Parkinson' disease
Conditions
Interventions
None listed
Sponsors
Tel Aviv Sourasky Medical Center
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, all subject must meet all of the following criteria: 1. Voluntary written informed consent of the participant or their legally authorized repre-sentative has been obtained prior to any screening procedures; 2. At least 18 years of age at the time of signing the Informed Consent Form (ICF); 3. Able to read and write in the first language of their respective country; 4. Able to consent and comply with any study specific procedure. Participants with Parkinson*s disease must also meet all of the following criteria: 1. Diagnosis of idiopathic Parkinson*s disease (PD) made by a neurologist according to the Movement Disorders Society guidelines; 2. Able to walk independently for a distance of 10 meters, without walking aid; 3. Absence of a Deep Brain Stimulator; 4. Stable PD treatment in the 4 weeks prior to participation that is not expected to change in the course of the study. 5. For patients with FOG: a score of >= 1 on the New Freezing Of Gait Questionnaire (NFOG-Q). Participants without Parkinson*s disease (caregiver/observer) must meet all of the following criteria: 1. Be a family member or close friend of the participant with Parkinson*s disease; 2. Have had a minimal interaction of 3 times/week in the past month with the participant with Parkinson*s disease.
Exclusion criteria
Exclusion criteria: 1. Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncon-trolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse, other neurological (than PD) or orthopaedic im-pairment that significantly impacts on gait. 2. Unwilling to temporarily delay the morning anti-Parkinsonian medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameters are the ClinRO and PRO. The primary endpoints will be criterion validity and intra-rater reliability of the ClinRO. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Inter-rater reliability of ClinRO & PRO • Test-retest reliability of ClinRO & PRO • Construct validity of ClinRO & PRO • Responsiveness to dopaminergic medication of the ClinRO | — |
Countries
Netherlands
Outcome results
None listed