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Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

Primary Purpose

Back Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DJO 456
Aspen 456
DJO 464
Aspen 464
Sponsored by
More Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Back Injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • MORE Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy subjects

Arm Description

Healthy subjects who meet the Inclusion/Exclusion.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 13, 2022
Last Updated
May 4, 2022
Sponsor
More Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05359705
Brief Title
Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2
Official Title
Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
October 16, 2021 (Actual)
Study Completion Date
October 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
More Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Injuries

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Healthy subjects who meet the Inclusion/Exclusion.
Intervention Type
Device
Intervention Name(s)
DJO 456
Intervention Description
Data will be recorded while subjects wear a 456 back brace manufactured by DJO Global
Intervention Type
Device
Intervention Name(s)
Aspen 456
Intervention Description
Data will be recorded while subjects wear a 456 back brace manufactured by Aspen Medical Products
Intervention Type
Device
Intervention Name(s)
DJO 464
Intervention Description
Data will be recorded while subjects wear a 464 back brace manufactured by DJO Global
Intervention Type
Device
Intervention Name(s)
Aspen 464
Intervention Description
Data will be recorded while subjects wear a 464 back brace manufactured by Aspen Medical Products
Primary Outcome Measure Information:
Title
Flexion - Sagittal plane
Description
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
Title
Extension - Sagittal plane
Description
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
Title
Range of motion - Frontal plane
Description
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
Title
Range of motion - Transverse plane
Description
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
Title
Rotation angle while looking over shoulder
Description
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
Title
Range of motion in the sagittal plane when rising from a chair
Description
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
Title
Range of motion in the sagittal plane when returning to a seated position
Description
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.
Time Frame
Day 1
Title
Flexion angle in the sagittal plane when touching right hallux in a seated position
Description
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
Title
Flexion angle in the sagittal plane when picking an object up from the floor
Description
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
Title
Range of motion in the sagittal plane while walking on a level surface
Description
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
Title
Range of motion in the frontal plane while walking on a level surface
Description
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
Title
Range of motion in the transverse plane while walking on a level surface
Description
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
Title
Range of motion in the sagittal plane while ascending stairs.
Description
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
Title
Range of motion in the sagittal plane while descending stairs.
Description
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
Title
Range of motion in the frontal plane while ascending stairs.
Description
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
Title
Range of motion in the frontal plane while descending stairs.
Description
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
Title
Range of motion in the transverse plane while ascending stairs.
Description
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
Title
Range of motion in the transverse plane while descending stairs.
Description
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
Title
Flexion angle in the sagittal plane when reaching forwards and around an object with their right hand.
Description
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
Title
Flexion angle in the sagittal plane when reaching forwards and around an object with their left hand.
Description
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
Time Frame
Day 1
Title
Lateral angle in the frontal plane when reaching forwards and around an object with their right hand.
Description
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
Title
Lateral angle in the frontal plane when reaching forwards and around an object with their left hand.
Description
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
Time Frame
Day 1
Title
Rotation angle in the transverse plane when reaching forwards and around an object with their right hand.
Description
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
Title
Rotation angle in the transverse plane when reaching forwards and around an object with their left hand.
Description
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
Time Frame
Day 1
Title
Flexion angle in the sagittal plane when reaching when reach down to pick up a suitcase
Description
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
Title
Lateral angle in the frontal plane when reaching when reach down to pick up a suitcase
Description
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
Title
Rotation angle in the transverse plane when reaching when reach down to pick up a suitcase
Description
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 Outcome Measure Information:
Title
Comfort
Description
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
Title
Trunk stiffness and damping - front angle
Description
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
Title
Trunk stiffness and damping - front angular velocity
Description
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
Title
Trunk stiffness and damping - front angular acceleration
Description
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
Title
Trunk stiffness and damping - back angle
Description
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
Title
Trunk stiffness and damping - back angular velocity
Description
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
Title
Trunk stiffness and damping - back angular acceleration
Description
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
Title
Trunk stiffness and damping - right side angle
Description
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
Title
Trunk stiffness and damping - right side angular velocity
Description
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
Title
Trunk stiffness and damping - right side angular acceleration
Description
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
Other Pre-specified Outcome Measures:
Title
Left Iliocostalis muscle activity (AUC) - walking
Description
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.
Time Frame
Day 1
Title
Left Iliocostalis muscle activity (AUC) - stair ascent
Description
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.
Time Frame
Day 1
Title
Right Iliocostalis muscle activity (AUC) - walking
Description
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.
Time Frame
Day 1
Title
Right Iliocostalis muscle activity (AUC) - stair ascent
Description
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.
Time Frame
Day 1
Title
Maximum left Iliocostalis muscle activity - walking
Description
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.
Time Frame
Day 1
Title
Maximum left Iliocostalis muscle activity - stair ascent
Description
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.
Time Frame
Day 1
Title
Maximum right Iliocostalis muscle activity - walking
Description
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.
Time Frame
Day 1
Title
Maximum right Iliocostalis muscle activity - stair ascent
Description
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.
Time Frame
Day 1
Title
Left longissimus muscle activity (AUC) - walking
Description
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.
Time Frame
Day 1
Title
Left longissimus muscle activity (AUC) - stair ascent
Description
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.
Time Frame
Day 1
Title
Right longissimus muscle activity (AUC) - walking
Description
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.
Time Frame
Day 1
Title
Right longissimus muscle activity (AUC) - stair ascent
Description
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.
Time Frame
Day 1
Title
Maximum left longissimus muscle activity - walking
Description
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.
Time Frame
Day 1
Title
Maximum left longissimus muscle activity - stair ascent
Description
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.
Time Frame
Day 1
Title
Maximum right longissimus muscle activity - walking
Description
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.
Time Frame
Day 1
Title
Maximum right longissimus muscle activity - stair ascent
Description
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.
Time Frame
Day 1
Title
Left external oblique muscle activity (AUC) - walking
Description
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.
Time Frame
Day 1
Title
Left external oblique muscle activity (AUC) - stair ascent
Description
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.
Time Frame
Day 1
Title
Right external oblique muscle activity (AUC) - walking
Description
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.
Time Frame
Day 1
Title
Right external oblique muscle activity (AUC) - stair ascent
Description
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.
Time Frame
Day 1
Title
Maximum left external oblique muscle activity - walking
Description
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.
Time Frame
Day 1
Title
Maximum left external oblique muscle activity - stair ascent
Description
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.
Time Frame
Day 1
Title
Maximum right external oblique muscle activity - walking
Description
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.
Time Frame
Day 1
Title
Maximum right external oblique muscle activity - stair ascent
Description
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.
Time Frame
Day 1
Title
Right rectus abdominus muscle activity (AUC) - walking
Description
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.
Time Frame
Day 1
Title
Right rectus abdominus muscle activity (AUC) - stair aseent
Description
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.
Time Frame
Day 1
Title
Maximum right rectus abdominus muscle activity - walking
Description
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.
Time Frame
Day 1
Title
Maximum right rectus abdominus muscle activity - ascent
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
MORE Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

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