The Lokomat is intended for the rehabilitative treatment of patients with severe to moderate impairments in walking abilities and functional mobility. These impairments in body functions and activities can be caused by different diseases, including, but not limited to, neurological diseases, such as acquired brain injury (through stroke or trauma), spinal cord injury and cerebral palsy.
Lokomat training may not be conducted if one of the following conditions is present:
- Considerably reduced bone density (osteopenia or osteoporosis). Hereby, due to the forces exerted on the lower extremities, no Lokomat training may be conducted in patients where considerable bone density loss and an increased risk of fractures can be suspected from their history (for example in individuals who had prolonged reduced weight bearing), or in patients where considerable bone density loss has even been diagnosed.
- Training is contraindicated if the person weights more than 135 kg (297 lb.) or is taller than 2 m (78.7 in.) or than 1.95 m (76.7 in) (depending on the version). The Lokomat devices are tested for persons up to 135 kg and 2 m body height. Persons taller or weighing more than this may not be trained in the devices for safety reasons.
- Lokomat training is contraindicated if the person weighs less than 10 kg (22 lb.)
- Non-consolidated fractures
- Any medical condition preventing active rehabilitation (e.g., respiratory disease, pregnancy, orthopaedic conditions, cognitive deficits limiting communication, neuropsychological conditions, infections or inflammatory disorders, osteomyelitis…)
- Fixed joint contractures that limit the range of motion of the orthosis
- A proper fit of the harness and the orthoses is crucial. Lokomat training is therefore contraindicated in patients with an upper leg length of less than 21 cm (8.3 in.) or more than 35 cm (13.8 in.) (paediatric orthosis) or less than 35 cm (13.8 in.) and more than 47 cm (18.5 in.) (adult orthosis). Lokomat training is furthermore contraindicated in case of the inability to properly adjust the harness and/or orthoses to the respective body part due to:
- colostomy bags
- uncorrectable differences in leg length
- skin lesions that cannot be protected appropriately
- any other reason that prevents a proper, pain-free adjustment of the harness and/or orthoses.
In addition to the above list of contraindications, there are several risk factors, which do not have to exclude a patient from training but require increased attention of the person in charge of using the system with respect to the applicable risk factors.
Each one of these conditions can be a risk factor if present to a low to moderate degree and as a single factor, but can also become a contraindication if present to a more marked degree and/or if several conditions are present simultaneously.
If any or several of these conditions are present, additional safety measures are required, for example regular monitoring of vital signs during training or the use of a brace or an insole. The more risk factors present and/or the more serious they are in an individual patient, the more likely it becomes that the use of the devices is contraindicated.
Lokomat training should be immediately terminated as a consequence of any potentially dangerous situation arising from the below listed risk factors.
- Arthroplasty (especially hip arthroplasty or arthroplasties where external hip rotation is contraindicated for the patient)
- Uncontrolled hip, knee or ankle instability that would still pose a danger despite the body weight support (especially lateral instability when training with the FreeD module).
- Lack of head control
- Joint contractures or limitations in the range of motion due to spasticity that can’t be reduced
- Differences in leg length correctable with an insole
- Sensory impairment in the lower limbs and trunk, especially reduced pain sensation
- Risk of autonomic dysreflexia (level at or above T6; history of AD increases the risk of having a reoccurring episode)
- Recent history or elevated risk of seizures
- Cardiac instable conditions, e.g., cardiac insufficiency and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, vascular disorders of the lower limbs
- Uncooperative or (self-)aggressive behavior (e.g., transitory psychotic syndrome)
- Mechanical ventilation
- Long-term infusions (e.g., baclofen pump, intrathecal pumps, PEG tube…) or stimulators (e.g. pacemakers, nerve stimulators)
- Skin lesions (including pressure sores) in areas of contact with harness support, robotic orthosis (buttocks and along lower extremities) or lower extremity loading (feet).
There are populations with sensitive skin and comorbidities that impact the skin. Patients with Spinal Cord Injuries experience decreased sensation because of their injury or medical condition. Impaired sensation can lead to the development of pressure sores because the patient is unaware of any problem. They cannot tell the therapist if something hurts or does not feel right. Older adults have gone through intrinsic changes, among them: reduction of collagen type I, elastin, fibroblasts and sebum secretion. Pediatric patients have thinner skin that is more easily damaged.
- Bariatric patients who have less vascularization of the adipose tissue and are associated with other comorbidities.
- HIV and AIDS patients who are immuno-suppressed.
- Comorbidities that impact the skin:
- Diabetes with microvascular and neurologic changes (prolonged wound healing)
- Altered nutritional status
- Altered hormone levels (estrogen, testosterone, GH)
- Atherosclerosis, decreased perfusion
- Venous insufficiency
- Any source of edema: lymphedema, venous stasis, hypoalbuminemia
- Colonization of skin with fungus and pathogenic, multiple resistant bacteria
- Pharmacologically compromised: corticosteroids, immunomodulators
These lists do not claim to be exhaustive. The clinician in charge has the sole medical responsibility for the rehabilitation treatment and for deciding whether a patient is fit for a specific treatment. In particular, the clinician must weigh in each individual case the possible risks and side effects against the expected benefits. In addition, the patient’s individual situation plays just as important a role as the basic risk assessment for specific patient groups. The treating clinician is responsible for adapting the training sessions and the course of therapy to the patient’s abilities.
Due to the constant advances in medical knowledge and treatment, the clinician in charge must continually keep up-to-date by reading the latest scientific literature and being informed of changes in treatment recommendations. In the case of chronic patients 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 overreaction can be expected from these patients if the training sessions are too long. Increased development of osteoporosis in chronic patients has to be taken into account. On the other hand, some patients may have a certain euphoric reaction after the first treatment sessions and want to have longer 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 to hyperextension, tears and even spontaneous fractures.
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