Evaluation of Balance and Gait Weight Distribution in Patients With Vertebral Column Fractures

NCT ID: NCT05010135

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2021-08-31

Brief 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. 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:

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.

Conditions

Vertebral Fracture; Balance; Gait, Unsteady

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessment

Intervention Type: DEVICE

To measure the above parameters and to compare between the healthy subjects and the vertebral fracture subjects

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

Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessment

Intervention Type: DEVICE

To measure the above parameters and to compare between the healthy subjects and the vertebral fracture subjects

Interventions

Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessment

To measure the above parameters and to compare between the healthy subjects and the vertebral fracture subjects

Intervention Type: DEVICE

Other Intervention Names

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

Eligibility Criteria

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 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tung Wah College

OTHER

Sponsor Role: lead

Responsible Party

Dr. Anthony Kwok

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony WL Kwok, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tung Wah College

Locations

Anthony Kwok

Kowloon, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Anthony WL Kwok, Ph.D

Role: CONTACT

anthonykwok@twc.edu.hk

+85296336734

Grace PY Szeto, Ph.D

Role: CONTACT

graceszeto@twc.edu.hk

+8523468 6721

Facility Contacts

Anthony WL Kwok, Ph.D

Role: primary

anthonykwok@twc.edu.hk

96336734

Grace PY Szeto, Ph.D

Role: backup

Graceszeto@twc.edu.hk

34686670

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

TungWC

Identifier Type: -

Identifier Source: org_study_id