Examination of a sensor-based mobility assistent to treat gait disorders in patients with Morbus Parkinso

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 12

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)
• Epilepsy
• All implanted electric stimulation devices, e.g. cardiac defibrillators or pacers, deep brain stimulation devices (DBS)
• History of severe cardiac arrhythmias such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation with tachyarrhythmia absoluta). Stable patients with atrial fibrillation can be included in the study, if the cardiologist of the patient agrees. Atrial fibtillation is no contraindication for the use of the M4P-system.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average trial time (in seconds) in the clinical gait assessment 'Freezing Assessment Course'

Secondary Outcome Measures

Name	Time	Method
Measurements of the clinical gait tests (10m-walking test and Freezing Assessment Course): <br>• Time (in Sec)<br>• Number of steps<br>• Number of detected Freezing of Gait (FoG) steps<br>• Number of stimulated steps<br>• Duration of adaptive stimulation (in sec)<br>• Duration of rhythmic stimulation (in sec)<br>• Number of adaptive stimulation episodes <br>• Number of rhythmic stimulation episodes <br>• Objective gait parameters (measurements of the sensors)<br>• Score of the Freezing Assessment Course<br>• Questionnaire Usability (qualitative evaluation)<br>• Questionnaire subjective usefulness (qualitative evaluation)