To determine whether the ClinRO and PRO are valid and reliable measures for use in intervention trials, specifically:1. Evaluate the reliability and validity of the proposed ClinRO protocol to assess freezing of gait in individuals living with…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters are the ClinRO and PRO. The primary endpoints will be
criterion validity and intra-rater reliability of the ClinRO.
Secondary outcome
• Inter-rater reliability of ClinRO & PRO
• Test-retest reliability of ClinRO & PRO
• Construct validity of ClinRO & PRO
• Responsiveness to dopaminergic medication of the ClinRO
Background summary
Freezing of gait (FOG) affects most people with Parkinson*s disease (PD).
Accurate assessment and measurement of FOG severity and its impact on daily
life are critical to evaluate and develop new effective treatments. However,
currently, there is no clinician-reported outcome (ClinRO) measure that can be
reliably used as an endpoint to detect meaningful improvement, severely
limiting clinical trials of FOG. As an outcome of an international working
group, a new standardised assessment and outcomes were developed (ClinRO).
Before using this assessment in clinical practice and research, it is important
to provide appropriate evidence on its measurement properties. Previous
attempts at quantifying FOG using self-report questionnaires failed to
accurately reflect symptom severity and generated high test-retest measurement
errors. These approaches also do not fully capture the patient*s perspectives
on the impact of FOG on their quality of life. A new patient-reported outcome
(PRO) is needed to address these limitations and ensure that the changes
detected are consequential and meaningful to patients.
Study objective
To determine whether the ClinRO and PRO are valid and reliable measures for use
in intervention trials, specifically:
1. Evaluate the reliability and validity of the proposed ClinRO protocol to
assess freezing of gait in individuals living with Parkinson's disease;
2. Assess the test-retest reliability of the ClinRO to determine whether it is
stable over time and valid;
3. Assess the test-retest reliability of a newly developed PRO to determine
whether it is stable over time and valid;
4. Determine the Minimal Detectable Change (MDC) value for the ClinRO and PRO
to enable reliable quantification of change over time;
5. Assess the convergent validity of the ClinRO and PRO by demonstrating a
correlation between similar outcomes.
Study design
This study is a (cross-sectional) validation study of a novel Parkinson*s
Disease-specific rating scale for Freezing of Gait. The study is part of an
international task force (Project leader: Prof. Jeffrey M. Hausdorff, Tel Aviv
Sourasky Medical Center, Tel Aviv, Israël).
Study burden and risks
Burden: The assessments will last 3 hours.
Risks: People with PD are generally exposed to an increased risk of falls
compared to age-matched controls. As this study is a validation study and no
intervention is introduced, we do not expect additional risks within this
study. The individual items of the ClinRO are inspired by clinical balance and
gait tasks that are part of routine assessment.
Weizmann St 6
Tel Aviv-Yafo na
IL
Weizmann St 6
Tel Aviv-Yafo na
IL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86875.091.24 |