Influence of HAL-training on sensory and motor function in patients with paresis of lower extremity after stroke
- Conditions
- StrokeI63.9Cerebral infarction, unspecified
- Registration Number
- DRKS00006821
- Lead Sponsor
- eurologische Klinik und Poliklinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Age within 18 - 75 years,
incomplete paresis of the leg after single incident of stroke, at least 6 months prior
1) severely impaired communication due to native language or aphasia, 2) impaired cardiorespiratory capacity, 3) neglect, 4) history of severe infection or history of infection with multiresistent bacteria (e. g. MRSA, ESBL-bacteria), 5) complete paralysis of the leg, 6) history of more than 1 stroke, 7) reduced coagulation (e. g. medication with warfarin), 8) decubital ulcer of the lower extremities and the sacral region, 9) osteoporosis, 10) history of deep vein thrombosis and pulmonary embolism, 11) contracture of the leg, 12) body weight > 100 kg, 13) epilepsy, 14) electric medial devices like cardiac pacemaker, 15) metal implants like ventricular shunt
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome:<br>- Gait parameters:<br>Time points: start of therapy, at crossover, at the end of therapy<br>Assessments: Time in 10-meter-walking-test, velocity during 10-meter-walking-test, steps during 10-meter-walking-test, distance (m) in 6-minute-walking-test, time for timed-up-and-go-test<br>
- Secondary Outcome Measures
Name Time Method Spasticity:<br>- Time points: daily, prior and after therapy, upper and lower extremities<br>- Assesment: modified Ashworth-Scale<br><br>Body function and impairment:<br>- Time points: start of therapy, crossover, end of therapy <br>- Assesment: total score of NIHS-Scale<br><br>Activity of daily life:<br>- Time points: start of therapy, crossover, end of therapy <br>- Assesment: total score of Barthel-Index and Functional Independence Measure<br><br>Activities and mobility:<br>- Time points: start of therapy, crossover, end of therapy <br>- Assesment: total score of Rivermead Mobility Index<br><br>Motor function:<br>- Time points: start of therapy, crossover, end of therapy <br>- Assesment: total Score of Fugl-Meyer Assessment für untere Extremitäten and Berg Balance Score