Usability Study for the Beactive Brace Instructions for Use

NCT02474732 | Completed

• 1 other identifier: C15-0419
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

FDA requires that the user's guide be provided with any over-the-counter (OTC) medical device. It is beneficial to demonstrate that the user's guide for a new medical device is broadly comprehensible where the device will be provided without prescription and direct physician counseling. Therefore, a population of subjects will be tested to determine whether they can properly use the BeActive Brace device after reading the user's guide.

Conditions

Lower Back Pain

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Correctly Following Instructions for Use

  Subjects were observed as they read the instructions for use and applied the Beactive(r) Brace.

  Five minutes

Study Arms (1)

Usability

OTHER

Determine if the subjects are able to understand and follow the directions to apply the Beactive Brace.

Device: Beactive(r) Brace

Interventions

Beactive(r) Brace DEVICE

Determine if the subjects are able to understand and follow the directions to apply the Beactive Brace.

Usability

Eligibility Criteria

• Age: 22 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be male or female, between the ages of ages 22 to 79 years (inclusive);
• Subjects must understand and execute an Individual Consent Form (ICF) and complete a Medical History Form;
• Subjects must be in general good health, except for back pain;
• Subjects must have a history of lower back pain with radiating pain down the leg;
• Subjects must have completed the 10th grade and must be able to read and comprehend English;
• Subjects must be willing to report any medications taken during the trial and refrain from taking medication that might reduce back pain; and
• Subjects must be considered reliable and capable of following directions.

You may not qualify if:

• Subjects in ill health or taking medication, other than birth control, which could influence the purpose,integrity or outcome of the trial; or
• Subjects having any visible skin disease, which might be confused with a skin reaction from the test material.

Sponsors & Collaborators

• Benjamin L. England and Associates, LLC: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Braces

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Michael Caswell

  Consumer Product Testing Compahy, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 18, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share