A Study of Effects of Age and Hyperkyphosis on Spine Motion and Loading

NCT03008902 | Completed

• 1 other identifier: 2015P000394
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

We are studying how spine movement changes with age, and when people have vertebral fractures (cracks in the bones of the spine) or hyperkyphosis (a forward stooped posture).

Conditions

Kyphosis; Vertebral Fracture

Outcome Measures

Primary Outcomes (1)

• Thoracic spine range of motion, in degrees.

  Full body movement will be recorded during subject movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Passive reflective marker clusters will be attached to subjects along the spine at T1, T4, T5, T8, T9, T12, L1, and additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Marker positions during subject movements will be recorded with sub-millimeter accuracy using an eight-camera system from Vicon Motion Systems (Centennial, CO). Recorded marker positions will be applied to a musculoskeletal model of the subject through an inverse kinematics algorithm in order to provide estimates of thoracic spine angular range of motion in flexion-extension, lateral bending, and axial rotation during each subject movement.

  Day 1

Study Arms (2)

Non-patients

Non-patients, who have not had vertebral fractures or hyperkyphosis, and have not been seen at BIDMC, will be recruited from the community as described in section B3C and B6 below. The non-patient group will consist of 16 healthy adults ages 18-40.

Procedure: Near-infrared passive motion capture recording

Patients

Patients, who have been seen at BIDMC for vertebral fractures or hyperkyphosis, will be identified by review of medical records as described in B3C and B6 below. The patient group will consist of 32 adults ages 75 and older who have previously been diagnosed with a thoracic vertebral fracture at BIDMC.

Procedure: Near-infrared passive motion capture recording

Interventions

Near-infrared passive motion capture recording PROCEDURE

Full body movement will be recorded during movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Movement will be recorded using an eight-camera system. Retroreflective markers are placed at strategic joint locations to characterize limb movement. Accuracies of the marker positions are sub-millimeter, and allow accurate characterization of limb rotation and translation during movements. Passive reflective marker clusters (3 markers each) will be attached to subjects at 8 locations along the spine. Additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Eight EMG surface electrode pairs will be used to record activation from the left and right erector spinae, latissimus dorsi, trapezius and rectus abdominis muscles during all motions.

Non-patients; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-patients Non-patients, who have not have not been seen at BIDMC for vertebral fractures or hyperkyphosis, will be recruited from the local community. The non-patient group will consist of 16 healthy adults ages 18-40. Patients Patients, who have been seen at BIDMC for vertebral fractures or hyperkyphosis, will be identified by review of medical records. The patient group will consist of 32 adults ages 75 and older who have previously been diagnosed with a thoracic vertebral fracture at BIDMC.

You may not qualify if:

• Males and females, ages 18 - 40 years
• Able to perform activities such as walking, standing, sitting, bending or lifting without assistance
• Willing to sign informed consent form
• Conditions that might alter thoracic biomechanics: Examples of these include scoliosis, a history of traumatic thoracic injury or spinal surgery, neuromuscular conditions such as Parkinson's disease or muscular dystrophy.
• Body mass index \> 30 kg/m2
• Pregnancy
• Latex allergies
• Currently taking muscle relaxers, steroids, or narcotics
• Participation in another research study with radiation exposure
• Previous exposure to radiation as part of a medical procedure in the past six months
• Musculoskeletal injury or condition that is currently affecting normal activity or movement. Examples of this could include sprains, strains, dislocations or fractures that prevent one from walking, standing, sitting, bending or lifting in a normal manner.
• Males and females, ages 75 years and older.
• Patients who received a lateral thoracic spine x-ray and had a diagnosis of a vertebral fracture (ICD9 - 805.2) in the year 2011 or later.
• At least 6 months since diagnosis of vertebral fracture.
• Measurable T4-T12 Cobb angle in lateral thoracic spine x-ray.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• University of Denver: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Kyphosis; Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Dennis Anderson, Ph.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Scientist II

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: January 4, 2017
• Study Start: April 18, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)