Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Robot Assisted Therapy for Acute Stroke Patients: a Comparative Study of GangTrainer GT I, Lokomat System and Conventional Physiotherapy

Conditions
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Stroke, Acute

Intervention / Treatment
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* Device: GangTrainer GT1
* Device: Lokomat
* Other: Conventional Physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GangTrainer GT1<br>First supratentorial non ambulatory stroke patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12 weeks undergo robotic treatment with the Gangtrainer GT1 for 30 minutes of gross therapy time every workday for a 8 weeks period | Device: GangTrainer GT1<br>* 30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks<br>* Other names: Group A;|
| Experimental: Lokomat<br>First supratentorial non ambulatory stroke patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12 weeks undergo robotic treatment with the Lokomat for 30 minutes of gross therapy time every workday for a 8 weeks period | Device: Lokomat<br>* 30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks<br>* Other names: Group B;|
| Active Comparator: Conventional Physiotherapy<br>First supratentorial non ambulatory stroke patients (ischaemic, haemorrhagic or ICH) with a hemiparesis and stroke onset from 3 - 12 weeks undergo a conventional physiokinetherapeutic treatment session for 30 minutes of gross therapy time every workday for a 8 weeks period | Other: Conventional Physiotherapy<br>* 60 minutes of Conventional Physiotherapy every workday for 8 weeks<br>* Other names: Group C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulation Category (FAC) |  | after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel Index (BI) |  | at week 1 | 
| Barthel Index (BI) |  | after 4 weeks | 
| Barthel Index (BI) |  | after 8 weeks | 
| Barthel Index (BI) |  | after 24 weeks | 
| Rivermead Mobility Index (RMI) |  | at week 1 | 
| Rivermead Mobility Index (RMI) |  | after 4 weeks | 
| Rivermead Mobility Index (RMI) |  | after 8 weeks | 
| Rivermead Mobility Index (RMI) |  | after 24 weeks | 
| 10 metres Walking Test |  | at week 1 | 
| 10 metres Walking Test |  | after 4 weeks | 
| 10 metres Walking Test |  | after 8 weeks | 
| 10 metres Walking Test |  | after 24 weeks | 
| 6 Minutes Walking Test on the Floor |  | at week 1 | 
| 6 Minutes Walking Test on the Floor |  | after 4 weeks | 
| 6 Minutes Walking Test on the Floor |  | after 8 weeks | 
| 6 Minutes Walking Test on the Floor |  | after 24 weeks | 
| 6 Minutes Walking Test on the Treadmill with Body Weight Support |  | at week 1 | 
| 6 Minutes Walking Test on the Treadmill with Body Weight Support |  | after 4 weeks | 
| 6 Minutes Walking Test on the Treadmill with Body Weight Support |  | after 8 weeks | 
| 6 Minutes Walking Test on the Treadmill with Body Weight Support |  | after 24 weeks | 
| Medical Research Council (MRC) |  | at week 1 | 
| Medical Research Council (MRC) |  | after 4 weeks | 
| Medical Research Council (MRC) |  | after 8 weeks | 
| Medical Research Council (MRC) |  | after 24 weeks | 
| Modified Ashworth Scale (mAS) |  | at week 1 | 
| Modified Ashworth Scale (mAS) |  | after 4 weeks | 
| Modified Ashworth Scale (mAS) |  | after 8 weeks | 
| Modified Ashworth Scale (mAS) |  | after 24 weeks | 
| Rivermead Visual Gait Assessment (RVGA) |  | at week 1 | 
| Rivermead Visual Gait Assessment (RVGA) |  | after 8 weeks | 
| Rivermead Visual Gait Assessment (RVGA) |  | after 24 weeks | 
| EuroQol 5 Dimensions (EQ-5D) |  | at week 1 | 
| EuroQol 5 Dimensions (EQ-5D) |  | after 8 weeks | 
| EuroQol 5 Dimensions (EQ-5D) |  | after 24 weeks | 
| modified emory Functional Ambulation Profile (meFAP) |  | at week 1 | 
| modified emory Functional Ambulation Profile (meFAP) |  | after 4 weeks | 
| modified emory Functional Ambulation Profile (meFAP) |  | after 8 weeks | 
| modified emory Functional Ambulation Profile (meFAP) |  | after 24 weeks | 
| Functional Ambulation Category (FAC) |  | at week 1 | 
| Functional Ambulation Category (FAC) |  | after 4 weeks | 
| Functional Ambulation Category (FAC) |  | after 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Robotics, Gait, Rehabilitation