DRKS00025691
Recruiting
未知
Examination of a sensor-based mobility assistent to treat gait disorders in patients with Morbus Parkinson - Mobil4Park
SensorStim Neurotechnology GmbH0 sites12 target enrollmentJune 25, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- G20
- Sponsor
- SensorStim Neurotechnology GmbH
- Enrollment
- 12
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Only people who are legally competent and able to understand the goals, procedure and risks of the clinical study and who gave written informed consent to participate in the study.
- •Confirmed diagnose with ideopathic Parkinsons Syndrome
- •Sex/Age: Male patients between 40 – 85 years and women between 50 \- 85 years who confirmed that they are postmenopausal
- •Manifested gait disorder with Freezing of Gait (FoG) smptoms (Freezing of Gait Questionnaire \- Item 3: two or more points)
- •Able to walk at least 200 m
Exclusion Criteria
- •People, who live in an institution due to official or judicial request.
- •People, who are clinical investigators or sponsor of the study or who are otherwise related to the clinical investigation site.
- •People, who have an active infection with SARS\-CoV\-2\.
- •Motor symptoms caused by another neurological disease (e.g. Multiple
- •Sklerosis, Stroke)
- •Open wounds, tumors, injuries or implants in the area of electrical stimulation (lower leg)
- •Impaired sensory perception of the legs (e.g. Polyneurpathy, spinal stenosis or nerve root compression)
- •Visible edema in the area of the lower legs
- •Dementia (MMST \< 24 Points)
- •All implanted electric stimulation devices, e.g. cardiac defibrillators or pacers, deep brain stimulation devices (DBS)
Outcomes
Primary Outcomes
Not specified
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