition to the overall surgical outcome assessed by patient reported outcome measures (PROMs) we will specifically focus on post-surgery shoulder balance. Since an elevated shoulder after surgery is one of the most common undesired surgical outcomes (approximately 16% of the treated AIS patients) linked with treatment satisfaction and psychological well-being.
To achieve the overall aim, the project comprises two objectives that will allow us to advance towards 3D dynamically informed decision-making in AIS care:
1. To shift towards a 3D mechanically correct overview of the spinal deformity. The current state-of-the-art guidelines for the selection of fusion levels in AIS patients are based on 2D static radiographic parameters\[26\]. In order to improve the current state-of-the-art evaluation method, efforts should be made towards a 3D dynamic visualization of the deformity, especially considering that AIS is a 3D deformity of the spine. In addition, the treating surgeon has only limited information on the mechanical behavior of the spine of the AIS patient as the traction radiograph tests that show the displacement of the spine are typically only assessed qualitatively. To overcome this issue, the spine stiffness should be incorporated in order to thrive towards a biomechanically-informed state-of-the-art 3D model.
2. To identify the key 3D parameters that should be considered by the surgeon Once a biomechanically-informed subject specific 3D model that incorporates the mechanical behavior of the spine is developed within objective 1, the crucial next step will be to identify the key parameters that have the potential to improve the clinical decision-making in AIS. As highlighted before, we will focus on post-surgery shoulder balance and the PROMs.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Trunk strength measurement with EMG Healthy subjects or volunteers Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis EOS stereoradiographic full body exam ASD group MRI spine/pelvis Patient group with ASD Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis 2 EOS stereoradiographic full body exam Balance Assesment Scale 2 Trunk strength measurement with EMG 2 Control group Balance Assessment Scale Healthy subjects or volunteers Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis EOS stereoradiographic full body exam ASD group Balance Assessment Scale Patient group with ASD Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis 2 EOS stereoradiographic full body exam Balance Assesment Scale 2 Trunk strength measurement with EMG 2 Control group MRI spine/pelvis Healthy subjects or volunteers Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis EOS stereoradiographic full body exam Control group EOS stereoradiographic full body exam Healthy subjects or volunteers Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis EOS stereoradiographic full body exam ASD group Trunk strength measurement with EMG Patient group with ASD Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis 2 EOS stereoradiographic full body exam Balance Assesment Scale 2 Trunk strength measurement with EMG 2 ASD group Balance Assessment Scale 2 Patient group with ASD Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis 2 EOS stereoradiographic full body exam Balance Assesment Scale 2 Trunk strength measurement with EMG 2 ASD group Trunk strength measurement with EMG 2 Patient group with ASD Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis 2 EOS stereoradiographic full body exam Balance Assesment Scale 2 Trunk strength measurement with EMG 2 ASD group EOS stereoradiographic full body exam Patient group with ASD Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis 2 EOS stereoradiographic full body exam Balance Assesment Scale 2 Trunk strength measurement with EMG 2
- Primary Outcome Measures
Name Time Method Trunk muscle strength Day 2 Trunk muscle strength is measured with a hand-held dynamometer and repeated within two weeks after the first measurement to assess test-retest reliability.Data of ASD patients and controls will also serve as a first normative and clinical database.
Balance performance on the newly developed ASD specific balance scale Day 2 Balance performance is measured by two raters to assess interrater reliability of the new scale. Patients will also return within two weeks after the first measurement and repeat the balance assessment to assess the test-retest reliability. Data on both ASD patients and Controls will also serve as a first normative and clinical database.
- Secondary Outcome Measures
Name Time Method Echointensity of trunk muscles on MRI Day 1 Fatty infiltration of trunk muscles is measured by the difference in echointensity on MRI images. This will be related to balance performance and trunk muscle strength.
Static 2D radiographic evaluation of spinopelvic parameters Day 1 Spinopelvic parameters are obtained on biplanar radiographic images. These will be related to balance performance and trunk muscle strength.
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium