Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

Back Injuries Clinical Trial

Official title:

Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05359705
• Other study ID #: 4051
• Status: Completed
• Phase: N/A
• Start date: June 23, 2021
• Est. completion date: October 16, 2021

Study information

• Verified date: May 2022
• Source: More Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 16, 2021
• Est. primary completion date: October 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Injuries

Intervention

Device:
• DJO 456
Data will be recorded while subjects wear a 456 back brace manufactured by DJO Global
• Aspen 456
Data will be recorded while subjects wear a 456 back brace manufactured by Aspen Medical Products
• DJO 464
Data will be recorded while subjects wear a 464 back brace manufactured by DJO Global
• Aspen 464
Data will be recorded while subjects wear a 464 back brace manufactured by Aspen Medical Products

Locations

Country	Name	City	State
United States	MORE Foundation	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
More Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Left Iliocostalis muscle activity (AUC) - walking	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.	Day 1
Other	Left Iliocostalis muscle activity (AUC) - stair ascent	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.	Day 1
Other	Right Iliocostalis muscle activity (AUC) - walking	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.	Day 1
Other	Right Iliocostalis muscle activity (AUC) - stair ascent	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.	Day 1
Other	Maximum left Iliocostalis muscle activity - walking	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.	Day 1
Other	Maximum left Iliocostalis muscle activity - stair ascent	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.	Day 1
Other	Maximum right Iliocostalis muscle activity - walking	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.	Day 1
Other	Maximum right Iliocostalis muscle activity - stair ascent	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.	Day 1
Other	Left longissimus muscle activity (AUC) - walking	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.	Day 1
Other	Left longissimus muscle activity (AUC) - stair ascent	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.	Day 1
Other	Right longissimus muscle activity (AUC) - walking	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.	Day 1
Other	Right longissimus muscle activity (AUC) - stair ascent	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.	Day 1
Other	Maximum left longissimus muscle activity - walking	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.	Day 1
Other	Maximum left longissimus muscle activity - stair ascent	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.	Day 1
Other	Maximum right longissimus muscle activity - walking	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.	Day 1
Other	Maximum right longissimus muscle activity - stair ascent	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.	Day 1
Other	Left external oblique muscle activity (AUC) - walking	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.	Day 1
Other	Left external oblique muscle activity (AUC) - stair ascent	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.	Day 1
Other	Right external oblique muscle activity (AUC) - walking	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.	Day 1
Other	Right external oblique muscle activity (AUC) - stair ascent	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.	Day 1
Other	Maximum left external oblique muscle activity - walking	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.	Day 1
Other	Maximum left external oblique muscle activity - stair ascent	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.	Day 1
Other	Maximum right external oblique muscle activity - walking	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.	Day 1
Other	Maximum right external oblique muscle activity - stair ascent	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.	Day 1
Other	Right rectus abdominus muscle activity (AUC) - walking	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.	Day 1
Other	Right rectus abdominus muscle activity (AUC) - stair aseent	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.	Day 1
Other	Maximum right rectus abdominus muscle activity - walking	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.	Day 1
Other	Maximum right rectus abdominus muscle activity - ascent	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.	Day 1
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1