Clinical trial NCT05359705: 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
Overall status: COMPLETED
Phase: NA
Conditions: Back Injuries
Lead sponsor: More Foundation
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Flexion - Sagittal plane
timeFrame: Day 1
measure: Extension - Sagittal plane
timeFrame: Day 1
measure: Range of motion - Frontal plane
timeFrame: Day 1
measure: Range of motion - Transverse plane
timeFrame: Day 1
measure: Rotation angle while looking over shoulder
timeFrame: Day 1
measure: Range of motion in the sagittal plane when rising from a chair
timeFrame: Day 1
measure: Range of motion in the sagittal plane when returning to a seated position
timeFrame: Day 1
measure: Flexion angle in the sagittal plane when touching right hallux in a seated position
timeFrame: Day 1
measure: Flexion angle in the sagittal plane when picking an object up from the floor
timeFrame: Day 1
measure: Range of motion in the sagittal plane while walking on a level surface
timeFrame: Day 1
measure: Range of motion in the frontal plane while walking on a level surface
timeFrame: Day 1
measure: Range of motion in the transverse plane while walking on a level surface
timeFrame: Day 1
measure: Range of motion in the sagittal plane while ascending stairs.
timeFrame: Day 1
measure: Range of motion in the sagittal plane while descending stairs.
timeFrame: Day 1
measure: Range of motion in the frontal plane while ascending stairs.
timeFrame: Day 1
measure: Range of motion in the frontal plane while descending stairs.
timeFrame: Day 1
measure: Range of motion in the transverse plane while ascending stairs.
timeFrame: Day 1
measure: Range of motion in the transverse plane while descending stairs.
timeFrame: Day 1
measure: Flexion angle in the sagittal plane when reaching forwards and around an object with their right hand.
timeFrame: Day 1
measure: Flexion angle in the sagittal plane when reaching forwards and around an object with their left hand.
timeFrame: Day 1
measure: Lateral angle in the frontal plane when reaching forwards and around an object with their right hand.
timeFrame: Day 1
measure: Lateral angle in the frontal plane when reaching forwards and around an object with their left hand.
timeFrame: Day 1
measure: Rotation angle in the transverse plane when reaching forwards and around an object with their right hand.
timeFrame: Day 1
measure: Rotation angle in the transverse plane when reaching forwards and around an object with their left hand.
timeFrame: Day 1
measure: Flexion angle in the sagittal plane when reaching when reach down to pick up a suitcase
timeFrame: Day 1
measure: Lateral angle in the frontal plane when reaching when reach down to pick up a suitcase
timeFrame: Day 1
measure: Rotation angle in the transverse plane when reaching when reach down to pick up a suitcase
timeFrame: Day 1
Secondary outcomes:
measure: Comfort
timeFrame: Day 1
measure: Trunk stiffness and damping - front angle
timeFrame: Day 1
measure: Trunk stiffness and damping - front angular velocity
timeFrame: Day 1
measure: Trunk stiffness and damping - front angular acceleration
timeFrame: Day 1
measure: Trunk stiffness and damping - back angle
timeFrame: Day 1
measure: Trunk stiffness and damping - back angular velocity
timeFrame: Day 1
measure: Trunk stiffness and damping - back angular acceleration
timeFrame: Day 1
measure: Trunk stiffness and damping - right side angle
timeFrame: Day 1
measure: Trunk stiffness and damping - right side angular velocity
timeFrame: Day 1
measure: Trunk stiffness and damping - right side angular acceleration
timeFrame: Day 1
Other outcomes:
measure: Left Iliocostalis muscle activity (AUC) - walking
timeFrame: Day 1
measure: Left Iliocostalis muscle activity (AUC) - stair ascent
timeFrame: Day 1
measure: Right Iliocostalis muscle activity (AUC) - walking
timeFrame: Day 1
measure: Right Iliocostalis muscle activity (AUC) - stair ascent
timeFrame: Day 1
measure: Maximum left Iliocostalis muscle activity - walking
timeFrame: Day 1
measure: Maximum left Iliocostalis muscle activity - stair ascent
timeFrame: Day 1
measure: Maximum right Iliocostalis muscle activity - walking
timeFrame: Day 1
measure: Maximum right Iliocostalis muscle activity - stair ascent
timeFrame: Day 1
measure: Left longissimus muscle activity (AUC) - walking
timeFrame: Day 1
measure: Left longissimus muscle activity (AUC) - stair ascent
timeFrame: Day 1
measure: Right longissimus muscle activity (AUC) - walking
timeFrame: Day 1
measure: Right longissimus muscle activity (AUC) - stair ascent
timeFrame: Day 1
measure: Maximum left longissimus muscle activity - walking
timeFrame: Day 1
measure: Maximum left longissimus muscle activity - stair ascent
timeFrame: Day 1
measure: Maximum right longissimus muscle activity - walking
timeFrame: Day 1
measure: Maximum right longissimus muscle activity - stair ascent
timeFrame: Day 1
measure: Left external oblique muscle activity (AUC) - walking
timeFrame: Day 1
measure: Left external oblique muscle activity (AUC) - stair ascent
timeFrame: Day 1
measure: Right external oblique muscle activity (AUC) - walking
timeFrame: Day 1
measure: Right external oblique muscle activity (AUC) - stair ascent
timeFrame: Day 1
measure: Maximum left external oblique muscle activity - walking
timeFrame: Day 1
measure: Maximum left external oblique muscle activity - stair ascent
timeFrame: Day 1
measure: Maximum right external oblique muscle activity - walking
timeFrame: Day 1
measure: Maximum right external oblique muscle activity - stair ascent
timeFrame: Day 1
measure: Right rectus abdominus muscle activity (AUC) - walking
timeFrame: Day 1
measure: Right rectus abdominus muscle activity (AUC) - stair aseent
timeFrame: Day 1
measure: Maximum right rectus abdominus muscle activity - walking
timeFrame: Day 1
measure: Maximum right rectus abdominus muscle activity - ascent
timeFrame: Day 1
Locations:
city: Phoenix
country: United States
facility: MORE Foundation
state: Arizona
Study officials:
References: