Moving Mindfully: A MBSR-Centered Approach to Freezing in Parkinson Disease - Randomized Control Trial
Phase: NA
Conditions: Parkinson Disease, Mindfulness
Sponsor: Washington University School of Medicine

Moving Mindfully for Freezing of Gait 
NCT05923229 
Protocol 
04/18/2023 

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Moving Forward: Protocol v1 04/18/2023 
RESEARCH DESIGN AND METHODS 
 
Note: Aim 1/Aim 2 are listed under CT Record #NCT05309083 titled Moving Mindfully for Freezing with 
Parkinson’s 
Aim 3: Conduct pilot RCT trial to evaluate feasibility and acceptability of the standardized 
Mindfulness-Based Walking Therapy (MBWT) program. Using the standardized MBWT manual produced 
from Aim 2, we will randomize 24 people with Parkinson Disease + Freezing of Gait (PD+FOG) to MBWT or 
FOG education group (i.e., usual care and FOG education), examining feasibility elements listed in Aim 2.  
RATIONALE 
Our main goal in Aim 3 is to conduct a formative evaluation of the intervention by gathering information 
before, during, and after a controlled pilot study. Results from this pilot will allow us to further improve the 
protocol and inform implementation of the intervention in a future larger trial, if warranted.  
DESIGN 
We will recruit and randomize 24 participants with PD+FOG to the standardized MBWT program or FOG 
education (12 per group). Participants in both groups will undergo three evaluations sessions: 1-4 weeks 
prior to the intervention (Pre-test), 1-4 weeks after the intervention (Post-test), and 14-18 weeks after the 
intervention (Follow-up).  
The FOG education group will receive customary care from their health professional team, which may 
include alterations to anti-Parkinson medications, and they will receive weekly education and information 
on resources about FOG. For early phase RCTs that aim to determine if an intervention works at all, the 
NIH expert panel’s discussion of comparator selection in Freedland et al., recommends a low formidability 
comparator such as no treatment or waitlist. For RCTs that seek to determine how well the intervention 
works relative to an alternative intervention, the panel recommends usual care that reflects existing 
clinical services, a well-established alternative intervention, or a variation of the experimental 
intervention. Currently there are no universal care standards for FOG thus a well-established alternative 
intervention is not available and it would not be feasible to test a variation of a protocol currently being 
developed. Thus, we have selected to utilize a usual care group that reflects existing clinical services for 
management of FOG. 
KEY FEASIBILITY ELEMENTS, EXPECTED OUTCOMES, AND BENCHMARKS FOR MBWT 
Ability to recruit our target sample. We estimate screening approximately 85 participants by phone to 
find 30 participants that pass the phone screen. This anticipated screening rate of 35% is based on our 
recent interventions. We anticipate six people will not pass screening, leaving 24 people to be randomized. 
We anticipate four people will decide not to participate after randomization leaving twenty participants 
that begin the interventions. We will track reasons for not continuing during the phone screens. 
Benchmark: (1) Recruitment of 24 participants. 
Participant attendance and retention: We will collect data on why mindfulness classes are missed and 
reasons for drop-outs, if any. Make up classes may need to be scheduled. Benchmarks: (2) Attendance 
and retention of participants, defined as 80% of participants attending 80% of the sessions.  
Participant adherence. Adherence for mindfulness home practice will be monitored using a paper form. 
The participants will note how many minutes they practiced mindfulness today. Benchmark: (3) Home 

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practice adherence, at least 70% of participants will complete at least 70% of the daily home 
assignments during the active intervention period. Number of home practice hours is 18 hours over the 
course of the mindfulness intervention. 
 
 
INCLUSION/EXCLUSION CRITERIA  
(These criteria will be formally reviewed during the advisory group meetings and an IRB update will be 
conducted before enrollment):  
Participants with PD will meet the following inclusion criteria:  
• diagnosed by a neurologist with idiopathic PD;  
• age 50 and older;  
• a score on the Hoehn & Yahr (H&Y) scale between I-IV;  
• history of freezing of gait;  
• able to provide informed consent;  
• able to walk independently with or without an assistive device for at least five minutes;  
• experience fear and/or worry in relation to their FOG; and 
• stable medication regimen for two months prior to enrollment.  
Participants with PD will be excluded if they have any of the following:   
• evidence of dementia (Montreal Cognitive Assessment – Telephone Version < 13) to ensure 
understanding of materials;  
• are under consideration for deep brain stimulation surgery within the next six months;  
• neurologic condition other than PD;  
• inability to cooperate with the protocol;  
• language, visual, or hearing barriers to participation; or 
• history of orthopedic or other medical problems that limit ability to participate safely in the 
intervention.