Moving Mindfully for Freezing of Gait

NCT05923229 | Completed Results DMC

• 1 other identifier: 202304132
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Mindfulness

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Mindfulness-Based Walking Therapy (MBWT)

EXPERIMENTAL

Participants will receive the MBWT intervention.

Behavioral: Mindfulness Based Walking Therapy (MBWT)

Freezing of Gait (FOG) Education

PLACEBO COMPARATOR

Participants will receive educational materials about FOG and track their usual care.

Other: Freezing of Gait (FOG) Education

Interventions

Mindfulness Based Walking Therapy (MBWT) BEHAVIORAL

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.

Mindfulness-Based Walking Therapy (MBWT)

Freezing of Gait (FOG) Education OTHER

Participants will receive materials to read weekly about FOG and track their usual care regimens.

Freezing of Gait (FOG) Education

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Weather; Educational Status

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Socioeconomic Factors; Population Characteristics

Limitations and Caveats

Some participants in the Mindfulness-Based Walking Therapy intervention did not return the weekly tracking forms noting the hours they practiced mindfulness at home.

Results Point of Contact

• Title: Kerri Rawson
• Organization: Washington University School of Medicine

rawson@wustl.edu

314-273-1053

Study Officials

• Gammon Earhart, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Kerri Rawson, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: June 7, 2023
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)