Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy
Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy
The GangTrainer GT I and the Lokomat have proven their effectiveness on stroke Patients, but
 a comparison on the same controlled study population has not been made so far. Aim of the
 study will not only be to establish which device will work better on acute, non ambulatory
 stroke Patients in terms of regain of gait ability and motor function, but also clinical
 matters, like the efficacy of the treatment period. As a result of the trial it should be
 highlighted which kind of therapy has to be suggested for Patients comparable to the study
 population. A significant better outcome of one device in regard to the other will suggest to
 use one device more than the other for future treatments.
A total of 120 Patients will be enroled in the study and divided into 2 treatment and 1
 control group. Enroled Patients will all be first supratentorial non ambulatory stroke
 patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12
 weeks.

 Theywill undergo either robotic treatment with the Gangtrainer GT1 or the Lokomat in one of
 the 2 treatment groups for 30 minutes of gross therapy time every workday for a 8 weeks
 period if they are in the treatment group, or conventional physiokinetherapy for 30 minutes
 of gross therapy time every workday for a 8 weeks period if they are in the control group.

 Primary outcome will be the Functional Ambulation Category (FAC) assessed at enrolment, after
 4 weeks after 8 weeks and at 6 months follow up.
Inclusion Criteria:

 -  First supratentorial stroke (ischaemic, haemorrhagic or ICH) resulting in a
 hemiparesis

 -  Interval from stroke 3 - 12 weeks

 -  Non ambulatory (FAC < 3)

 -  Free sitting on bedside for 1 minute, both feet on the floor, ev. holding on bedside
 by hands

 -  Barthel Index 25 - 65

 Exclusion Criteria:

 -  Unstable cardiovascular system (in case of doubt, only after approval by a internist)

 -  Manifested heart diseases like labile compensated cardiac insufficiency (NYHA III),
 angina pectoris, myocardial infarction 120 days before study onset, cardiomyopathy,
 severe cardiac arrhythmia

 -  Severe joint misalignment (severe constriction of movement for hip, knee and/or ankle:
 more than 20° fixed hip and knee extension deficit, or more than 20° fixed plantar
 flexion of the ankle

 -  Severe cognitive dysfunction, which does not allow for comprehension of the aims of
 this study

 -  Severe neurological or orthopaedic diseases (like polio, Parkinson´s disease), which
 massively affect the mobility

 -  Deep vein thrombosis

 -  Severe osteoporosis

 -  Malignant tumour diseases