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

Primary Purpose

Spinal Deformity

Status

Active

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Balance Assessment Scale

Trunk strength measurement with EMG

MRI spine/pelvis

EOS stereoradiographic full body exam

Balance Assessment Scale 2

Trunk strength measurement with EMG 2

About this trial

This is an interventional diagnostic trial for Spinal Deformity

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria pathological subjects:

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.

Inclusion criteria control group:

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.

Exclusion criteria ASD patients:

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.
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:

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)

Sites / Locations

UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Control group

ASD group

Arm Description

Healthy subjects or volunteers Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis 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

Outcomes

Primary Outcome Measures

Balance performance on the newly developed ASD specific balance scale

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.

Balance performance on the newly developed ASD specific balance scale

Trunk muscle strength

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.

Trunk muscle strength

Secondary Outcome Measures

Echointensity of trunk muscles on MRI

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

Spinopelvic parameters are obtained on biplanar radiographic images. These will be related to balance performance and trunk muscle strength.

Full Information

NCT ID

NCT04642456

First Posted

November 16, 2020

Last Updated

September 15, 2023

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT04642456

Brief Title

Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity

Acronym

F-ASD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Deformity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

control group with healthy subjects and patient group with spinal deformity (ASD)

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Other

Arm Description

Healthy subjects or volunteers Intervention: Balance Assesment Scale Trunk strength measurement with EMG MRI spine/pelvis EOS stereoradiographic full body exam

Arm Title

ASD group

Arm Type

Other

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Balance Assessment Scale

Intervention Description

The newly developed balance, based on the Balance Evaluation Systems Test (BESTest) and Trunk Control Measurement Scale (TCMS), will be administered by two raters (normative and clinical database + interrater reliability)

Intervention Type

Diagnostic Test

Intervention Name(s)

Trunk strength measurement with EMG

Intervention Description

A trunk strength protocol in sitting position, using a hand-held dynamometer is developed. During the trunk strength measurements muscle activity of certain muscles of the trunk will be measured using surface electromyography (EMG)

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI spine/pelvis

Intervention Description

We will be capturing 3D Magnetic Resonance (MR) images of the subject lying supine with extended knees, using a T1 weighted spine-echo (SE) sequence with interslice distance 3 mm in the area of the hip) extended with full spine MRI images (sagittal full spine T1- and T2- weighted images as part of the standard sagittal view of full spine to check for significant stenosis or spinal cord pathology) and additional T1-weighted axial slices at level L4, T12 and T8 with interslice distance 4 mm.The field of view covers the full spine, pelvis and hip smaller trochanter.

Intervention Type

Diagnostic Test

Intervention Name(s)

EOS stereoradiographic full body exam

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Balance Assessment Scale 2

Intervention Description

Repeating the newly developed balance test (test-retest reliability) within 2 weeks after first measurement

Intervention Type

Diagnostic Test

Intervention Name(s)

Trunk strength measurement with EMG 2

Intervention Description

Repeating the trunk strength protocol with EMG within 2 weeks after the first measurement (test-retest reliability)

Primary Outcome Measure Information:

Title

Balance performance on the newly developed ASD specific balance scale

Description

Time Frame

Day 1

Title

Balance performance on the newly developed ASD specific balance scale

Description

Time Frame

Day 2

Title

Trunk muscle strength

Description

Time Frame

Day 1

Title

Trunk muscle strength

Description

Time Frame

Day 2

Secondary Outcome Measure Information:

Title

Echointensity of trunk muscles on MRI

Description

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.

Time Frame

Day 1

Title

Static 2D radiographic evaluation of spinopelvic parameters

Description

Spinopelvic parameters are obtained on biplanar radiographic images. These will be related to balance performance and trunk muscle strength.

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria pathological subjects: 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. Inclusion criteria control group: 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. Exclusion criteria ASD patients: 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. 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: 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)

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

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Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity

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