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.
Trial Stopped: GangTrainer GT1 is not state of the art anymore for the principal Invesigator
- Lokomat Device
Intervention Desc: 30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks ARM 1: Kind: Experimental Label: Lokomat
- Conventional physiotherapy Behavioral
Intervention Desc: 60 minutes of Conventional Physiotherapy every workday for 8 weeks ARM 1: Kind: Experimental Label: Conventional Physiotherapy
- GangTrainer GT1 Device
Other Names: Group A Intervention Desc: 30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks ARM 1: Kind: Experimental Label: GangTrainer GT1
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Functional Ambulation Category (FAC)||at week 1||No|
|Primary||modified emory Functional Ambulation Profile (meFAP)||at week 1||No|
|Secondary||Barthel Index (BI)||at week 1||No|
|Secondary||Rivermead Mobility Index (RMI)||at week 1||No|
|Secondary||10 metres Walking Test||at week 1||No|
|Secondary||6 Minutes Walking Test on the Floor||at week 1||No|
|Secondary||6 Minutes Walking Test on the Treadmill with Body Weight Support||at week 1||No|
|Secondary||Medical Research Council (MRC)||at week 1||Yes|
|Secondary||Modified Ashworth Scale (mAS)||at week 1||No|
|Secondary||Rivermead Visual Gait Assessment (RVGA)||at week 1||No|
|Secondary||EuroQol 5 Dimensions (EQ-5D)||at week 1||No|