The physician in charge has the sole medical responsibility for a rehabilitation treatment and decides whether a patient is fit for a specific treatment. In particular, the physician must weigh in each individual case possible risks and side-effects of the treatment against the expected benefit. In addition, the patient’s individual situation plays just as important a role as the basic risk assessment for specific patient groups. The person in charge of using the system is responsible to adapt the training sessions and the course of therapy to the patient’s abilities.

Being a scientific discipline, medicine is subject to constant advances of knowledge and treatment principles. The physician in charge must continually keep his knowledge up-to-date by reading the latest scientific literature and must monitor changes in use recommendations during the course of treatment.

All Hocoma products are medical devices and must be used in strict adherence to the User Manual; failure to do so may result in serious personal injury. It is strongly recommended that you regularly consult Hocoma’s website (www.hocoma.com/legalnotes) for the latest available information. Please contact Hocoma should you have any questions.

Use only under the supervision of qualified medical personnel. However, certain Hocoma products are marketed for home use and must be strictly used according to the recommendations of your medical care provider who is knowledgeable about your specific needs. Consult the User Manual and Hocoma’s website (www.hocoma.com/legalnotes) for appropriate product designation. Failure to obtain and follow the recommendations of your medical care provider may result in serious personal injury.

This information provides details about medical products which may not be available in all countries and may not have received approval or market clearance by all governmental regulatory bodies throughout the world. Nothing herein should be construed as a solicitation or promotion of any product or of an indication of any specific use for any product which is not authorised by the laws and regulations of the country where the reader of this information resides.

For more detailed information about the application of our devices please refer to these sections:

Lokomat, Pediatric Lokomat, Andago
ArmeoSpring, ArmeoBoom
ArmeoPower
Erigo
ValedoMotion
ValedoShape

Lokomat, Andago

Purpose and contraindications
The purpose in using the Lokomat is to support treadmill training being used to treat patients with walking disabilities caused by cerebral, neurogenic, spinal, muscular or bone related disorders.
Taking into account the contraindications and every patient’s individual profile, the device is used in the case of:

• Stroke
  
• Multiple sclerosis
  
• Cerebral palsy
• Parkinson’s disease
• Paraplegia
• Traumatic brain injury
• after endoprosthesis surgery (e.g. total hip endoprostheses)
• Degenerative joint diseases of the lower limbs (e.g. osteoarthritis of the knee)
• Spinal muscular atrophy
  
• Muscle weakness due to lack of mobility
  
• Hemiplegic patients
  
• Paraplegic patients

Just as for any other therapy, the physician in charge is always responsible for indicating treadmill training. The same indications and contraindications basically apply for training on the Lokomat as for manual treadmill training with body weight support. The following contraindications must be observed in particular:

• Orthosis not adaptable to the patient’s body (lower limbs)
• Body weight of more than 135 kg
• Severely fixed contractures
  
• Bone instability (non-consolidated fractures, unstable spinal column and severe osteoporosis)
• Open skin lesions in the area of the lower limbs and/or torso
• Circulatory problems
• Cardiac contraindications
• Uncooperative or (self-) aggressive behaviour, such as transitory psychotic syndrome
• Severe cognitive deficits
• Patients with (long-term) infusions
• Mechanical ventilation
• Patients with extremely disproportionate growth of the legs and/or spinal column (e.g. bone or cartilage dysplasia)
• Severe vascular disorders of the lower limbs
• In general, patients who have been ordered to remain in bed or immobile due to, for instance, osteomyelitis or other inflammatory/infectious disorders
• Hip, knee, ankle arthrodesis

The above list does not claim to be exhaustive.

In the case of chronic patients and/or patients who have been immobile for a long period of time, short training sessions are recommended to begin with, using a high level of body weight support. An over-reaction is expected from these patients if training sessions are too long. Increased osteoporosis formation must be taken into account with chronic patients. On the other hand, patients often tend to have a certain euphoric reaction after the initial treatment, and want to have longer and/or more frequent training sessions. This can result, in the case of the patients described above, in excessive strain being exerted on ligaments, tendons, joints and bones, which can lead in turn to hyperextension, tears and even spontaneous fractures.

ArmeoSpring, ArmeoBoom

Arm therapies are used as part of the rehabilitation of patients with a diminished function of the upper extremities.

The ArmeoSpring’s and the ArmeoBooms’s purpose is to support functional therapy for patients who have lost the function of or have restricted function in their upper extremities caused by cerebral, neurogenic, spinal, muscular or bone-related disorders. Taking into account the contraindications and every patient’s individual profile, the device is used in the case of:
Strokes

• Multiple sclerosis
• Cerebral palsy
• Follow-up care after brain-tumor operations
• Spinal cord injuries
• Traumatic brain injury
• Endoprostheses; follow-up care for elbow and shoulder endoprostheses
• Muscular atrophy
• Muscle weakness due to lack of mobility
• Hemiplegic patients

Just as for any other therapy, the physician in charge is always responsible for the indication. Functional training with the ArmeoSpring and ArmeoBoom is not possible or indicated in every case. In general, the device must not be used in the following cases to avoid causing harm to the patient. The following contraindications must therefore be observed in particular:

• Orthosis cannot be fitted to the relevant arm - upper arm length: 220-310 mm, forearm length from elbow to grip axis: 292-394 mm (not applicable for ArmeoBoom)
• Bone instability (non-consolidated fractures, severe osteoporosis),
• Pronounced, fixed contractures affecting the relevant extremity
• Open skin lesions in the area of the relevant upper extremity
• Paraesthesia
• Shoulder joint subluxation or pain in the shoulder joint
• Severe spasticity
• Severe spontaneous movements, e.g. ataxia, dyskinesia, myoclonic jerks
• Non-stable vital functions: Pulmonary or cardio-circulatory contraindications (instability or instrumental support for these functions)
• Need for long-term infusion therapy
• Severe postural instability
• Contraindicated sitting position
• Confused or non-cooperative patients
• Severe cognitive deficits
• Patients requiring isolation due to infections
• Severe visual problems (patient is not able to see displayed elements on the computer screen)

The above list does not claim to be exhaustive.

In the case of chronic patients and/or patients who have been immobile for a long period of time, short training sessions are recommended to begin with.. An over-reaction is expected from these patients if training sessions are too long. Increased shoulder subluxation and osteoporosis formation must be taken into account with chronic patients. On the other hand, patients often tend to have a certain euphoric reaction after the initial treatment, and want to have longer and/or more frequent training sessions. This can result, in the case of the patients described above, in excessive strain being exerted on ligaments, tendons and joints.

The decision as to whether a patient is suitable for treatment always comes under the remit of the physician in charge, who has sole medical responsibility for the treatment. As part of this, he must evaluate in particular, in each individual case, possible risks and side-effects of the treatment against the benefit gained from it. In addition, the patient’s individual situation plays just as important a role as the basic risk assessment for specific patient groups.

ArmeoPower

Contraindications
Just as for any other therapy, the physician in charge is always responsible for the indication. Functional therapy with the ArmeoPower is not possible or indicated in every case. In general, the ArmeoPower must not be used in the following cases to avoid causing harm to the patient. The following contraindications must therefore be observed in particular:
• Orthosis cannot be fitted to the relevant arm
• Bone instability in relevant areas of the upper extremity (non-consolidated fractures, frail fractures due to osteoporosis)
• Fixed contractures affecting the relevant extremity (e.g. frozen shoulder)
• Shoulder instability with uncontrolled shoulder displacement during the ArmeoPower training
• Severe pain syndromes caused or intensified by the ArmeoPower training
• Instable vital functions (pulmonary or cardio-circulatory)
• Medical contraindication to bring the patient into a sitting position
• Patients requiring isolation due to infections
• Epileptic disorder with frequent seizures bearing the risk of experiencing a seizure during the ArmeoPower training

The above list does not claim to be exhaustive. The decision as to whether a patient is suitable for therapy always comes under the remit of the physician in charge, who has sole medical responsibility for the therapy. As part of this, he must evaluate in particular, in each individual case, possible risks and side-effects of the therapy against the benefit possibly gained from it. Here, the patient’s individual situation plays just as an important role as the basic risk assessment for specific patient groups.

It is the duty of the person in charge of using the system to adapt the therapy sessions and course of therapy to the patient’s abilities and best possible outcome.

Because of new discoveries and advances, medicine as a scientific discipline is subject to constant change. It is the responsibility of the responsible physician to constantly update the state of his knowledge by means of current scientific specialist literature, and to acquire new knowledge regarding therapy advances. In case anything is unclear or you have feedback, please contact Hocoma (www.hocoma.com).

Risk Factors
In addition to the above list of contraindications, there are several risk factors, which do not have to exclude a patient from training with the ArmeoPower, but require a thorough evaluation of possible risks and adverse effects of the therapy against the potential benefits. When the physician in charge decides to apply ArmeoPower training despite the presence of any of the risk factors listed below or additional risk factors he or she is aware of, the person in charge of using the system has to be notified about these risk factors and needs to remain specifically attentive to any potential dangers for the patient. The ArmeoPower training has to be immediately terminated as a consequence of any potentially dangerous situation arising from any of the following risk factors:

• Orthopedic or rheumatologic disease, severely affecting the relevant extremity
• Open skin lesions or skin disease in relevant areas of the upper extremity
• Osteoporosis
• Shoulder joint subluxation
• Spasticity
• Epileptic disorder
• Anesthesia or analgesia preventing sensory feedback regarding the cuff fixations or for controlling the range of motion in the relevant upper extremity
• Need for (long-term) infusion therapy
• Risk of spontaneous movements, e.g. due to myoclonus, dystonia, dyskinesia, hemiballismus
• Postural instability
• Visual problems (patient is not able to see displayed elements on the computer screen)
• Cybersickness
• Neglect syndrome
• Cognitive deficits
• Confusion, somnolence, uncooperative or (self-)aggressive behavior

Erigo

The Erigo supports and facilitates the mobilization of patients carried out by physicians and physical therapist. Even bed-ridden patients can be verticalized, mobilized and load can be applied on the lower legs.

The purpose of the Erigo is summarized as follows:

1. to support mobilization in bedridden patients
2. prophylaxis for secondary damage resulting from patients being bed-ridden
3. to improve the degree of alertness in patients with brain injuries by providing sensory experiences

Bearing in mind the contraindications and the individual characteristics of each patient, the Erigo is used for:

• instable circulation (hypotension)
• spasticity of the lower extremities
• mobilizing patients with serious brain damage
• impaired lung function

It is not always appropriate to treat patients by means of mobilisation, weight bearing on the lower extremities and placing them in a vertical position. Furthermore, the equipment has not been designed for all heights and weights. For this reason, the Erigo must not be used in cases of:

• Severe fixed contractures of the lower extremities (hips, knees, foot joints)
• Body weight of more than 135 kg
• Patient height above 210 cm
• Inability to adjust the equipment settings to suit the patient adequately.
• Osseous instability (non-consolidated fractures, unstable vertebral column, severe osteoporosis, pseudoarthosis)
• Open skin lesions on the lower extremities and/or on the back [positioning]
• Cardiac contraindications
• Uncooperative or (auto)aggressive behaviour such as symptomatic transitory psychosis
• Patients with severely disproportionate growth of the legs and or the vertebral column
  (e.g. bone or cartilage dysplasia)
• Vessel disease of the lower extremities
• Patients who have been prescribed bed rest or immobilisation, e.g. with osteomyelitis or other inflammatory/infectious diseases

This list does not claim to be exhaustive.

ValedoMotion

1. Indications
The ValedoMotion can be beneficial for the following patient groups:

• Non specific low back pain, and those diagnosed with “Lumbago”*
• Problems with the sacroiliac joint
• Stability training
• Mobility training
• Improved balance training
• Stroke patients with little or no Apraxia.

*Lumbago is primarily associated with non-specific low back pain, often caused by muscular deficits.

The ValedoMotion can be beneficial for the following patient groups, but only in consultation with their physiotherapist / doctor:

• Hernia, including post operative (including spinal or abdominal)
• Ankylosing spondylitis (old name: Morbus Bechterew)
• Osteoporosis (light or mild)
• MS patients (non progressive stage)
• Parkinson’s patients
• Younger aged stenosis patients.

2. Contraindications
The following contraindications are mandatory:

• Bone cancer, including spinal tumors or metases to vertebrae or joints
• Vertebral fractures
• Acute inflammation of bones or joints (e.g. rheumatoid arthritis etc)
• Acute lumbar nerve root entrapments leading to nerve root inflammation signs and / or nerve root conduction loss
• Infection of bones or joints
• Severe osteoporosis or bone loss (e.g. osteomalacie)
• Spondylolisthesis (second degree or higher) or with neurological signs.
• Implanted ferromagnetic materials or active devices within the body.
• Skin disease or lesion in the vicinity of sensor placement, including broken skin, eczema etc.
• Patients who have been subjected to long term bed rest.

3. Risk Factors

• Recent serious accidents (e.g. whiplash) without prior consultation with a doctor
• Chondromalacie at facette level
• Acute hernia (including spinal or abdominal)
• Severe cardiovascular disease (e.g. aortic aneurysm, intra-articular haemorrhage)
• Neurological disability, including compression of the spinal cord or cauda equine, nerve root compression etc.
• Severe balance deficits
• Cognitive deficits which prevent comprehension of exercises
• Pregnancy
• Epileptic seizure within the past past 2 years which are not controlled medically, or patients are photosensitive.
• Retinal disease which may be exasperated by watching video games.
• Spondylodesis in the sacral region

Do not train patients in a standing position if they have a sever balance deficit (e.g. a Berg Balance Scale < 45). If patients suffer from reddening, irritated or itching of skin or erythroderma then prescribing clinician must monitor the area under the sensors. If reddening, irritation or itching lasts longer than 24 hours the patient should seek medical advice. If the patient is not able to normally participate in video games they should not use the Valedo device.

The above list does not claim to be exhaustive. The decision as to whether a patient is suitable for treatment always comes under the remit of the physician in charge, who has sole medical responsibility for the treatment. As part of this, he must evaluate in particular, in each individual case, the possible risks and side-effects of the treatment against the benefit gained from it. In addition, the patient’s individual situation plays just as important a role as the basic risk assessment for specific patient groups.

The ValedoShape should not be used for patients for whom one or more of the following conditions apply:

• Open wounds, or major injuries to the spine from C7 to S3.
• Irritated, inflamed or infected skin or tissue wounds from C7 to S3

Before using ValedoShape, clarify whether the patient may, for health reasons, carry out a flexion–extension movement to the maximum angle for approximately one minute. If pain is experienced then the patient must not be allowed to bend further forwards or backwards.

Before determining the postural competence (analogous to the Matthiass test), clarify whether the patient may, for health reasons:

• Maintain and hold the posture for at least a minute. If pain occurs the test must stop.
• Can lift and hold the additional weights for a minute. If pain occurs the weight must be reduced or omitted, or the test must stop.

The list is not exhaustive. The decision as to whether a patient is suitable for treatment is at the discretion of the treating physician.