Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

NCT05359705 | Completed

• 1 other identifier: 4051
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Back Injuries

Outcome Measures

Primary Outcomes (27)

• 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.

  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.

  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.

  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.

  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.

  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.

  Day 1

• 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.

  Day 1

• 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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

  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

  Day 1

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

  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

  Day 1

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

  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

  Day 1

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

  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

  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

  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

  Day 1

Secondary Outcomes (10)

• Comfort

  Day 1

• Trunk stiffness and damping - front angle

  Day 1

• Trunk stiffness and damping - front angular velocity

  Day 1

• Trunk stiffness and damping - front angular acceleration

  Day 1

• Trunk stiffness and damping - back angle

  Day 1

Other Outcomes (28)

• Left Iliocostalis muscle activity (AUC) - walking

  Day 1

• Left Iliocostalis muscle activity (AUC) - stair ascent

  Day 1

• Right Iliocostalis muscle activity (AUC) - walking

  Day 1

Study Arms (1)

Healthy subjects

EXPERIMENTAL

Healthy subjects who meet the Inclusion/Exclusion.

Device: DJO 456; Device: Aspen 456; Device: DJO 464; Device: Aspen 464

Interventions

DJO 456 DEVICE

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

Healthy subjects

Aspen 456 DEVICE

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

Healthy subjects

DJO 464 DEVICE

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

Healthy subjects

Aspen 464 DEVICE

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

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• More Foundation: lead

Study Sites (1)

MORE Foundation

Phoenix, Arizona, 85023, United States

Location

MeSH Terms

Conditions

Back Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: May 4, 2022
• Study Start: June 23, 2021
• Primary Completion: October 16, 2021
• Study Completion: October 16, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

US (1)