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Completed

NCT Number: NCT05359705

Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

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).

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Key information

Conditions

Back Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MORE Foundation

Phoenix, Arizona, 85023, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DJO 456

Device

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

Aspen 456

Device

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

DJO 464

Device

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

Aspen 464

Device

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

Primary outcomes

  1. Flexion - Sagittal plane

    Time frame: Day 1

    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.

  2. Extension - Sagittal plane

    Time frame: Day 1

    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.

  3. Range of motion - Frontal plane

    Time frame: Day 1

    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.

  4. Range of motion - Transverse plane

    Time frame: Day 1

    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.

  5. Rotation angle while looking over shoulder

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

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

    Time frame: Day 1

    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.

  13. Range of motion in the sagittal plane while ascending stairs.

    Time frame: Day 1

    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

  14. Range of motion in the sagittal plane while descending stairs.

    Time frame: Day 1

    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

  15. Range of motion in the frontal plane while ascending stairs.

    Time frame: Day 1

    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

  16. Range of motion in the frontal plane while descending stairs.

    Time frame: Day 1

    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

  17. Range of motion in the transverse plane while ascending stairs.

    Time frame: Day 1

    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

  18. Range of motion in the transverse plane while descending stairs.

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

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

    Time frame: Day 1

    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

Secondary outcomes

  1. Comfort

    Time frame: Day 1

    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.

  2. Trunk stiffness and damping - front angle

    Time frame: Day 1

    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.

  3. Trunk stiffness and damping - front angular velocity

    Time frame: Day 1

    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.

  4. Trunk stiffness and damping - front angular acceleration

    Time frame: Day 1

    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.

  5. Trunk stiffness and damping - back angle

    Time frame: Day 1

    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.

  6. Trunk stiffness and damping - back angular velocity

    Time frame: Day 1

    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.

  7. Trunk stiffness and damping - back angular acceleration

    Time frame: Day 1

    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.

  8. Trunk stiffness and damping - right side angle

    Time frame: Day 1

    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.

  9. Trunk stiffness and damping - right side angular velocity

    Time frame: Day 1

    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.

  10. Trunk stiffness and damping - right side angular acceleration

    Time frame: Day 1

    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.

Other outcomes

  1. Left Iliocostalis muscle activity (AUC) - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left iliocostalis muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  2. Left Iliocostalis muscle activity (AUC) - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left iliocostalis muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  3. Right Iliocostalis muscle activity (AUC) - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right iliocostalis muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  4. Right Iliocostalis muscle activity (AUC) - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right iliocostalis muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  5. Maximum left Iliocostalis muscle activity - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left iliocostalis muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  6. Maximum left Iliocostalis muscle activity - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left iliocostalis muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  7. Maximum right Iliocostalis muscle activity - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right iliocostalis muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  8. Maximum right Iliocostalis muscle activity - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right iliocostalis muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  9. Left longissimus muscle activity (AUC) - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left Longissimus muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  10. Left longissimus muscle activity (AUC) - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left Longissimus muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  11. Right longissimus muscle activity (AUC) - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right Longissimus muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  12. Right longissimus muscle activity (AUC) - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right Longissimus muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  13. Maximum left longissimus muscle activity - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left Longissimus muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  14. Maximum left longissimus muscle activity - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left Longissimus muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  15. Maximum right longissimus muscle activity - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right Longissimus muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  16. Maximum right longissimus muscle activity - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right Longissimus muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  17. Left external oblique muscle activity (AUC) - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left external oblique muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  18. Left external oblique muscle activity (AUC) - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left external oblique muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  19. Right external oblique muscle activity (AUC) - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right external oblique muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  20. Right external oblique muscle activity (AUC) - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right external oblique muscle. After filtering the muscle signal, the average area under the curve during one gait cycle will be calculated and reported for each back brace as a percentage for the area under the curve when subjects were not wearing a back brace.

  21. Maximum left external oblique muscle activity - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left external oblique muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  22. Maximum left external oblique muscle activity - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the left external oblique muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  23. Maximum right external oblique muscle activity - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right external oblique muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  24. Maximum right external oblique muscle activity - stair ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right external oblique muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  25. Right rectus abdominus muscle activity (AUC) - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right rectus abdominus muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  26. Right rectus abdominus muscle activity (AUC) - stair aseent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right rectus abdominus muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  27. Maximum right rectus abdominus muscle activity - walking

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right rectus abdominus muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

  28. Maximum right rectus abdominus muscle activity - ascent

    Time frame: Day 1

    A low profile surface electrode will be used to record the electromyographic activity of the right rectus abdominus muscle. After filtering the muscle signal, the maximum value during one gait cycle will be calculated and reported for each back brace as a percentage for the maximum value when subjects were not wearing a back brace.

Sponsors and collaborators

Lead sponsor

More Foundation

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2022
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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