Brief technical description of the equipment tested and its scope of use:

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1 Ministry of Defence of the Russian Federation "PV Mandryk Clinical Medical Centre for Research and Teaching" public federal establishment of the Ministry of Defence of the Russian Federation B. Olenia 8A, 0704 Moscow 7/0/203 No. 272 "APPROVED" by the head of the "PV Mandryk Clinical Medical Centre for Research and Teaching" FKU (public federal establishment) of the Ministry of Defence of the Russian Federation, a member of the Academy of Medical Sciences of the Russian Federation, Distinguished Master of Sciences of the Russian Federation, Doctor of Medicine, professor, Medical Inspector (Brigadier General of the Medical Service for the Armed Forces) VB Simonenko OPINION of the "PV Mandryk Clinical Medical Centre for Research and Teaching" FKU of the Ministry of Defence of the Russian Federation on the operation of the "Satisform" (France) programmable automated biomechanical device Since 2/2/202, the "PV Mandryk Clinical Medical Centre for Research and Teaching" public federal establishment of the Ministry of Defence of the Russian Federation has had, in its physiotherapy office in the rehabilitation department, a "Satisform" (France) programmable automated biomechanical device, intended for dynamic stretching of the spinal column for the prevention and treatment of back conditions. This apparatus is there on a trial basis, pursuant to a letter from the director of the Central Directorate of Healthcare Services of the Ministry of Defence of the Russian Federation. Objective of the clinical trial: to assess the suitability of using the above-mentioned apparatus in medical practice in healthcare services for the armed forces. Documents on which the trial was based: Letter from the director of the Central Directorate of Health Services of the Ministry of Defence of the Russian Federation 6/2/3/594 of 26/0/202. Certificate of compliance ROSS FR.IM4.D022 of 08/05/2 (issuing authority: "Centre for Certifications and Declarations" SRL ROSS RU.000.IM4) Certificate of registration FSZ 200/06247 of 5/02/200 issued by the Federal Service for Surveillance in Healthcare and Social Development. Items that were made available for the clinical trial: A "Satisform programmable automated biomechanical device," with its accessories; A complete technical dossier for the apparatus; A user manual for the apparatus; and A clinical practice recommendation entitled "Dynamic stretching of the spinal column as part of medical rehabilitation programmes for patients suffering from

2 back conditions incorporating the use of the Satisform programmable automated biomechanical device" (approved by the Scientific Council of the Russian Academy of Postdoctoral Teaching in Medicine, protocol 3 of 22/03/20). Brief technical description of the equipment tested and its scope of use: The "Satisform" programmable automated biomechanical device is intended for use in sessions of dynamic stretching of the spinal column for purposes of treatment, prevention and fitness. The method of dynamic stretching of the spine is based on the combined use of mechanical rocking motions in a horizontal (sagittal) plane and simultaneous application of traction along the longitudinal axis of the spinal column (vertical plane). Dynamic rocking motions of a certain range, within the limits of a physiological frequency of change in muscle tone (contraction relaxation), combined with simultaneous stretching of the spine, help relax the paravertebral muscles and reduce pain symptoms around the spinal column. The main indications for stretching of the spine are: lumbar spine conditions, prolonged vertical loads (including gravity loads) applied to the spinal column, and dysfunction of the spinal column's own motor activity. The intensity of the stretching is essentially determined based on the nature of the disorders observed: traction is minimal when the goal is merely to relieve a spine subjected to a vertical load, and may go up to a considerable value, in proportion to the patient's body weight. The fundamental difference between the "Satisform" programmable automated biomechanical device and other technical stretching devices lies in the possibility it offers of simultaneously performing stretching and rocking of the spine, taking into account the individual characteristics (including anthropometric characteristics) of the patient (sex, age, weight and height). The force applied may vary from a few hundred grams to several dozen kilograms. Simultaneous application of traction and rocking forces produces alternating cycles of contraction/relaxation of the paravertebral muscles and deep muscles of the back. This not only amplifies the treatment's beneficial effect, but also actively helps prevent back pain. Main technical characteristics and parameters: Power supply Power consumption Mode of operation Intensity of stretching of the spinal column of dynamic rocking Overall dimensions Maximum body weight (kg) Session duration Mean time between failures Nominal voltage: V : 50 Hz 2 A 500 W Intermittent 0-45 kg 0.5- Hz 290 x 20 x 80 mm 60 kg -5 min,500 hours Characteristics of the main programmes: Low-intensity programmes, used in initial stages (gentle mode)

3 Programme 0 Rocking only Rocking and stretching Rocking and stretching, legs raised for 4 seconds Rocking and stretching, legs raised for 5 seconds 0.5 Medium-intensity programmes, used in intermediate stages (gentle training mode) Programme 5 0 Rocking only, higher frequency 6 0 Simultaneous rocking and stretching 7 0 Rocking and stretching, legs raised for 4 seconds 8 0 Rocking and stretching, legs raised for 5 seconds High-intensity programmes, used in final stages (vigorous training mode) Programme 9 0 Rocking and double stretching 0 0 Rocking and double stretching, legs raised for 4 seconds 0 Rocking and double stretching, legs raised for 5 seconds 2 0 Rocking and double stretching, legs raised for 20 seconds Special programmes, used according to the patient's individual indications, during gentle and vigorous training phases Programme Type of programme 3 5 stretches Low-intensity stretches, legs raised for 4 seconds Low-intensity stretches Mediumintensity 6 5 stretches, legs raised for 4 seconds Mediumintensity Results of the study: A group of 30 patients (5 men and 5 women) suffering from degenerative conditions of the lumbar sacral spine benefitted from treatment based on the use of the "Satisform" programmable automated biomechanical device. Ten patients had radicular syndrome. Most patients (67%) were 50 to 62 years of age, while the rest of the group belonged to

4 various age groups: 7% were between 23 and 33 years of age, 0% were between 40 and 45 years of age, and 6% were between 65 and 72 years of age. Patient selection was based on the clinical picture: patient complaints, objective status of the spinal column and entire musculoskeletal system, neurological status, and results of MRI examinations. The control group consisted of 30 patients 50 to 65 years of age, selected according to the same criteria. The dynamic stretching treatment protocol consisted of 8 to 2 sessions of a duration of 5 to 5 minutes administered every other day. Physical rehabilitation sessions were performed in a context of drug therapy based on anti-inflammatory agents and on medicines to improve metabolism and promote tissue regeneration. The dynamic assessment of the efficacy of the traction therapy used clinical examinations, tests to assess spine motor function (mobility and range of motion), an assessment of pain syndrome on a VAS scale, and measurements of the patient's height. On completion of the protocol, the results were interpreted according to commonly accepted statistical criteria. An assessment was performed before the start and after the end of the dynamic stretching treatment. The subjective assessment by all patients showed that the treatment had a satisfactory level of comfort, regardless of pain location (lumbar sacral spine, legs or buttocks). Compared to the start of the treatment, spinal column extension and motor function indicators showed significant improvement versus the physical rehabilitation programme without dynamic stretching (around 30%). Among the patients treated, 2 no longer observed any pain after 3 to 4 sessions, 3 reported reduced pain around the 2th session and all others experienced a progressive reduction in pain starting from the 0th session. All reported a feeling of comfort and lightness in the lumbar spine at the end of a session. Therefore, we find that the use of the apparatus improves the management of patients suffering from back conditions. Throughout the trial, the "Satisform" programmable automated biomechanical device operated reliably, thus offering the possibility of management under good conditions. In the course of the trial, the apparatus was observed to have the following qualities: ) The apparatus allows effective management through several modes of operation (dynamic stretching, stretching only, and dynamic rocking only). It is quite compact, and therefore it may be used in tight spaces, physiotherapy offices and fitness facilities. 2) The control interface allows the mode of operation and session duration to be adjusted and controlled. The apparatus is equipped with sensors, operational indicators and an emergency-stop button, which allows it to be used reliably and safely. 3) The apparatus (once connected to the power grid) is extremely easy to use. All that has to be done is to enter the patient's parameters and select the mode of operation, which is very clearly indicated on the liquid-crystal display, then press the start button. 4) The accessories for supporting the legs used during sessions are ergonomic and easy to clean and disinfect. 5) The user manual and clinical practice recommendation for use by physicians are well detailed and clearly illustrated. 6) The patients assessed the "Satisform" programmable automated biomechanical device treatment sessions as very effective.

5 Drawbacks: The apparatus does not allow the anthropometric data and mode of operation for a given patient to be saved, which requires this data to be entered at each session. Overall, the "Satisform" programmable automated biomechanical device is practical, reliable and easy to use, and it meets the requirements for medical use. The continued use of the method of dynamic stretching of the spine is justified from a practical point of view. There is no fundamental reservation to be put forward regarding the use of the apparatus. CONCLUSION: The clinical trial and implementation of the method of dynamic stretching of the spinal column that we conducted led us to conclude that the "Satisform" automated biomechanical device, of French manufacture, may be recommended for use at healthcare establishments for the armed forces, as well as in medical practice at healthcare and rehabilitation/fitness establishments in the Russian Federation. Head of the physiotherapy office in the rehabilitation department Head of the rehabilitation department Head of the physiotherapy department IN Makarova LR Gareeva AU Gussev