Legal Notes

1. Introduction

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 is just as important 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.

 

2. Medical Purpose

The main purpose of the Reha-Stim devices is for the clinical rehabilitation of gait or upper extremities of patients with neurological and / or orthopedic disorders as well as research with patients or healthy individuals.

 

2.1 The FLOAT

The potential patient groups that can be treated with the FLOAT are, for example:

  • Neurological patients with gait disturbance
  • Spinal cord injury
  • Traumatic brain injury
  • Multiple sclerosis
  • Parkinson
  • Stroke
  • Guillain-Barré syndrome
  • Vestibular patients
  • Orthopedic surgery
  • other diseases which show an impairment of the musculoskeletal system

Patient contraindications include:

  • Cognitive impairment
  • Shortened muscles (extension or upright position not possible)
  • Patients with acute fractures or wounds
  • Brittle bone disease and brittle bones, respectively
  • Epileptic patients
  • Patients with decubiti, which could get in contact with the harness or parts of the harness
  • Known pregnancy

Patients with the above contraindications should be excluded from FLOAT training. Check specifications in the FLOAT datasheet to confirm patient are within size and weight limitations.

 

2.2 Gait Trainer GTII

It is strictly necessary that the patient meets all inclusion criteria. Locomotion therapy on the gait trainer GT II must not be carried out if not all applicable criteria are fulfilled. 

  • Head and trunk control: the patient should be able to sit at the edge of the bed for at least one minute without help or be already mobilized in the wheelchair. 
  • Cardiovascular system: the patient should be able to stand in an upright position in a standing table for 10 minutes without feeling any pain or drop in systolic blood pressure below 90mm/Hg, without dizziness, tachycardia, breathlessness or shortness of breath. 
  • Stabilized lesions of the lower limb or spinal column 
  • The patient must wear robust footwear 
  • Have adequate thrombosis prophylaxis under medical supervision if necessary 
  • Patient height 110cm – 200cm 
  • Patient weight under 200kg 

Patient contraindications include:

It is strictly mandatory that the attending physician and therapist/user review all exclusion criteria. Therapy on the gait trainer GT II is strictly prohibited if one or more exclusion criteria are fulfilled: 

  • Orthostatic circulation problems 

Unstable fractures: Do not train patients with unstable or insufficiently consolidated fractures. 

  • Severe osteoporosis: There is a risk of fractures. 
  • Skin problems: Before and after each therapy, a visual check should be made for existing wounds or pressure points and those that may have been caused by the therapy. 
  • Joint problems: The strain on the joints during gait training can cause pain and irritation in states of reduced resilience. 
  • Strong asymmetries: If the patient has large differences in leg lengths, no training can be performed in the GT II unless he is wearing orthopaedic compensating footwear. 
  • Cooperation: Whether training in GT II can be conducted with patients with reduced cooperation, psychotic diseases or neurotic disorders must be carefully weighed in each case. 
  • Body weight more than 200kg: Training with patients who have a higher body weight is not permitted for safety reasons. 
  • Adjustment: If GT II cannot be optimally adapted to a patient, the training must not be carried out. 
  • Pregnancy: Pregnant women must not be treated with GT II for safety reasons.