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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Walking Therapy (MBWT) | Experimental | Participants will receive the MBWT intervention. |
|
| Freezing of Gait (FOG) Education | Placebo Comparator | Participants will receive educational materials about FOG and track their usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Walking Therapy (MBWT) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Attendance of Participants: Average Number of Participants at Each Session | The investigators will count the number of enrolled participants who were in attendance at each mindfulness session and report the average percentage of participants that attended each mindfulness session over the course of the study 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. The number of sessions was 14, we then counted the number of enrolled participants who attended at each session and then averaged that number across the sessions. The unit of measure represents the average number of participants. | 14 weeks |
| Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More | The investigators will count the number of participants who attended 11 or more of the 14 sessions (80% of the sessions). Benchmark: Retention is defined as at least 80% of participants attending 80% of the sessions. | 14 weeks |
| Adherence: Average Percentage of Hours Participants Practiced 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 as completing 70% of daily home assignment hours. No homework assignments after class 12 (class 13 was the retreat). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gammon Earhart, PhD | Washington University School of Medicine | Principal Investigator |
| Kerri Rawson, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
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We consented people via an online format and conducted phone interview screening prior to in-person evaluations. Participants were excluded after the phone interview if they had significant cognitive impairment (MOCA-Telephone Version <13, noted they were not diagnosed with idiopathic Parkinson disease, or could not walk more than five minutes.
Recruitment began in May 2023 and concluded in August 2023. Recruitment locations included recruitment flyers at physical therapy and movement disorder clinics, health fairs and events, and support groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Based Walking Therapy (MBWT) | Participants will receive the MBWT intervention. |
| FG001 | Freezing of Gait (FOG) Education | Participants will receive educational materials about FOG and track their usual care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-Based Walking Therapy (MBWT) | Participants will receive the MBWT intervention. |
| BG001 | Freezing of Gait (FOG) Education | Participants will receive educational materials about FOG and track their usual care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 14 weeks |
|
8 months
Injuries that occurred during class time or during the evaluations were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-Based Walking Therapy (MBWT) | Participants will receive the MBWT intervention. 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. |
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Some participants in the Mindfulness-Based Walking Therapy intervention did not return the weekly tracking forms noting the hours they practiced mindfulness at home.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kerri Rawson | Washington University School of Medicine | 314-273-1053 | rawson@wustl.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2023 | May 28, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2023 | Apr 15, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014887 | Weather |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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| Freezing of Gait (FOG) Education | Other | Participants will receive materials to read weekly about FOG and track their usual care regimens. |
|
| BG002 | Total | Total of all reporting groups |
| years of age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| New Freezing of Gait Questionnaire (N-FOG) | The New Freezing of Gait Questionnaire quantifies severity of freezing of gait with a total range of 0 to 28. Higher scores indicate more severe freezing of gait. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Attendance of Participants: Average Number of Participants at Each Session | The investigators will count the number of enrolled participants who were in attendance at each mindfulness session and report the average percentage of participants that attended each mindfulness session over the course of the study 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. The number of sessions was 14, we then counted the number of enrolled participants who attended at each session and then averaged that number across the sessions. The unit of measure represents the average number of participants. | 7 participants who did not withdraw from the 14 week program and 5 participants who withdrew (1 after session 1, 1 after session 2, 1 after session 4, 1 after session 5, 1 after session 7) | Posted | Mean | Full Range | percentage of participants | 14 weeks | sessions | sessions |
|
|
|
| Primary | Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More | The investigators will count the number of participants who attended 11 or more of the 14 sessions (80% of the sessions). Benchmark: Retention is defined as at least 80% of participants attending 80% of the sessions. | 12 participants (7 participants who did not withdraw and 5 participant who withdrew) | Posted | Count of Participants | Participants | 14 weeks |
|
|
|
| Primary | Adherence: Average Percentage of Hours Participants Practiced 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 as completing 70% of daily home assignment hours. No homework assignments after class 12 (class 13 was the retreat). | Only 5 of the 7 participants who did not withdraw and 1 participant who did withdraw submitted tracking forms for 6 or more weeks. | Posted | Mean | Full Range | percentage of home assignment hours | 12 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Freezing of Gait (FOG) Education | Participants will receive educational materials about FOG and track their usual care. Freezing of Gait (FOG) Education: Participants will receive materials to read weekly about FOG and track their usual care regimens. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |