Status:
SUSPENDED
Comparative Study of GangTrainer GT1, Lokomat and Conventional Physiotherapy
Lead Sponsor:
Research Department for Neurorehabilitation South Tyrol
Collaborating Sponsors:
Privatklinik Villa Melitta
Hochzirl Hospital
Conditions:
Stroke, Acute
Eligibility:
All Genders
18-79 years
Phase:
NA
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 on...
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, haem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01146587
Start Date
August 1 2010
End Date
February 1 2016
Last Update
June 8 2015
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Hochzirl Hospital
Hochzirl, Tyrol, Austria, 6170
2
Claudiana Landesfachhochschule
Bolzano, Südtirol, Italy, 39100
3
Krankenhaus Bozen
Bolzano, Südtirol, Italy, 39100
4
Privatklinik Villa Melitta
Bolzano, Südtirol, Italy, 39100