Moving Mindfully for Freezing of Gait (MM-RCT)

The Washington University

Status: Completed

Conditions: Mindfulness; Parkinson Disease

Treatments: Other: Freezing of Gait (FOG) Education; Behavioral: Mindfulness Based Walking Therapy (MBWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05923229

202304132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups, including a placebo group

Mindfulness-Based Walking Therapy (MBWT)

Experimental group

Description:

Participants will receive the MBWT intervention.

Treatment:

Behavioral: Mindfulness Based Walking Therapy (MBWT)

Freezing of Gait (FOG) Education

Placebo Comparator group

Description:

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

Treatment:

Other: Freezing of Gait (FOG) Education