Moving Mindfully for Freezing of Gait

Parkinson Disease Clinical Trial

— MM-RCT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05923229
• Other study ID #: 202304132
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 usual care (i.e., medical management and FOG education), examining feasibility elements. The investigators will also conduct follow-up evaluations to monitor burden and continued usage of mindfulness.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• diagnosed by a neurologist with idiopathic Parkinson disease;
• age 55 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) < 18) 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.

Related Conditions & MeSH terms

• Mindfulness
• Parkinson Disease

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.

Other:
• Freezing of Gait (FOG) Education
Participants will receive materials to read weekly about FOG and track their usual care regimens.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Attendance of Participants: Number of Participants at Each Session	The investigators will count the number of participants at each session 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.	14 weeks
Primary	Retention of Participants: Number of Sessions Each Participant Completes	The investigators will count the number of sessions each participant attends to determine if the feasibility objective of retention is met. The investigators benchmark for retention is defined as participants 80% of the sessions.	14 weeks
Primary	Adherence: Number of Hours Participants Practice 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 defined as participants completing 70% of daily home assignment hours.	14 weeks