Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy

Stroke, Acute Clinical Trial

— galop  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01146587
• Other study ID #: GT-LK-PT
• Status: Suspended
• Phase: N/A
• First received: June 14, 2010
• Last updated: June 4, 2015
• Start date: August 2010
• Est. completion date: February 2016

Study information

• Verified date: June 2015
• Source: Research Department for Neurorehabilitation South Tyrol
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke, Acute

Intervention

Device:
• GangTrainer GT1
30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
• Lokomat
30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks

Other:
• Conventional Physiotherapy
60 minutes of Conventional Physiotherapy every workday for 8 weeks

Locations

Country	Name	City	State
Austria	Hochzirl Hospital	Hochzirl	Tirol
Italy	Claudiana Landesfachhochschule	Bozen	Südtirol
Italy	Krankenhaus Bozen	Bozen	Südtirol
Italy	Privatklinik Villa Melitta	Bozen	Südtirol
Italy	Krankenhaus Brixen	Brixen	Südtirol
Italy	Krankenhaus Bruneck	Bruneck	Südtirol
Italy	Krankenhaus Meran	Meran	Südtirol

Sponsors (8)

Lead Sponsor	Collaborator
Research Department for Neurorehabilitation South Tyrol	Claudiana Landesfachhochschule, Hochzirl Hospital, Krankenhaus Bozen, Krankenhaus Brixen, Krankenhaus Bruneck, Krankenhaus Meran, Privatklinik Villa Melitta

Countries where clinical trial is conducted

Austria,  Italy, 

References & Publications (11)

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. — View 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. — View Citation

Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. — View Citation

Collen FM, Wade DT, Robb GF, Bradshaw CM. The Rivermead Mobility Index: a further development of the Rivermead Motor Assessment. Int Disabil Stud. 1991 Apr-Jun;13(2):50-4. — View Citation

Hidler J, Nichols D, Pelliccio M, Brady K, Campbell DD, Kahn JH, Hornby TG. Multicenter randomized clinical trial evaluating the effectiveness of the Lokomat in subacute stroke. Neurorehabil Neural Repair. 2009 Jan;23(1):5-13. doi: 10.1177/1545968308326632. — View Citation

Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. — View Citation

Kolominsky-Rabas PL, Heuschmann PU. [Incidence, etiology and long-term prognosis of stroke]. Fortschr Neurol Psychiatr. 2002 Dec;70(12):657-62. German. — View 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. — View Citation

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. — View Citation

Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoölig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. — View Citation

Regnaux JP, Saremi K, Marehbian J, Bussel B, Dobkin BH. An accelerometry-based comparison of 2 robotic assistive devices for treadmill training of gait. Neurorehabil Neural Repair. 2008 Jul-Aug;22(4):348-54. Epub 2007 Dec 11. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Ambulation Category (FAC)		after 8 weeks	No
Secondary	Barthel Index (BI)		at week 1	No
Secondary	Barthel Index (BI)		after 4 weeks	No
Secondary	Barthel Index (BI)		after 8 weeks	No
Secondary	Barthel Index (BI)		after 24 weeks	No
Secondary	Rivermead Mobility Index (RMI)		at week 1	No
Secondary	Rivermead Mobility Index (RMI)		after 4 weeks	No
Secondary	Rivermead Mobility Index (RMI)		after 8 weeks	No
Secondary	Rivermead Mobility Index (RMI)		after 24 weeks	No
Secondary	10 metres Walking Test		at week 1	No
Secondary	10 metres Walking Test		after 4 weeks	No
Secondary	10 metres Walking Test		after 8 weeks	No
Secondary	10 metres Walking Test		after 24 weeks	No
Secondary	6 Minutes Walking Test on the Floor		at week 1	No
Secondary	6 Minutes Walking Test on the Floor		after 4 weeks	No
Secondary	6 Minutes Walking Test on the Floor		after 8 weeks	No
Secondary	6 Minutes Walking Test on the Floor		after 24 weeks	No
Secondary	6 Minutes Walking Test on the Treadmill with Body Weight Support		at week 1	No
Secondary	6 Minutes Walking Test on the Treadmill with Body Weight Support		after 4 weeks	No
Secondary	6 Minutes Walking Test on the Treadmill with Body Weight Support		after 8 weeks	No
Secondary	6 Minutes Walking Test on the Treadmill with Body Weight Support		after 24 weeks	No
Secondary	Medical Research Council (MRC)		at week 1	Yes
Secondary	Medical Research Council (MRC)		after 4 weeks	No
Secondary	Medical Research Council (MRC)		after 8 weeks	No
Secondary	Medical Research Council (MRC)		after 24 weeks	No
Secondary	Modified Ashworth Scale (mAS)		at week 1	No
Secondary	Modified Ashworth Scale (mAS)		after 4 weeks	No
Secondary	Modified Ashworth Scale (mAS)		after 8 weeks	No
Secondary	Modified Ashworth Scale (mAS)		after 24 weeks	No
Secondary	Rivermead Visual Gait Assessment (RVGA)		at week 1	No
Secondary	Rivermead Visual Gait Assessment (RVGA)		after 8 weeks	No
Secondary	Rivermead Visual Gait Assessment (RVGA)		after 24 weeks	Yes
Secondary	EuroQol 5 Dimensions (EQ-5D)		at week 1	No
Secondary	EuroQol 5 Dimensions (EQ-5D)		after 8 weeks	No
Secondary	EuroQol 5 Dimensions (EQ-5D)		after 24 weeks	No
Secondary	modified emory Functional Ambulation Profile (meFAP)		at week 1	No
Secondary	modified emory Functional Ambulation Profile (meFAP)		after 4 weeks	Yes
Secondary	modified emory Functional Ambulation Profile (meFAP)		after 8 weeks	No
Secondary	modified emory Functional Ambulation Profile (meFAP)		after 24 weeks	No
Secondary	Functional Ambulation Category (FAC)		at week 1	No
Secondary	Functional Ambulation Category (FAC)		after 4 weeks	No
Secondary	Functional Ambulation Category (FAC)		after 24 weeks	No

External Links

•   Participating Centre for the interventions GangTrainer GT1 and Conventional Physiotherapy
•   Participating Centre for the interventions GangTrainer GT1 and Conventional Physiotherapy
•   Participating Centre for the interventions Lokomat and Conventional Physiotherapy
•   Participating Centre for the interventions Lokomat and Conventional Physiotherapy
•   Participating Centre responsible for the blinded rating
•   Participating Centre responsible for the blinded rating of the visual gait analysis