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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Anthony WL Kwok, Ph.D contact

+85296336734

anthonykwok@twc.edu.hk

Grace PY Szeto, Ph.D contact

+8523468 6721

graceszeto@twc.edu.hk

Hong Kong1 site, 1 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

    Recruiting

Other trials in Hong Kong

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:

  1. To evaluate the balance and gait weight distribution of the vertebral fracture patients.
  2. To analyze the association between balance and gait weight distribution with fall risks in patients with stable vertebral fractures.
  3. 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:

  1. . 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;
  2. A 6-meters Up and Go test;
  3. Hand Grip Strength to evaluate the muscle strength of the subjects
  4. Flexibility measurement (how far to lean forward);
  5. Balance and Centre of Gravity evaluation by the TechnoBody Machine;
  6. . Zebris Gait System for their gait weight distribution evaluation, and
  7. Humac Norm for the Quadriceps and Hamstrings muscle strength (both sides).

Statistical Analysis:

  1. Statistical analyses will be performed using SPSS (version 24).
  2. Two-sided tests and an α-level of 5% were used as the level of significance.
  3. Chi-square tests were used for categorical variables.
  4. 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:

  1. All subjects are aged 60 or above with a history of vertebral fracture, and able to walk without assistance;
  2. Not received a bilateral hip replacement and spinal surgery;
  3. No known malignance at time of enrollment;
  4. Able to attend Tung Wah College for examination and assessment, understand, and sign the consent form.

Exclusion criteria:

  1. Unable to attend the research center for receiving examination and tests;
  2. Unable to give consent;
  3. Diseases such as stroke and Parkinson's Disease that adversely affect the balance and gait weight distribution;
  4. Bed-bound or wheel-chair bound patients.
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 groups in NCT05010135
Study groupRoleWhat they receive
Healthy SubjectAged 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 subjectsAged 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. Low Back Pain (measure by the Oswestry Disability Index and Roland Morris Disability Questionnaire)

    Compare between the 2 groups

    Measured: Up to 24 weeks

  4. 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.

  1. First posted18 Aug 2021
  2. Study start25 Jan 2021
  3. Primary completion30 Aug 2021 (estimated)
  4. Study completion31 Aug 2021 (estimated)

Resources

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)
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

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.

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