Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2

NCT ID: NCT05359705

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2021-10-16

Brief Summary

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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).

Detailed Description

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Conditions

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Back Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy subjects

Healthy subjects who meet the Inclusion/Exclusion.

Group Type EXPERIMENTAL

DJO 456

Intervention Type DEVICE

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

Aspen 456

Intervention Type DEVICE

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

DJO 464

Intervention Type DEVICE

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

Aspen 464

Intervention Type DEVICE

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

Interventions

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DJO 456

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

Intervention Type DEVICE

Aspen 456

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

Intervention Type DEVICE

DJO 464

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

Intervention Type DEVICE

Aspen 464

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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More Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MORE Foundation

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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4051

Identifier Type: -

Identifier Source: org_study_id

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