Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity (F-ASD)

Development and Reliability of a Balance Assessment Scale and Trunk Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity

Develop reliable methods for functional assessment, for 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

Study Overview

• Status: Recruiting
• Conditions: Spinal Deformity
• Intervention / Treatment: Diagnostic test: EOS stereoradiographic full body exam; Diagnostic test: Trunk strength measurement

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lieven Moke; Phone Number: +32 16 34 08 84; Email: lieven.moke@uzleuven.be
• Study Contact Backup: Name: Anna a Tarasiuk; Phone Number: 003216 338818; Email: orthopedie.research@uzleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria pathological subjects:

1. Adult (>18 years old) subjects suffering from a adult spinal deformity with sagittal or coronal plane misalignment diagnosed on EOS imaging.
2. Ability to walk at least 50 meters distance independently without a walking aid.
3. No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.

Inclusion criteria control group:

1. Adults (> 18 year old)
2. No current history of back pain and spinal deformity.
3. Ability to walk at least 1000 meters distance independently without a walking aid.
4. No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.

Exclusion criteria ASD patients:

1. Age < 18 years old and > 79 years old
2. Absence of adult spinal deformity
3. Non-ability to walk at least 50 meters distance independently, with or without a walking aid.
4. Missing patient informed consent
5. Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and/or Vestibular lesion
6. Patients with a history of spinal fusion surgery.
7. 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)

Exclusion criteria control group:

1. Age < 18 years old and > 79 years old
2. Backpain and/or Sciatica at time of the study
3. Presence of adult spinal deformity leading to a pathological sagittal alignment
4. Non-ability to walk at least 1000 meters distance independently without a walking aid
5. Missing patient informed consent
6. Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and/or Vestibular lesion
7. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Healthy subjects or volunteers Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis EOS stereoradiographic full body exam	Diagnostic test: EOS stereoradiographic full body exam; Every subject included in the study will undergo a stereoradiographic full body EOS exam completed with Gravity Line (GL) location, recorded by a force plate on the floor; Diagnostic test: Trunk strength measurement; A trunk strength protocol in sitting position, using a hand-held dynamometer is developed.
Other: ASD group; 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	Diagnostic test: EOS stereoradiographic full body exam; Every subject included in the study will undergo a stereoradiographic full body EOS exam completed with Gravity Line (GL) location, recorded by a force plate on the floor; Diagnostic test: Trunk strength measurement; A trunk strength protocol in sitting position, using a hand-held dynamometer is developed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk muscle strength	Trunk muscle strength is measured according to a trunk strength hand-held dynamometer protocol and repeated within two weeks after the first measurement to assess both interrater and test-retest reliability.	From screening till week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static 2D radiographic evaluation of spinopelvic parameters	Spinopelvic parameters are obtained on biplanar radiographic images. These will be related to trunk muscle strength.	Day 1

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Lieven Moke, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: S61860

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No