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

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.

Study Overview

• Status: Recruiting
• Conditions: Vertebral Fracture; Gait, Unsteady; Balance
• Intervention / Treatment: Device: Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessment

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Anthony WL Kwok, Ph.D; Phone Number: +85296336734; Email: anthonykwok@twc.edu.hk
• Study Contact Backup: Name: Grace PY Szeto, Ph.D; Phone Number: +8523468 6721; Email: graceszeto@twc.edu.hk

Study Locations

• Hong Kong
  • Kowloon, Hong Kong, 0000
    • Recruiting
    • Anthony Kwok
    • Contact: Anthony WL Kwok, Ph.D; Phone Number: 96336734; Email: anthonykwok@twc.edu.hk
    • Contact: Grace PY Szeto, Ph.D; Phone Number: 34686670; Email: Graceszeto@twc.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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; Other 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
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	Device: 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; Other 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Tung Wah College
• Investigators: Principal Investigator: Anthony WL Kwok, Ph.D, Tung Wah College

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2021
• Primary Completion (ANTICIPATED): August 30, 2021
• Study Completion (ANTICIPATED): August 31, 2021

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (ACTUAL): August 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Balance; Gait; Vertebral fracture
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Gait Disorders, Neurologic; Spinal Fractures
• Other Study ID Numbers: TungWC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No