Spinal DeformityF-ASDNCT04642456
Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity
A study testing Trunk strength measurement and EOS stereoradiographic full body exam in people with Spinal Deformity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- Trunk strength measurement and EOS stereoradiographic full body exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2021to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (>18 years old) subjects suffering from a adult spinal deformity with sagittal or coronal plane misalignment diagnosed on EOS imaging.
- Ability to walk at least 50 meters distance independently without a walking aid.
- No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.
- Adults (> 18 year old)
- No current history of back pain and spinal deformity.
- Ability to walk at least 1000 meters distance independently without a walking aid.
- No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.
Who cannot join
- Age < 18 years old and > 79 years old
- Absence of adult spinal deformity
- 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 history of spinal fusion surgery.
Show all 14Show fewer
- 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)
- 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
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Compare functionality of ASD and control subjects
- Relate functionality of ASD patients to their pathology, in terms of spinal deformity and muscle condition
Read the 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:
- 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.
- 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.
- Conditions
- Spinal Deformity
- Being tested
- Trunk strength measurement, EOS stereoradiographic full body exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk strength measurementDiagnostic test
A trunk strength protocol in sitting position, using a hand-held dynamometer is developed.
EOS stereoradiographic full body examDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Healthy subjects or volunteers
Intervention:
Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis EOS stereoradiographic full body exam Receives: Diagnostic Test: Trunk strength measurement; Diagnostic Test: EOS stereoradiographic full body exam |
| ASD group | Other | 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 Receives: Diagnostic Test: Trunk strength measurement; Diagnostic Test: EOS stereoradiographic full body exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From screening till week 2
Secondary outcomes (1)
Static 2D radiographic evaluation of spinopelvic parameters
Spinopelvic parameters are obtained on biplanar radiographic images. These will be related to trunk muscle strength.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 May 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- control group with healthy subjects and patient group with spinal deformity (ASD)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lieven Moke, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642456
- Sponsor's protocol ID
- S61860
- Acronym
- F-ASD
- Status last verified
- Mar 2026
- First submitted
- 16 Nov 2020
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Reliability of a Balance Assessment Scale and Trunk Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity
- ClinicalTrials.gov ID
- NCT04642456
- Acronym / sponsor ID
- F-ASD / S61860
- Conditions
- Spinal Deformity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Develop reliable methods for functional assessment, for trunk strength, of Adult Spinal Deformity (ASD) patients and create a first clinical and normative database
- Compare functionality of ASD and control subjects
- 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:
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control group with healthy subjects and patient group with spinal deformity (ASD)
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Diagnostic Test: Trunk strength measurement, Diagnostic Test: EOS stereoradiographic full body examHealthy subjects or volunteers Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis EOS stereoradiographic full body exam |
| ASD group | Other | Diagnostic Test: Trunk strength measurement, Diagnostic Test: EOS stereoradiographic full body examPatient 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (>18 years old) subjects suffering from a adult spinal deformity with sagittal or coronal plane misalignment diagnosed on EOS imaging.
- Ability to walk at least 50 meters distance independently without a walking aid.
- No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.
- Adults (> 18 year old)
- No current history of back pain and spinal deformity.
Key exclusion criteria (14 listed)
- Age < 18 years old and > 79 years old
- Absence of adult spinal deformity
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trunk strength measurementA trunk strength protocol in sitting position, using a hand-held dynamometer is developed. | Diagnostic test | ASD group, Control group |
| EOS stereoradiographic full body examEvery 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 | ASD group, Control group |
Primary outcome
Trunk muscle strength
Time frame: From screening till week 2
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.
1 secondary outcome
Static 2D radiographic evaluation of spinopelvic parameters
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lieven Moke principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trunk strength measurement and EOS stereoradiographic full body exam in people with Spinal Deformity, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lieven Moke (+32 16 34 08 84, lieven.moke@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk muscle strength (time frame: From screening till week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.