Moving Mindfully for Freezing of Gait (MM-RCT)

Moving Mindfully: A MBSR-Centered Approach to Freezing in Parkinson Disease - Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Mindfulness
• Intervention / Treatment: Behavioral: Mindfulness Based Walking Therapy (MBWT); Other: Freezing of Gait (FOG) Education

Detailed Description

Conduct pilot randomized clinical trial to evaluate feasibility and acceptability of the standardized Mindfulness Based Walking Therapy (MBWT) program. Using the standardized MBWT protocol devised during earlier aims of this study, the investigators will randomize 24 people with PD+FOG to MBWT or FOG education (i.e., usual care and FOG education), examining feasibility elements.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Walking Therapy (MBWT); Participants will receive the MBWT intervention.	Behavioral: Mindfulness Based Walking Therapy (MBWT); MBWT is a modified version of the Mindfulness Based Stress Reduction (MBSR) program that incorporates more walking mediations and is acceptable for people with Parkinson disease and freezing of gait.
Placebo Comparator: Freezing of Gait (FOG) Education; Participants will receive educational materials about FOG and track their usual care.	Other: Freezing of Gait (FOG) Education; Participants will receive materials to read weekly about FOG and track their usual care regimens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment of Sample: Number of Participants Recruited	The investigators will count the number of participants recruited to determine if the feasibility objective of recruitment is met. The investigators benchmark for recruitment is defined as recruiting a target sample of 24 participants to randomize.	14 weeks
Attendance of Participants: Average Number of Participants at Each Session	The investigators will count the number of enrolled participants who were in attendance at each mindfulness session and report the average percentage of participants that attended each mindfulness session over the course of the study to determine if the feasibility objective of attendance is met. The investigators benchmark for attendance is defined as at least 80% of participants attending each session. The number of sessions was 14, we then counted the number of enrolled participants who attended at each session and then averaged that number across the sessions. The unit of measure represents the average number of participants.	14 weeks
Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More	The investigators will count the number of participants who attended 11 or more of the 14 sessions (80% of the sessions). Benchmark: Retention is defined as at least 80% of participants attending 80% of the sessions.	14 weeks
Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home	The investigators will ask participants to track the number of hours spent practicing mindfulness at home to determine if the feasibility objective of adherence is met. The investigators benchmark for adherence is as completing 70% of daily home assignment hours. No homework assignments after class 12 (class 13 was the retreat).	12 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Kerri Rawson, PhD, Washington University School of Medicine; Principal Investigator: Gammon Earhart, PhD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Actual): April 26, 2024
• Study Completion (Actual): April 26, 2024

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 202304132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No