Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy (galop)

Research Department for Neurorehabilitation South Tyrol

Status: Suspended

Conditions: Stroke, Acute

Treatments: Device: Lokomat; Other: Conventional Physiotherapy; Device: GangTrainer GT1

Study type: Interventional

Funder types: Other

Identifiers

NCT01146587

GT-LK-PT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

GangTrainer GT1

Experimental group

Description:

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

Treatment:

Device: GangTrainer GT1

Lokomat

Experimental group

Description:

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

Treatment:

Device: Lokomat

Conventional Physiotherapy

Active Comparator group

Description:

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

Treatment:

Other: Conventional Physiotherapy