Influence of a multidisciplinary therapy on quality of life, motor and other functions in Patients with Parkinson's Disease

Completed

• Conditions: G20; Parkinson disease

• Registration Number: DRKS00013361
• Lead Sponsor: St. Josef-Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-08
• Study Completion: 2018-09-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

written consent form based on Good Clinical Practice (GCP) and the local legislation
- male and female patients with idiopathic Parkinson's Disease based on the criteria of the Parkinson's Disease Society Brain Bank
- patients have to be willing and able to participate in the psychometric and motor examinations

Exclusion Criteria

- atypical Parkinson's Syndromes (medicinal, metabolic, inflammatory or degenerative)
- stereotactic surgery in the medical history
- electroconvulsive therapy in the past 180 days before the screening
- pregnancy, planned pregnancy or breastfeeding
- missing consent with the protocol
- severe dementia on the basis of a score <10 in the Mini-Mental-State-Examination (MMSE)
- acute psychotic disorder (beginning hallucinations or psychotic episodes are no exclusion criterion)
- depression with suicidal ideation (former episodes of severe depression are no exclusion criterion)
- drug or alcohol addiction (drug addiction: constant or sporadic abuse without any medical indication or with paradox medical indication or in an unreasonable amount. Addictive consumption of e.g. alcohol, cannabis, amphetamine, inhalants, cocaine, heroin, crack. Alcohol addiction: men >40 g/day; women >30 g/day)
- illiteracy or insufficient language skills to complete the questionnaires

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of clinical condition assessed by the Clinical Global Impression Scale - Global Change (CGI-C) rated by doctor and patient immediately at the end of treatment and at a 6 week follow-up.

Secondary Outcome Measures

Name	Time	Method
Assessment of the following secondary outcomes at start and end of the therapy, as well as 6 weeks after the end of the therapy: <br>- score of UPDRS-III (motor examination): Unified Parkinson’s Disease Rating Scale<br>- EQ-5D-5L (quality of life in general)<br>- PDQ-39 (quality of life in PD patients)<br>- Record of expectations of patients and caregivers towards the 'Parkinson's complex therapy', evaluation of their satisfaction<br>- further aspects