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Moving Mindfully for Freezing in Parkinsons (MMR34)

Primary Purpose

Parkinson Disease, Freezing of Gait

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Walking Therapy (MBWT)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Mindfulness

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 two months 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 Medicine Program in Physical Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness Based Walking Therapy (MBWT)

Arm Description

Participants will participate in MBWT.

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 12 participants.
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 attending 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

First Posted
March 16, 2022
Last Updated
July 11, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05309083
Brief Title
Moving Mindfully for Freezing in Parkinsons
Acronym
MMR34
Official Title
Moving Mindfully: A MBSR-Centered Approach to Freezing in Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)

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 modify and evaluate the feasibility of a mindfulness intervention among people living with Parkinson disease (PD) and freezing of gait (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. This R34 feasibility study includes three aims to permit the development of a mind and body approach for FOG among people living with PD.
Detailed Description
Aim 1: Create a Mindfulness-Based Walking Therapy (MBWT) program by modifying the MBSR standard protocol based upon feedback from an advisory group. An advisory group consisting of physical therapists, mindfulness instructors, research team members, 3-5 people with PD+FOG and care partners will modify the standard MBSR program over a twelve-week period to make it acceptable and feasible for people with PD+FOG and shift the focus from sitting, standing, or lying meditations to walking mediations. Aim 2: Refine and standardize the MBWT protocol to ensure feasibility and acceptability through open pilot testing. Twelve participants with PD+FOG will participate in an open pilot of the MBWT program. The MBWT program will then be modified based on participant feedback to produce a standardized MBWT to use in Aim 3. Feasibility elements include meeting benchmarks for: 1) recruitment and randomization; 2) retention and satisfaction; 3) delivery of the intervention; 4) participant adherence using technology; 5) evaluating clarity and burden of outcome assessments; and 6) monitoring adverse events. Aim 3: Conduct pilot randomized clinical trial to evaluate feasibility and acceptability of the standardized MBWT program. Using the standardized MBWT protocol produced from Aim 2, the investigators will randomize 24 people with PD+FOG to MBWT or usual care (i.e., medical management and FOG education), examining feasibility elements listed in Aim 2. 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, Freezing of Gait
Keywords
Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In Aim 2, participants will receive the mindfulness intervention as part of the open pilot.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Walking Therapy (MBWT)
Arm Type
Experimental
Arm Description
Participants will participate in MBWT.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Walking Therapy (MBWT)
Intervention Description
MBWT will be a modified form of the typical Mindfulness Based Stress Reduction (MBSR) program that incorporates more walking meditations and is acceptable for people with Parkinson disease and freezing of gait.
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 12 participants.
Time Frame
12 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
12 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 attending 80% of the sessions.
Time Frame
12 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
12 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 two months 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gammon Earhart, PT, 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 Program in Physical Therapy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Moving Mindfully for Freezing in Parkinsons

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