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Completed

NCT Number: NCT05923229

Moving Mindfully for Freezing of Gait

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mindfulness Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Freezing of Gait (FOG) Education

Other

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

Primary outcomes

  1. Recruitment of Sample: Number of Participants Recruited

    Time frame: 14 weeks

    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.

  2. Attendance of Participants: Average Number of Participants at Each Session

    Time frame: 14 weeks

    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.

  3. Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More

    Time frame: 14 weeks

    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.

  4. Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home

    Time frame: 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: MM-RCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2023
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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