10 February 2015

1. Does the system assess shoulder and back range of movement in all directions? what are the reliability and accuracy of these measurements?

Yes in all directions. The accuracy is aprox 2-5 cm and 2-5 degrees, although these are relative measurements (outside body volume for the back). The shoulder is actually hand vs shoulder location.

2. Does reporting is concerned only with joints range or other measures are included? Does it correct errors caused by possible substitution movements?

Every exercise is generating motion data. The accuracy of isolated movements (for example abduction in one joint: hip or shoulder or knee, shoulder flexion) is much better than the accuracy of complex movements (squats, lunges). Still the results can be compared over time for one patient.

The substitution / compensation movements are corrected but also it depends on an exercise and difficulty level and patient’s movements characteristics.

In general the data have to be interpreted by a physiotherapist but give a great incentive of a measuring device.

3. Can patient data be stored?

Yes, they are automaticaly stored and can be easily compared between any 2 or 3 sessions over time. The reports are graphical and enable easy comparison as well as progress tracking.

Still the data need to be interpreted, since FysioGaming is not a measuring device.

4. Regarding the 30 levels of difficulty: how does progression of difficult take place? Does it depend on increasing speed, range, repetitions or others? Can the therapist customize progression based on patient’s needs? 

Yes, the therapist is setting up a level and can set up different level for different exercises so fully personalize it.

The higher difficulty level increases the speed and technical difficulty. Pls refer to the manual pages 4-5

5. Is it possible to purchase the software alone without the specified the hardware?

YES, the pricing depends on Meden Inmed in this case.

6. What are the elements included in patient progress report, exercise statistical report and detailed motion reports?

There is too many to specify them in writing… perhaps we should provide you with an online demo?

7. Does the system track face or just extremities and trunk?

Extremities and trunk.

8. What is the minimal and maximal working distance for the sensor?

Please refer to the manual page 6.

9. Are there any previous international scientific publications that support the use of Fysiogaming system?

We did pilot studies with the University in Ghent and Den Hague and a research with Poznan University of Physical therapy.

We are waiting for the publications.

11. Is this system approved by any European countries other than the Netherlands?

The system is approved according to the Medical Devices Directive, which means it’s approved automatically across the European Union.

In other markets it enables easy certification.

12. Is this system meets the CE regulations?

The system is class I medical device, approval in Dutch attached as well as the Declaration of Conformity.