Spinal Deformity Clinical Trial
— F-ASDOfficial title:
Development and Reliability of a Balance Assessment Scale and Trunk Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity
Verified date | September 2023 |
Source | Universitaire Ziekenhuizen KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 1 | |
Primary | 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. | Day 2 | |
Primary | 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. | Day 1 | |
Primary | 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. | Day 2 | |
Secondary | 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. | Day 1 | |
Secondary | 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. | Day 1 |
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