An international multimodal protocol for the evaluation of freezing or gait in persons with Parkinson*s disease
- Conditions
- Parkinson' disease10028037
- Registration Number
- NL-OMON56869
- Lead Sponsor
- Tel Aviv Sourasky Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
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.
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameters are the ClinRO and PRO. The primary endpoints will be<br /><br>criterion validity and intra-rater reliability of the ClinRO.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Inter-rater reliability of ClinRO & PRO<br /><br>• Test-retest reliability of ClinRO & PRO<br /><br>• Construct validity of ClinRO & PRO<br /><br>• Responsiveness to dopaminergic medication of the ClinRO</p><br>