Back to resultsMoving Mindfully for Freezing of Gait (MM-RCT)
Primary Purpose
Parkinson Disease, Mindfulness
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Walking Therapy (MBWT)
Freezing of Gait (FOG) Education
Sponsored by
About this trial
This is an interventional health services research trial for Parkinson Disease
Eligibility Criteria
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.
Sites / Locations
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mindfulness-Based Walking Therapy (MBWT)
Freezing of Gait (FOG) Education
Arm Description
Participants will receive the MBWT intervention.
Participants will receive educational materials about FOG and track their usual care.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05923229
First Posted
June 19, 2023
Last Updated
June 27, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05923229
Brief Title
Moving Mindfully for Freezing of Gait
Acronym
MM-RCT
Official Title
Moving Mindfully: A MBSR-Centered Approach to Freezing in Parkinson Disease - Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Mindfulness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Based Walking Therapy (MBWT)
Arm Type
Experimental
Arm Description
Participants will receive the MBWT intervention.
Arm Title
Freezing of Gait (FOG) Education
Arm Type
Placebo Comparator
Arm Description
Participants will receive educational materials about FOG and track their usual care.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Walking Therapy (MBWT)
Intervention Description
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
Other
Intervention Name(s)
Freezing of Gait (FOG) Education
Intervention Description
Participants will receive materials to read weekly about FOG and track their usual care regimens.
Primary Outcome Measure Information:
Title
Recruitment of Sample: Number of Participants Recruited
Description
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.
Time Frame
14 weeks
Title
Attendance of Participants: Number of Participants at Each Session
Description
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.
Time Frame
14 weeks
Title
Retention of Participants: Number of Sessions Each Participant Completes
Description
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.
Time Frame
14 weeks
Title
Adherence: Number of Hours Participants Practice Mindfulness at Home
Description
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.
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerri Rawson, PhD
Phone
813-468-8900
Email
rawson@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Hessler
Phone
314-286-1478
Email
mjhessler@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gammon Earhart, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kerri Rawson, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Hessler
Phone
314-278-1478
Email
mjhessler@wustl.edu
First Name & Middle Initial & Last Name & Degree
Gammon Earhart, PhD
First Name & Middle Initial & Last Name & Degree
Kerri Rawson, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Moving Mindfully for Freezing of Gait
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