Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

More Foundation

Status: Completed

Conditions: Back Injuries

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05359705

4051

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Healthy subjects

Experimental group

Description:

Healthy subjects who meet the Inclusion/Exclusion.

Treatment:

Device: DJO 456

Device: DJO 464

Device: Aspen 464

Device: Aspen 456