Moving Mindfully for Freezing of Gait

NCT ID: NCT05923229

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-07
• Study Completion Date: 2024-04-26

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.

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.

Conditions

Parkinson Disease; Mindfulness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Mindfulness-Based Walking Therapy (MBWT)

Participants will receive the MBWT intervention.

Group Type: EXPERIMENTAL

Mindfulness Based Walking Therapy (MBWT)

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Freezing of Gait (FOG) Education

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Freezing of Gait (FOG) Education

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Gammon M Earhart

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gammon Earhart, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Kerri Rawson, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

202304132

Identifier Type: -

Identifier Source: org_study_id