Vertebral FractureNCT05010135
Evaluation of Balance and Gait Weight Distribution in Patients With Vertebral Column Fractures
An observational study of Vertebral Fracture and Balance, run by Tung Wah College at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Vertebral Fracture, Balance, Gait, Unsteady
- What is being tested?
- Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessment
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 25 Jan 2021to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- All subjects are aged 60 or above with a history of vertebral fracture, and able to walk without assistance;
- Not received bilateral hip replacement and spinal surgery;
- No known malignance at time of enrollment;
- Able to attend Tung Wah College for examination and assessment, understand and sign the consent form.
Who cannot join
- Unable to attend the research center for receiving examination and tests;
- Unable to give consent;
- Diseases such as stroke and Parkinson's Disease that adversely affect the balance and gait weight distribution;
- Bed bound or wheel-chair bound patients.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Anthony Kwok
Kowloon, 0000
Anthony WL Kwok, Ph.D, 96336734, anthonykwok@twc.edu.hk
Grace PY Szeto, Ph.D, 34686670, Graceszeto@twc.edu.hk
About this study
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.
Read the detailed description
This study evaluates the balance and weight distribution in walking gait in subjects with vertebral column fracture, comparing with the healthy subjects.
Study Objectives:
- To evaluate the balance and gait weight distribution of the vertebral fracture patients.
- To analyze the association between balance and gait weight distribution with fall risks in patients with stable vertebral fractures.
- To construct a community fall prevention protocol.
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:
- . A questionnaire to collect the following information: i. Subjects' demographics, medical and medication history, and fall history. ii. Numeric Pain Rating Scale; ii. Roland-Morris Disability Questionnaire; iii. Oswestry Disability Index (Chinese version); iv. SF-12;
- A 6-meters Up and Go test;
- Hand Grip Strength to evaluate the muscle strength of the subjects
- Flexibility measurement (how far to lean forward);
- Balance and Centre of Gravity evaluation by the TechnoBody Machine;
- . Zebris Gait System for their gait weight distribution evaluation, and
- Humac Norm for the Quadriceps and Hamstrings muscle strength (both sides).
Statistical Analysis:
- Statistical analyses will be performed using SPSS (version 24).
- Two-sided tests and an α-level of 5% were used as the level of significance.
- Chi-square tests were used for categorical variables.
- Two-sample independent t-tests were used for continuous variables.
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:
- All subjects are aged 60 or above with a history of vertebral fracture, and able to walk without assistance;
- Not received a bilateral hip replacement and spinal surgery;
- No known malignance at time of enrollment;
- Able to attend Tung Wah College for examination and assessment, understand, and sign the consent form.
Exclusion criteria:
- Unable to attend the research center for receiving examination and tests;
- Unable to give consent;
- Diseases such as stroke and Parkinson's Disease that adversely affect the balance and gait weight distribution;
- Bed-bound or wheel-chair bound patients.
- Conditions
- Vertebral Fracture, Balance, Gait, Unsteady
- Being tested
- Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessment
- Keywords
- Vertebral fracture, Balance, Gait
- Medical subject headings
- Spinal Fractures, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessmentDevice
Also called TechnoBody Balance assessment: open eyes, closed eyes, single stand and double legs stand, Humac Norm assessment for the Quadriceps and Hamstring strength, Numeric Pain Rating Scale; Roland-Morris Disability Questionnaire; Oswestry Disability Index, SF-12, 6-meters Up and Go test; Hand Grip Strength, Fexibility measurement
To measure the above parameters and to compare between the healthy subjects and the vertebral fracture subjects
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense 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 Receives: Device: Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance (measure by the TechnoBody machine to show the amplitude of body displacement from the centre)
compare between the 2 groups
Measured: Up to 24 weeks
Gait weight distribution (measure by the Zebris Rehabwalk machine to show the force in Newton)
compare between the 2 groups
Measured: Up to 24 weeks
Secondary outcomes (4)
Muscle strength (measure by the Humac Norm machine to evaluate the Quadriceps and Hamstrings strength in Peak Torque, N)
Compare between the 2 groups
Measured: 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).
Compare between the 2 groups
Measured: Up to 24 weeks
Low Back Pain (measure by the Oswestry Disability Index and Roland Morris Disability Questionnaire)
Compare between the 2 groups
Measured: Up to 24 weeks
Quality of Life evaluation (measure by the SF-12 questionnaire)
Compare between 2 groups
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start25 Jan 2021
- Primary completion30 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anthony Kwok, Tung Wah College
- Investigators
- Anthony WL Kwok, Ph.D, Principal investigator, Tung Wah College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010135
- Sponsor's protocol ID
- TungWC
- Status last verified
- Aug 2021
- First submitted
- 18 Feb 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Balance and Gait Weight Distribution in Patients With Vertebral Column Fractures
- ClinicalTrials.gov ID
- NCT05010135
- Acronym / sponsor ID
- TungWC
- Conditions
- Vertebral Fracture, Balance, Gait, Unsteady
- Keywords
- Vertebral fracture, Balance, Gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 18 Aug 2021 (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.
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.
Detailed description
This study evaluates the balance and weight distribution in walking gait in subjects with vertebral column fracture, comparing with the healthy subjects.
Study Objectives:
- To evaluate the balance and gait weight distribution of the vertebral fracture patients.
- To analyze the association between balance and gait weight distribution with fall risks in patients with stable vertebral fractures.
- To construct a community fall prevention protocol.
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:
- . A questionnaire to collect the following information: i. Subjects' demographics, medical and medication history, and fall history. ii. Numeric Pain Rating Scale; ii. Roland-Morris Disability Questionnaire; iii. Oswestry Disability Index (Chinese version); iv. SF-12;
- A 6-meters Up and Go test;
- Hand Grip Strength to evaluate the muscle strength of the subjects
- Flexibility measurement (how far to lean forward);
- Balance and Centre of Gravity evaluation by the TechnoBody Machine;
- . Zebris Gait System for their gait weight distribution evaluation, and
- Humac Norm for the Quadriceps and Hamstrings muscle strength (both sides).
Statistical Analysis:
- Statistical analyses will be performed using SPSS (version 24).
- Two-sided tests and an α-level of 5% were used as the level of significance.
- Chi-square tests were used for categorical variables.
- Two-sample independent t-tests were used for continuous variables.
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:
- All subjects are aged 60 or above with a history of vertebral fracture, and able to walk without assistance;
- Not received a bilateral hip replacement and spinal surgery;
- No known malignance at time of enrollment;
- Able to attend Tung Wah College for examination and assessment, understand, and sign the consent form.
Exclusion criteria:
- Unable to attend the research center for receiving examination and tests;
- Unable to give consent;
- Diseases such as stroke and Parkinson's Disease that adversely affect the balance and gait weight distribution;
- Bed-bound or wheel-chair bound patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subject | – | Device: Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessmentAged 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 | – | Device: Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessmentAged 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- All subjects are aged 60 or above with a history of vertebral fracture, and able to walk without assistance;
- Not received bilateral hip replacement and spinal surgery;
- No known malignance at time of enrollment;
- Able to attend Tung Wah College for examination and assessment, understand and sign the consent form.
Key exclusion criteria (4 listed)
- Unable to attend the research center for receiving examination and tests;
- Unable to give consent;
- Diseases such as stroke and Parkinson's Disease that adversely affect the balance and gait weight distribution;
- Bed bound or wheel-chair bound patients.
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 |
|---|---|---|
| Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessmentAlso: TechnoBody Balance assessment: open eyes, closed eyes, single stand and double legs stand, Humac Norm assessment for the Quadriceps and Hamstring strength, Numeric Pain Rating Scale; Roland-Morris Disability Questionnaire; Oswestry Disability Index, SF-12, 6-meters Up and Go test; Hand Grip Strength, Fexibility measurementTo measure the above parameters and to compare between the healthy subjects and the vertebral fracture subjects | Device | Healthy Subject, Vertebral fracture subjects |
Primary outcome
Balance (measure by the TechnoBody machine to show the amplitude of body displacement from the centre)
Time frame: Up to 24 weeks
compare between the 2 groups
Gait weight distribution (measure by the Zebris Rehabwalk machine to show the force in Newton)
Time frame: Up to 24 weeks
compare between the 2 groups
4 secondary outcomes
Muscle strength (measure by the Humac Norm machine to evaluate the Quadriceps and Hamstrings strength in Peak Torque, N)
Time frame: 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).
Time frame: Up to 24 weeks
Low Back Pain (measure by the Oswestry Disability Index and Roland Morris Disability Questionnaire)
Time frame: Up to 24 weeks
Quality of Life evaluation (measure by the SF-12 questionnaire)
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Anthony WL Kwok, Ph.D principal investigator
Tung Wah College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Fracture and Balance, run by Tung Wah College at 1 site in Hong Kong.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony WL Kwok, Ph.D (+85296336734, anthonykwok@twc.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (measure by the TechnoBody machine to show the amplitude of body displacement from the centre) (time frame: Up to 24 weeks). The study lists 2 primary outcomes in all. 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 18 Aug 2021.