Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy "galop"

Suspended

Phase N/A Results N/A

Trial Description

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.

Trial Stopped: GangTrainer GT1 is not state of the art anymore for the principal Invesigator

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors