*Managing the mental state* to tackle anxiety-related freezing of gait in people with Parkinson*s disease: a randomized controlled intervention trial
Recruiting
- Conditions
- Parkinson's10028037
- Registration Number
- NL-OMON56264
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
-Men/women of age > 18 years with idiopathic Parkinson*s disease, as diagnosed
by the UK Brain Bank Criteria.
-Presence of daily FOG (as objectified with the new-freezing of gait
questionnaire), that is related to anxiety (positive answer to the question:
Does FOG occur -or get worse- when you are anxious or stressed?).
-Written informed consent.
Exclusion Criteria
-Any comorbidity (i.e. neurological, orthopedic) that significantly impacts
gait.
-Severe cognitive impairment hampering the ability to comply to the study
protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is the subjective impact of anxiety and stress on<br /><br>FOG, as measured with a 7-point Likert scale. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes involve the perceived levels of anxiety, and the percentage<br /><br>of time frozen during a home-based gait task within a participant self-selected<br /><br>FOG *hotspot* in the home setting and during a standardized FOG-provoking gait<br /><br>protocol, which includes rapid 360 degrees turning in both directions,<br /><br>navigating a narrow passage, and performing a cognitive (serial subtraction)<br /><br>dual-task to assess freezing severity. Participants will also fill in several<br /><br>questionnaires. Additionally, upon completion of all other measures, we will<br /><br>perform in-depth interviews and perform a thematic analysis on these data to<br /><br>evaluate patients* interpretations of the intervention material, ways in which<br /><br>they feel it relates/related to them, and the degree to which it was (not)<br /><br>effective.</p><br>