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Vertebral column fracture presents a significant warning of subsequent osteoporotic fracture and frequent falls. The presence of an osteoporotic vertebral fracture is also a predictor of further risk of vertebral and other osteoporotic fractures. This study provides balance assessment and gait evaluation for subjects with a known vertebral fracture.
Subjects are the known cases of vertebral fracture living in the community. They will be assessed for their balance and gait weight distribution by the TechnoBody for their balance ability, and the Zebris Gait System for the gait weight distribution. The Humac Norm for the lower limb muscle strength.
This study evaluates the balance and weight distribution in walking gait in subjects with vertebral column fracture, comparing with the healthy subjects.
Study Objectives:
Methodology:
Subjects:80 ambulatory subjects with a history of vertebral fracture, aged 60 and above, will be recruited from the community.
Study Design: an observational study by convenient sampling design.
Sample size calculation:
The calculated sample size of vertebral column fractures is 64. Allowing a 20% dropout rate, the round-up figure is 80.
Assessments will include the following:
Statistical Analysis:
The balance, gait weight distribution pattern, and muscle strength will be analyzed by ANOVA.
Correlation analysis will be conducted for the factors of gender, age, and comorbid conditions.
From the results, strategies for fall prevention will be modelled and formulated.
Inclusion Criteria:
Exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subject | Aged 60 and over. Male or Female. Able to give consent, and attend the assessment centre for the balance and gait weight distribution assessment. |
| |
| Vertebral fracture subjects | Aged 60 or over. Male or Female. Able to give consent, and attend the assessment centre for the balance and gait weight distribution assessment. Have been diagnosed by doctors to have the vertebral fracture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessment | Device | To measure the above parameters and to compare between the healthy subjects and the vertebral fracture subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Balance (measure by the TechnoBody machine to show the amplitude of body displacement from the centre) | compare between the 2 groups | Up to 24 weeks |
| Gait weight distribution (measure by the Zebris Rehabwalk machine to show the force in Newton) | compare between the 2 groups | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength (measure by the Humac Norm machine to evaluate the Quadriceps and Hamstrings strength in Peak Torque, N) | Compare between the 2 groups | Up to 24 weeks |
| Positional senses (measure by the position sensor attached on the feet, legs, thighs, lumber spine, thoracic spine and the cervical spine to show the body displacement in angle degrees). |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects are aged 60 or above with a history of vertebral fracture, and able to walk without assistance for vertebral fracture subjects.
All subjects are aged 60 or above with no history of vertebral fracture, and able to walk without assistance for the healthy subjects.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony WL Kwok, Ph.D | Contact | +85296336734 | anthonykwok@twc.edu.hk | |
| Grace PY Szeto, Ph.D | Contact | +8523468 6721 | graceszeto@twc.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Anthony WL Kwok, Ph.D | Tung Wah College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anthony Kwok | Recruiting | Kowloon | 0000 | Hong Kong |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 1, 2021 |
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|
Compare between the 2 groups |
| Up to 24 weeks |
| Low Back Pain (measure by the Oswestry Disability Index and Roland Morris Disability Questionnaire) | Compare between the 2 groups | Up to 24 weeks |
| Quality of Life evaluation (measure by the SF-12 questionnaire) | Compare between 2 groups | Up to 24 weeks |
| Aug 10, 2021 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018737 | Hand Strength |
| ID | Term |
|---|---|
| D053580 | Muscle Strength |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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