N/A
N=24
Moving Mindfully for Freezing of Gait
Parkinson Disease · Mindfulness
Bottom Line
View on ClinicalTrials.gov: NCT05923229 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Recruitment of Sample: Number of Participants Recruited — 12; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Based Walking Therapy (MBWT) (Behavioral); Freezing of Gait (FOG) Education (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment of Sample: Number of Participants Recruited |
12; 12 | — |
| PRIMARY Attendance of Participants: Average Number of Participants at Each Session |
88.46 | — |
| PRIMARY Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More |
6 | — |
| PRIMARY Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home |
89.54 | — |
Summary
The investigators will conduct an randomized controlled trial (RCT) among people with Parkinson disease (PD) and freezing of gait (FOG) to evaluate the feasibility of a mindfulness intervention compared to a educational program about FOG. FOG is a severe motor disturbance that prevents people from stepping normally and is associated with anxiety, frustration, sedentary behaviors, poorer quality of life, and falls. Mindfulness-Based Stress Reduction (MBSR) is an evidence-based practice that creates a culture to reduce stress and anxiety by increasing conscious awareness and self-compassion. In this study, the investigators will develop a mindfulness-based walking intervention to address both mental health and mobility challenges that constitute FOG.
Eligibility Criteria
Inclusion Criteria
- diagnosed by a neurologist with idiopathic Parkinson disease;
- 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;
- experience fear or worry in relation to their freezing of gait;
- able to walk independently with or without an assistive device for at least five minutes; and
- stable medication regimen for one month prior to enrollment.
Exclusion Criteria
- have evidence of dementia (Montreal Cognitive Assessment (MOCA) - 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.
Data sourced from ClinicalTrials.gov (NCT05923229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.