Clinical trial NCT01146587: Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy
Official title: Robot Assisted Therapy for Acute Stroke Patients: a Comparative Study of GangTrainer GT I, Lokomat System and Conventional Physiotherapy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stroke, Acute
Keywords: Stroke
Robotics
Gait
Rehabilitation
Lead sponsor: Research Department for Neurorehabilitation South Tyrol
Sponsor class: OTHER
Collaborators: name: Privatklinik Villa Melitta
name: Hochzirl Hospital
name: Krankenhaus Bozen
name: Krankenhaus Brixen
name: Krankenhaus Meran
name: Krankenhaus Bruneck
name: Claudiana Landesfachhochschule
First posted: 2010-06-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Ambulation Category (FAC)
timeFrame: after 8 weeks
Secondary outcomes:
measure: Barthel Index (BI)
timeFrame: at week 1
measure: Barthel Index (BI)
timeFrame: after 4 weeks
measure: Barthel Index (BI)
timeFrame: after 8 weeks
measure: Barthel Index (BI)
timeFrame: after 24 weeks
measure: Rivermead Mobility Index (RMI)
timeFrame: at week 1
measure: Rivermead Mobility Index (RMI)
timeFrame: after 4 weeks
measure: Rivermead Mobility Index (RMI)
timeFrame: after 8 weeks
measure: Rivermead Mobility Index (RMI)
timeFrame: after 24 weeks
measure: 10 metres Walking Test
timeFrame: at week 1
measure: 10 metres Walking Test
timeFrame: after 4 weeks
measure: 10 metres Walking Test
timeFrame: after 8 weeks
measure: 10 metres Walking Test
timeFrame: after 24 weeks
measure: 6 Minutes Walking Test on the Floor
timeFrame: at week 1
measure: 6 Minutes Walking Test on the Floor
timeFrame: after 4 weeks
measure: 6 Minutes Walking Test on the Floor
timeFrame: after 8 weeks
measure: 6 Minutes Walking Test on the Floor
timeFrame: after 24 weeks
measure: 6 Minutes Walking Test on the Treadmill with Body Weight Support
timeFrame: at week 1
measure: 6 Minutes Walking Test on the Treadmill with Body Weight Support
timeFrame: after 4 weeks
measure: 6 Minutes Walking Test on the Treadmill with Body Weight Support
timeFrame: after 8 weeks
measure: 6 Minutes Walking Test on the Treadmill with Body Weight Support
timeFrame: after 24 weeks
measure: Medical Research Council (MRC)
timeFrame: at week 1
measure: Medical Research Council (MRC)
timeFrame: after 4 weeks
measure: Medical Research Council (MRC)
timeFrame: after 8 weeks
measure: Medical Research Council (MRC)
timeFrame: after 24 weeks
measure: Modified Ashworth Scale (mAS)
timeFrame: at week 1
measure: Modified Ashworth Scale (mAS)
timeFrame: after 4 weeks
measure: Modified Ashworth Scale (mAS)
timeFrame: after 8 weeks
measure: Modified Ashworth Scale (mAS)
timeFrame: after 24 weeks
measure: Rivermead Visual Gait Assessment (RVGA)
timeFrame: at week 1
measure: Rivermead Visual Gait Assessment (RVGA)
timeFrame: after 8 weeks
measure: Rivermead Visual Gait Assessment (RVGA)
timeFrame: after 24 weeks
measure: EuroQol 5 Dimensions (EQ-5D)
timeFrame: at week 1
measure: EuroQol 5 Dimensions (EQ-5D)
timeFrame: after 8 weeks
measure: EuroQol 5 Dimensions (EQ-5D)
timeFrame: after 24 weeks
measure: modified emory Functional Ambulation Profile (meFAP)
timeFrame: at week 1
measure: modified emory Functional Ambulation Profile (meFAP)
timeFrame: after 4 weeks
measure: modified emory Functional Ambulation Profile (meFAP)
timeFrame: after 8 weeks
measure: modified emory Functional Ambulation Profile (meFAP)
timeFrame: after 24 weeks
measure: Functional Ambulation Category (FAC)
timeFrame: at week 1
measure: Functional Ambulation Category (FAC)
timeFrame: after 4 weeks
measure: Functional Ambulation Category (FAC)
timeFrame: after 24 weeks
Other outcomes:
Locations:
city: Hochzirl
country: Austria
facility: Hochzirl Hospital
state: Tirol
city: Bozen
country: Italy
facility: Claudiana Landesfachhochschule
state: Südtirol
city: Bozen
country: Italy
facility: Krankenhaus Bozen
state: Südtirol
city: Bozen
country: Italy
facility: Privatklinik Villa Melitta
state: Südtirol
city: Brixen
country: Italy
facility: Krankenhaus Brixen
state: Südtirol
city: Bruneck
country: Italy
facility: Krankenhaus Bruneck
state: Südtirol
city: Meran
country: Italy
facility: Krankenhaus Meran
state: Südtirol
Study officials:
affiliation: Privatklinik Villa Melitta
name: Andreas Waldner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Privatklinik Villa Melitta
name: Christopher Tomelleri, MSc
role: STUDY_CHAIR
affiliation: Hochzirl Hospital
name: Leopold Saltuari, MD PhD
role: STUDY_DIRECTOR
References:
citation: Kolominsky-Rabas PL, Heuschmann PU. [Incidence, etiology and long-term prognosis of stroke]. Fortschr Neurol Psychiatr. 2002 Dec;70(12):657-62. doi: 10.1055/s-2002-35857. German.
citation: Barbeau H, Visintin M. Optimal outcomes obtained with body-weight support combined with treadmill training in stroke subjects. Arch Phys Med Rehabil. 2003 Oct;84(10):1458-65. doi: 10.1016/s0003-9993(03)00361-7.
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citation: Baer HR, Wolf SL. Modified emory functional ambulation profile: an outcome measure for the rehabilitation of poststroke gait dysfunction. Stroke. 2001 Apr;32(4):973-9. doi: 10.1161/01.str.32.4.973.
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citation: Lord SE, Halligan PW, Wade DT. Visual gait analysis: the development of a clinical assessment and scale. Clin Rehabil. 1998 Apr;12(2):107-19. doi: 10.1191/026921598666182531.