Automated recording of movement profiles of patients with Parkinson's syndromes

• Conditions: G20; Parkinson disease

• Registration Number: DRKS00020948
• Lead Sponsor: St. Josef-Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-30
• Study Completion: 2022-10-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Male and female patients with idiopathic Parkinson's syndrome according to UK Brain Bank criteria

Further inclusion criteria:
- Written informed consent based on Good Clinical Practice (GCP) and local legislation
- Age of majority
- Reconnaissance capability
- Legal capacity

Exclusion Criteria

- Lack of agreement with protocol
- Drugs or alcohol dependency within 6 months before signing the consent form
- Stereotactic surgery in the history
- Electroconvulsive therapy in the last 180 days before screening
- Severe dementia based on a score of <10 in the Mini Mental State Examination (MMSE)
- Depression with suicidal thoughts (previous episodes of severe depression are not a criterion for exclusion)
- Illiteracy or insufficient language skills

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the effectiveness of sensor-based parameters for the evaluation of treatment success in motor, gait and executive dysfunctions of Parkinson's patients.<br>The questionnaires as well as the sensor measurements are collected at the beginning of the therapy, time T1, and at the end of the therapy, time T2.

Secondary Outcome Measures

Name	Time	Method
- Determination of output values of sensor-based parameters for the evaluation of motor, gait and executive function disorders in Parkinson's patients <br>- Determination of the reproducibility of sensor-based parameters for motor, gait and executive dysfunctions in patients, which is necessary for the calculation of the minimal detectable change and thus for the detection of an effective treatment<br>- Exploratory comparison of the above parameters / changes in parameters during the course of treatment, with clinical and quantitative imaging parameters.<br>The questionnaires as well as the sensor measurements are collected at the beginning of the therapy, time T1, and at the end of the therapy, time T2.