Functional Gait Therapy

Functional Robotic Gait Therapy

Make: Hocoma AG

Country of Orgin: Swizerland

General description of the unit

The unit should be equipped with an electrically driven gait orthosis operated in combination with a treadmill and body weight support system, controlled via PC.

The unit allows intensive gait training for patients with walking disabilities. 3.The unit enables training with a physiologic gait pattern.

The unit allows for training with active patient participation.

The unit is equipped with Augmented Performance Feedback in which specific gait exercises can be performed in a playful way.

The unit allows for training progression and ability matched challenge by reducing the support given to the patient gradually during the rehabilitation process.

The unit is equipped with assessment tools that analyze and document the patient’s progress.

The unit enables single therapist operation, is easy to use and relieves the therapist from the strain of guiding legs; so the therapist can focus on the optimum therapy shaping of the patient.

The safe and effective use of the unit has been proven in several pathologies like stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, Morbus Parkinson and in patients with cerebral palsy.

Evidence gathered from trials with the unit suggests that training with the unit results in gait quality improvement, sustained long term benefits, increase in aerobic capacity.   1.Robotic gait orthosis for adult

The unit should enable intensive gait training with a driven gait orthosis (gait-robot).

The gait robot should have electrical drives in knee and hip joints.

Ankle joint dorsiflexion should be supported passively by foot lifters.

The gait robot should be mechanically adjustable to individual patient anatomy.

The centers of rotation of the joints of the gait orthosis should be adjustable to be congruent with the centers of rotation of the patient’s joints for allowing optimum gait trajectories.

The upper leg length of the adult gait orthosis should be adjustable between 350 and 470 mm (distance from greater trochanter to knee joint cavity).

The pelvis width should be adjustable between at least 290-400 mm.

Module: Robotic gait orthosis for children (pediatric) the upper leg length of the pediatric gait orthosis should be adjustable between 210 and 350 mm (distance from greater trochanter to knee joint cavity).

The robotic gait orthosis for children and the robotic gait orthosis for adults should be easily and quickly exchangeable. 20.The pelvis depth should be adjustable for allowing intensive hip extension.

The unit should allow for individual settings of the patient population such as orthopedic asymmetries or genu varum, genu valgum.

The system should have an additional safety mechanism for the robotic gait orthosis for children with adaptable sensitivity values for the torque monitoring.

The Robotic gait orthosis for children should include pediatric harnesses.  

Treadmill

The unit should be equipped with a treadmill.

The treadmill should be operated together with the robotic gait orthosis for performing robotic gait training.

The speed of the treadmill during robotic gait training should be 0.5-3.2 km/h.

The maximal treadmill speed during robotic gait training can be increased to 4.0 km/h for research studies.

The treadmill should be operated stand-alone without orthosis for performing manual treadmill training.

The speed of the treadmill during manual gait training should be 0.5-10 km/h.

The surface of the treadmill should be (L x W) 140 x 65 cm.

Body Weight Support System

1.The unit is equipped with a patient lift to allow the lifting of a patient out of the wheel chair.

2.The unit allows static and dynamic unloading.

3.The unit allows static unloading of 135 kg.

4.The unit allows a continuous adjustable unloading of the patient’s weight between 0 and 85 kg in the dynamic condition. 5.During the dynamic condition, the unit promotes a physiological vertical movement of the body that enables sensory stimulation of the foot soles.

6.The unloading of the unit can be controlled via a remote control electronically.

7.The unloading of the unit can be controlled via user software. 8.The body weight system should have a built in electronic weighing scale and display in real time the approximate static patient weight and the dynamic weight support.

9.The unloading values set during a training session are stored in the software.

10.The unit allows to automatically keep the patient in the dynamic weight support condition.   Unit design

11.The unit should allow access of the patient in the wheel chair over a ramp.

12.The unit should be equipped with ergonomic handrails right and left that are reachable for the patient during installation and during training. 13.The handrails should be adjustable in width and height according to patient´s body dimensions. 14.The unit should allow easy handling for the therapist and have an open design so that the therapist can access the unit from the front and side. 15.The unit should have adjustable seats for the therapist. 16.The unit should allow a view on the patient walking in the device from at least one side, so that the therapist can observe the patient’s gait without visual obstacles. 17.The unit should be in a pleasant and compact design to allow the most comfortable training conditions and to not consume too much space of a room. 18.The design of the unit should follow the relevant functions needed.   User Interface and software

    The unit is equipped with an operating panel, 15’’ touch screen (Therapist screen).

20.The software of the unit allows for adjusting the operating speed. 21.The software of the unit allows for adjusting the range of motion of the hip and knee joints individually for the right and left side in order to adjust to asymmetries of neurologic patients.

    The software of the unit allows for adjusting the synchronization between robotic gait orthosis and treadmill.

    The software of the unit allows for adjusting gait velocity specific changes in stride length and stride frequency in order to allow for natural timing of the walking movement.

24.The unit is capable of storing all measured parameters and patient notes during the individual training sessions.   Feedback

    The unit is equipped with a 32’’patient feedback screen for visualization of the patient’s performance.

26.The system allows measuring the gait performance via force sensors.

The unit provides visualization of real-time feedback of the patients’ performance.

The system continuously records the knee and hip joint activity and displays values for the swing and the stance phase of walking, as well as for the right and left leg.

The unit visualizes the gait performance in graphs.

The unit visualizes the gait performance as a smiley that starts smiling as soon as the patient is more active.

31.The unit provides a motivating and instructive functional feedback in virtual environments with an appropriate choice of several different environments (Augmented Performance Feedback).

The unit provides Augmented Performance Feedback exercises to specifically focus on attention and motivation.

The unit provides Augmented Performance Feedback exercises to specifically focus on endurance.

The unit provides Augmented Performance Feedback exercises to specifically focus on activity timing.

The unit provides Augmented Performance Feedback exercises to specifically focus on movement pattern.

   The unit provides Augmented Performance Feedback exercises to specifically focus on gait symmetry.

    The unit provides enhanced assist-as-needed support with the new Path Control feature that enables free timing of movements while still ensuring a physiologic gait pattern.

    The unit provides the “Speed-up” feature that rewards patient activity with higher walking speeds.

39.The unit provides the “Gait Variation” feature that introduces small variations to the gait pattern even for patient who require maximal Guidance Force.

40.The settings of the unit’s Augmented Performance Feedback are adjustable via the user software.

41.The unit measures the patient’s movement through the measurement units of the robot.

Difficulty levels and exercise duration of the unit are adjustable to patients cognitive, gait phase dependent and side specific abilities.

43.The unit’s Augmented Performance Feedback is available with software for Adult use.

44.The unit’s Augmented Performance Feedback is available with software explicitly designed for use in pediatric patients. 45.Evidence gathered from trials with the unit suggests that the Augmented Performance Feedback reality scenarios are as effective as positive feedback by the therapist and lead to significantly higher muscle activation and effort during walking.   Active training

The system should include a “guidance force control”.

The “guidance force control” of the unit allows a continuously adjustable level of gait assistance for each leg between full and zero guidance of the legs that encourages the patients to work harder.

The system allows setting the level of guidance individually for the left and right leg of the patient which is required in most neurologic patients.

The system contains pre-programmable training parameters to automatically vary training parameters.

The unit allows speed and unloading training programs.

The unit allows interval or pyramid training.

Assessment Tools

52.The unit offers the assessment of the main problems of neurological patients.

53.The unit assesses stiffness in the patient’s hip and knee joints.

54.The unit assesses isometric force generated by the patient. 55.The unit assesses the patient’s hip and knee- passive range of motion.

56.The unit visualizes assessment results on the patient screen.  

Research Tools

The unit should contain research functionality in order to collect a wide range of training data.

The unit should allow to record data.

59.The unit allows the therapist to choose and create data sets for recording. 60.The recordable data set of the unit should at least consist of 10 signals. 61.The unit should allow to export a wide range of training data for later analysis.   Reporting Tool 62.The unit allows to display and summarize all training data. 63.The unit allows to generate individual therapy reports per patient. 64.The unit allows to display data in single sessions and as therapy progression format.   Connectivity and remote support 65.The unit allows to print reports from the unit into the clinic network. 66.The unit allows remote support access for clinical and technical support and software update.   Safety Mechanisms 67.The unit should provide different and independent safety systems. 68.The unit should be equipped with wireless remote control that must be pressed by the user to confirm that the system is running safely and correctly. 69.The unit has an emergency stop button. 70.The emergency stop should be clearly marked with a red stop button. 71.The system should detect undesired movements and stop automatically if the range of movement is beyond a certain threshold or if a patient is stumbling.

72.The system should contain a torque monitoring system which automatically stops the machine if the torque is beyond the normal range or if a patient generates too high forces, which could be generated through the patient’s spasticity.

73.The body weight support system of the unit should have an emergency release.   Electronics

74.The unit should have 2 independent connections, power supply should be chosen according to country specific requirements with voltage 220-240 VAC and either 50 Hz or 60 Hz frequency or of voltage 110-120 VAC with either 50 Hz or 60 Hz frequency.   Orthopedic material and storage

75.The adult version of the unit should include patients’ harnesses in four different sizes for different sized patients.

76.The unit should include cuffs for the upper, middle and lower legs in seven different sizes to attach the patient’s legs to the orthosis.

77.The unit should include foot lifter sets.

78.The harnesses should be washable at 60°C in the washing machine. 79.The unit should be equipped with different cushioning materials for the back, the gluteus and the shins.

80.The unit should be upgradable with an orthopedic storage trolley or wall mount solution which allows ergonomic handling of the orthopedic material.   Specifications 81.The dimensions of the unit should be 3251 x 1551 x 2458 mm (orthosis pivoted in), 3495 x 2141 x 2458 mm (orthosis pivoted out).

82.The weight of the unit should be 900 - 1100 kg. 83.The unit should fit into a room with height required 240 cm.

84.The unit should be extendable in length for the fit in rooms with 250 cm room height. 85.The unit should allow training of patients with maximum height of 193 cm (for room height 250 cm). 86.The unit should be extendable in length to allow training of patients with maximum height of 200 cm (for room height 260 cm).   Classification 87.The unit should have electromagnetic compatibility Class A device (CISPR 11). 88.The unit should meet the requirements of EN 60601-1-2. 89.The unit should meet the protective class SK 1.

90.The unit should be a class IIa device according to the European medical device directive 93/42/EC.   Training

91.The system price includes 2 clinical training courses of 2 days each (basic and advanced) for up to 6 therapists.

92.The system price includes installation and technical training for technical staff on-site by a service engineer including troubleshooting, maintenance and performance of all calibration and quality assurance procedures.

93.The system includes a user manual in English or country specific language. Warranty 94.The unit will have a warranty period of 12 months. 95.Compatible software updates shall be provided free of charge during the warranty period. After sales support

96.The unit’s manufacturer provides a 24 hour technical support for questions via email and phone (irrespective of contracted service or warranty repair covers, weekend and public holidays).

97.The unit’s manufacturer provides remote technical support.

98.The unit’s manufacturer enables short reaction time in case of breakdown through worldwide service network with technicians intensively trained and certified by the manufacturer.

99.The unit’s manufacturer provides clinical support for questions via email and phone. 100.The manufacturer provides a clinical knowledge platform with latest information about products, state of the art clinical research and the possibility to exchange with other professionals in the community. 101.The manufacturer provides all services according to the product specifications for the whole product lifecycle to ensure technical compliance and safe operation of the product at any time.