Frequently Asked Questions
Copyright © 2010 Andante Medical Devices, Inc. All Rights Reserved.
1. What is SmartStep™? SmartStep™ is an innovative biofeedback and monitoring system
for lower limb rehabilitation. The system enables physical therapists and clinicians to
assess, treat and monitor patients who have compromised lower limb functions.

2. Which patients can benefit from SmartStep™? Post-operative orthopedic and trauma
patients; Patients who suffer from neurological impairment or disability; Sport injury
patients.

3. How does the SmartStep™ system work? SmartStep™ is composed of four integrated
elements: A flexible, lightweight, force-sensing insole A wireless portable, miniature
microprocessor control unit User-friendly software for gait analysis, display and long-term
storage of patient performance records Multimedia interactive training software The unique
SmartStep™ insole measures the force applied by the heel and forefoot of the affected
limb. The data is received and analyzed by the wireless miniature portable control unit
worn around the ankle. Data is transmitted to a computer running the SmartStep™
software, which also maintains patient medical records and functions as an assessment
and therapeutic tool. The interactive training software enables self training and exercise in
front of a multimedia display, increasing patient motivation and performance, and
improving the effectiveness of each therapy session.

4. How many insoles come with SmartStep and do they very in size? The SmartStep now
comes with five (5) insoles and vary is size from pediatric to adult (4.5-5.5, 6-7, 7.5-8.5,
8.5-10 and 10.5-11.5).

5. What does the SmartStep™ software analyze? The SmartStep™ software analyzes four
key gait parameters: Body Weight (BW) on the hind, fore and entire foot Heel-to-toe gait
pattern The gait cycle temporal characteristics: stance and swing duration, cadence, and
symmetry.

6. What kind of feedback does the SmartStep™ control unit provide? SmartStep's control
unit can be programmed to provide the patient with real-time auditory indications of
correct or incorrect gait performance as per the specific patient’s prescribed regime.

7. How is SmartStep™ patient data stored? All data, including a full list of all patient
sessions and relevant information for each, is automatically saved in the patient’s file for
easy access.

8. How does SmartStep™ help clinicians? The system is an accurate tool that helps
clinicians and physical therapists quantify patient performance, determine therapy goals
and monitor patient progress. SmartStep™ also helps clinicians determine: The type of
facilitation desired in the treatment The degree of physical independence The safest level
of ambulation

9. What types of treatment can SmartStep™ offer? Gait training exercises using auditory
or visual display in different threshold levels as per patient ability and medical prescription
Gait training exercises with interactive multimedia display games

10. What is SmartStep Clinical Interactive Training Program? This new proprietary software
consists of a ski game, which engages patients in a total interactive play. Limits are set by
the physical therapists to enable their patients to reach their targeted weight bearing
goals while swooshing and jumping through the Alps. Not only will patients gain the
confidence they need to reach their optimal functional performance, but they will also have
fun doing it. The program will increase patient motivation, performance and improve the
effectiveness of each therapy session.

11. How does using SmartStep™ assist in rehabilitation and re-education? One of the
most significant re-education stages is the ‘fixation’ or practice stage. At this vital
juncture, the system facilitates: Self-treatment and exercise with multiple repetitions
Instantaneous visual and auditory feedback throughout the entire exercise Practice in
different environments, various platforms and various conditions The interactive training
software enables self training and exercise in front of a multimedia display, thus
increasing patient motivation and performance, and increasing the effectiveness of each
therapy session.

12. How were SmartStep’s results validated? Results of an analysis of SmartStep™ vs.
force plate concluded that the overall accuracy of the SmartStep™ was statistically
significant (p=0.004) with a high level of correlation (R²=0.907). Analysis of the
SmartStep™ vs. Gaitmate showed a high correlation with Gaitmate measurements time
interval measurements for the Stance/ Swing/ Cycle Time (R²=0.996/0.995/0.997
respectively) and resulted in a relatively small standard error between methods.

13.What clinical studies have been done using SmartStep™? To date, clinical studies using
SmartStep™ include: “Learning partial weight bearing using a new body-weight measuring
system” “Validation of a new body-weight measuring system” “Pilot Study- Gait
rehabilitation following CRPS” “Pilot Study- Gait rehabilitation following ACL reconstruction”
“In-patient short-term gait rehabilitation by means of new body-weight measuring
system” "The use of a new biofeedback insole weight-bearing measuring device in the
assessment and rehabilitation of soccer players: A case study review".

Presentations in PM&R conferences include: 1. Isakov E. , Avni A., Gait rehabilitation by
means of a new body weight measuring system, 8th Congress of European Federation for
research in Rehabilitation (EFRR) June 13-17th 2004, Ljubljana. 2. Avni A., Isakov E. , In-
patient short-term gait rehabilitation by means of a new body weight measuring system,
5th Mesiterranean Congress of Physical Rehabilitaion Medicine, Sep. 30th – Oct 4th 2004,
Antalya. 3. Burger, Helena; Rudolf, Marko; Drole, Simon: Use of SmartStep Biofeedback  
for Gait Training in Stroke Patients and Amputees, 6th Mediterranean Congress of PRM,
October 18-21, 2006. 4. Isakov E, Gait Rehabilitation: A new biofeedback device for
monitoring and enhancing weight bearing over the affected lower limb. Europa
Medicophysica 2006, 42, 1-2. 5. Hershoko E., Tauber C., Carmeli E.: Biofeedback Versus
Physiotherapy in Patients With Partial Weight-Bearing. The American Journal
of Orthopedics, May 2008, E92-E96.