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

NCT05010135 | Unknown

• 1 other identifier: TungWC
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Fracture; Balance; Gait, Unsteady

Keywords

Vertebral fracture; Balance; Gait

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Muscle strength (measure by the Humac Norm machine to evaluate the Quadriceps and Hamstrings strength in Peak Torque, N)

  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).

  Up to 24 weeks

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

  Up to 24 weeks

• Quality of Life evaluation (measure by the SF-12 questionnaire)

  Up to 24 weeks

Study Arms (2)

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

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

Interventions

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

Also known as: 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

Healthy Subject; Vertebral fracture subjects

Eligibility Criteria

• Age: 60 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tung Wah College: lead

Study Sites (1)

Anthony Kwok

Kowloon, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Spinal Fractures; Gait Disorders, Neurologic

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anthony WL Kwok, Ph.D

  Tung Wah College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony WL Kwok, Ph.D

CONTACT

+85296336734; anthonykwok@twc.edu.hk

Grace PY Szeto, Ph.D

CONTACT

+8523468 6721; graceszeto@twc.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: August 18, 2021
• Study Start: January 25, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 31, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

HK (1)