Call for Subjects – Helios Brace Research Study

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Call for Subjects – Helios Brace Research Study

Subjects with Charcot-Marie-Tooth disease who plan on being fitted

with the Helios Brace by Ortho Rehab Designs of Las Vegas are needed

for a research study on the performance of the brace. The University

of Nevada, Las Vegas (UNLV), needs approximately 20 subjects

diagnosed with Charcot-Marie-Tooth disease who, over the next ten

months, plan to be fitted with the Helios brace by Ortho Rehab

Designs for the first time. The study will be undertaken at the

University of Nevada, Las Vegas. It is being funded by the University

of Nevada, Las Vegas, the Hereditary Neuropathy Foundation, and Ortho

Rehab Designs. Subjects must be patients of Ortho Rehab Designs.

The research will involve collecting data on gait, balance, muscle

strength, and ground reaction force at the time patients are in Las

Vegas to be fitted for the brace prior to its delivery. Data will be

collected again at UNLV in Las Vegas after the braces have been

delivered and subjects have had eight to ten weeks to adapt to them.

During the follow-up visit to UNLV, six of the twenty subjects will

be selected for additional data collection involving the use of

motion capture equipment, and two of these six subjects will be

fitted with a duplicate pair of experimental braces instrumented for

purposes of measuring the engineering behavior of the brace.

The Hereditary Neuropathy Foundation and UNLV will cover the costs of

travel for the follow-up visit to Las Vegas. The study grant is not

able to cover the cost of the Helios braces or the travel costs for

initial fitting.

To participate in the study, subjects must

1. Meet the eligibility requirements of Ortho Rehab Designs for

fitting the Helios (subjects for whom Ortho Rehab Designs determines

that the Helios brace poses health or safety risks and declines to

fit the brace will not be included in the study) and plan to obtain

the brace;

2. Have bilateral foot drop;

3. Be age 18 or over;

4. Be able to walk, without risk of falling, a distance of at least

20 feet both with and without any kind of brace or orthosis, and

subjects selected for motion capture must be able to walk a distance

of 100 feet (walking with a cane or within parallel bars or

accompanied by another individual to assist with balance is

acceptable);

5. Have no physical conditions such as heart disease, respiratory

impairment or other condition which would place a subject at risk

from the walking activity which will be required during data

collection;

6. Have no open sores or wounds or recent surgery on the legs or feet

at the times of data collection; and

7. Agree to schedule a return visit to UNLV on a weekday after

completing the adaptation instructions prescribed by Ortho Rehab

Designs (this will be approximately eight to ten weeks after

beginning the adaptation process, and will involve one day of data

collection and up to two days of travel).

Interested individuals should contact S. Neumann, PhD, PE, CP

at the University of Nevada, Las Vegas (702 895-1072, or

.Neumann@...) for further information.