Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

More Foundation14 enrolled

Overview

The study will measure and compare range of motion (ROM), motion during simulated activities of daily living ADL), tissue interface pressure (TIP), muscle activation (EMG), and trunk stiffness and damping measurements (TSD) for two pairs of back braces: Postural TLSO (456), and TLSO (464).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Back Injuries

Interventions

DJO 456DEVICE

Data will be recorded while subjects wear a 456 back brace manufactured by DJO Global

Aspen 456DEVICE

Data will be recorded while subjects wear a 456 back brace manufactured by Aspen Medical Products

DJO 464DEVICE

Data will be recorded while subjects wear a 464 back brace manufactured by DJO Global

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI \< 40 * English speaking * Subjects who have read and signed IRB approved informed consent for this study * Of appropriate body size for back brace per instructions for use Exclusion Criteria: * History of back pain or back injury requiring medical care within the previous 12 months * History of spinal surgery, physical or chiropractic therapy of the back * History of spinal spondylosis or osteoporosis * Pregnant * Currently Incarcerated

Locations (1)

MORE Foundation

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Flexion - Sagittal plane

Angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects flex their trunk relative to their pelvis in the sagittal plane.

Time frame: Day 1

Extension - Sagittal plane

Angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects extend their trunk relative to their pelvis in the sagittal plane.

Time frame: Day 1

Range of motion - Frontal plane

Range of motion of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects bend their trunk relative to their pelvis laterally to the right and left in the frontal plane.

Time frame: Day 1

Range of motion - Transverse plane

Range of motion of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rotate their trunk relative to their pelvis laterally to the right and left in the transverse plane.

Time frame: Day 1

Rotation angle while looking over shoulder

Maximum rotation angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rotate their trunk relative to their pelvis to look at an object placed 150 degrees behind them.

Time frame: Day 1

Range of motion in the sagittal plane when rising from a chair

Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rise from a chair.

Time frame: Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Data will be recorded while subjects wear a 464 back brace manufactured by Aspen Medical Products

Range of motion in the sagittal plane when returning to a seated position

Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects move from an upright standing position to a seated position.

Flexion angle in the sagittal plane when touching right hallux in a seated position

Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forward and down to touch their right hallux while in a seated position.

Time frame: Day 1

Flexion angle in the sagittal plane when picking an object up from the floor

Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forward and down to pick up a 85mm diameter object weighing 500grams from the floor from a standing position.

Time frame: Day 1

Range of motion in the sagittal plane while walking on a level surface

Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.

Time frame: Day 1

Range of motion in the frontal plane while walking on a level surface

Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.

Time frame: Day 1

Range of motion in the transverse plane while walking on a level surface

Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.

Time frame: Day 1

Range of motion in the sagittal plane while ascending stairs.

Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps

Time frame: Day 1

Range of motion in the sagittal plane while descending stairs.

Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps

Time frame: Day 1

Range of motion in the frontal plane while ascending stairs.

Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps

Time frame: Day 1

Range of motion in the frontal plane while descending stairs.

Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps

Time frame: Day 1

Range of motion in the transverse plane while ascending stairs.

Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps

Time frame: Day 1

Range of motion in the transverse plane while descending stairs.

Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps

Time frame: Day 1

Flexion angle in the sagittal plane when reaching forwards and around an object with their right hand.

Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand

Time frame: Day 1

Flexion angle in the sagittal plane when reaching forwards and around an object with their left hand.

Time frame: Day 1

Lateral angle in the frontal plane when reaching forwards and around an object with their right hand.

Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand

Time frame: Day 1

Lateral angle in the frontal plane when reaching forwards and around an object with their left hand.

Time frame: Day 1

Rotation angle in the transverse plane when reaching forwards and around an object with their right hand.

Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand

Time frame: Day 1

Rotation angle in the transverse plane when reaching forwards and around an object with their left hand.

Time frame: Day 1

Flexion angle in the sagittal plane when reaching when reach down to pick up a suitcase

Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand

Time frame: Day 1

Lateral angle in the frontal plane when reaching when reach down to pick up a suitcase

Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand

Time frame: Day 1

Rotation angle in the transverse plane when reaching when reach down to pick up a suitcase

Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand

Time frame: Day 1

Secondary Outcomes

Comfort

Subjects will be asked to provide a subjective rating of brace comfort using a 10cm visual analog comfort rating scale for each of the back braces during all ROM and ADL testing conditions. The endpoints of the scale will be labeled "Very comfortable", and "Very uncomfortable" at 0 and 10cm respectively.

Time frame: Day 1

Trunk stiffness and damping - front angle

Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to front of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular motion of the upper body in degrees will be measured.

Time frame: Day 1

Trunk stiffness and damping - front angular velocity

Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to front of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular velocity of the upper body after force release will be measured in degrees/second.

Time frame: Day 1

Trunk stiffness and damping - front angular acceleration

Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to front of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular acceleration of the upper body after force release will be measured in degrees/second/second.

Time frame: Day 1

Trunk stiffness and damping - back angle

Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to back of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular motion of the upper body in degrees will be measured.

Time frame: Day 1

Trunk stiffness and damping - back angular velocity

Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to back of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular velocity of the upper body after force release will be measured in degrees/second.

Time frame: Day 1

Trunk stiffness and damping - back angular acceleration

Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to back of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular acceleration of the upper body after force release will be measured in degrees/second/second.

Time frame: Day 1

Trunk stiffness and damping - right side angle

Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to right side of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular motion of the upper body in degrees will be measured.

Time frame: Day 1

Trunk stiffness and damping - right side angular velocity

Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to right side of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular velocity of the upper body after force release will be measured in degrees/second.

Time frame: Day 1

Trunk stiffness and damping - right side angular acceleration

Each subject will kneel in a apparatus with their pelvis fixed in position and their trunk upright. A load will be attached to right side of their upper body and a force applied. The force will be released and subsequent upper trunk motion measured using an inertial measurement unit. Maximum angular velocity of the upper body after force release will be measured in degrees/second/second.

Time frame: Day 1