Parkinson DiseaseMM-RCTNCT05923229

Moving Mindfully for Freezing of Gait

A study testing Mindfulness Based Walking Therapy (MBWT) and Freezing of Gait (FOG) Education in people with Parkinson Disease and Mindfulness, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Parkinson Disease, Mindfulness
What is being tested?: Mindfulness Based Walking Therapy (MBWT) and Freezing of Gait (FOG) Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 7 Jun 2023to 26 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63108

Other trials in United States

About this study

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

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.

Read the 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 FOG education (i.e., usual care and FOG education), examining feasibility elements.

Conditions: Parkinson Disease, Mindfulness
Being tested: Mindfulness Based Walking Therapy (MBWT), Freezing of Gait (FOG) Education
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness Based Walking Therapy (MBWT)Behavioural
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.
Freezing of Gait (FOG) EducationOther
Participants will receive materials to read weekly about FOG and track their usual care regimens.

Study groups in NCT05923229
Study group	Role	What they receive
Mindfulness-Based Walking Therapy (MBWT)	Experimental	Participants will receive the MBWT intervention. Receives: Behavioral: Mindfulness Based Walking Therapy (MBWT)
Freezing of Gait (FOG) Education	Placebo comparator	Participants will receive educational materials about FOG and track their usual care. Receives: Other: Freezing of Gait (FOG) Education

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 202326 Apr 2024

First posted28 Jun 2023
Study start7 Jun 2023
Primary completion26 Apr 2024
Study completion26 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05923229
Sponsor's protocol ID: 202304132
Acronym: MM-RCT
Status last verified: May 2025
First submitted: 19 Jun 2023
Last updated: 17 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease
Parkinson Disease
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 1
Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients
Parkinson Disease, Parkinson's Disease
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer

All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Moving Mindfully: A MBSR-Centered Approach to Freezing in Parkinson Disease - Randomized Control Trial
ClinicalTrials.gov ID: NCT05923229
Acronym / sponsor ID: MM-RCT / 202304132
Conditions: Parkinson Disease, Mindfulness
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 7 Jun 2023 (actual)
Primary completion: 26 Apr 2024 (actual)
Study completion: 26 Apr 2024 (actual)
First posted: 28 Jun 2023 (actual)
Results: Posted 17 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mindfulness-Based Walking Therapy (MBWT)	Experimental	Behavioral: Mindfulness Based Walking Therapy (MBWT)Participants will receive the MBWT intervention.
Freezing of Gait (FOG) Education	Placebo comparator	Other: Freezing of Gait (FOG) EducationParticipants will receive educational materials about FOG and track their usual care.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Mindfulness-Based Walking Therapy (MBWT)
Freezing of Gait (FOG) EducationParticipants will receive materials to read weekly about FOG and track their usual care regimens.	Other	Freezing of Gait (FOG) Education

Primary outcome

Recruitment of Sample: Number of Participants Recruited
Time frame: 14 weeks
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: Average Number of Participants at Each Session
Time frame: 14 weeks
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.
Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More
Time frame: 14 weeks
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.
Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home
Time frame: 12 weeks
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).

Results and safety

Results posted to the registry on 17 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness-Based Walking Therapy (MBWT)	12	7
Freezing of Gait (FOG) Education	12	11

Primary outcome: Recruitment of Sample: Number of Participants Recruited

Time frame: 14 weeks. Count of participants. Unit: Participants

Measure	Mindfulness-Based Walking Therapy (MBWT) n = 12	Freezing of Gait (FOG) Education n = 12
Value	12	12

Primary outcome: Attendance of Participants: Average Number of Participants at Each Session

Time frame: 14 weeks. Mean (Full Range). Unit: percentage of participants

Measure	Mindfulness-Based Walking Therapy (MBWT) n = 12
Value	88.46 (71.43 to 100)

Population analysed: 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)

Primary outcome: Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More

Time frame: 14 weeks. Count of participants. Unit: Participants

Measure	Mindfulness-Based Walking Therapy (MBWT) n = 12
Value	6

Population analysed: 12 participants (7 participants who did not withdraw and 5 participant who withdrew)

Primary outcome: Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home

Time frame: 12 weeks. Mean (Full Range). Unit: percentage of home assignment hours

Measure	Mindfulness-Based Walking Therapy (MBWT) n = 6
Value	89.54 (53 to 247.90)

Population analysed: Only 5 of the 7 participants who did not withdraw and 1 participant who did withdraw submitted tracking forms for 6 or more weeks.

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness-Based Walking Therapy (MBWT)	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Freezing of Gait (FOG) Education	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): Some participants in the Mindfulness-Based Walking Therapy intervention did not return the weekly tracking forms noting the hours they practiced mindfulness at home.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Parkinson Disease

Not yet recruiting
Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease
Parkinson Disease
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 1
Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients
Parkinson Disease, Parkinson's Disease
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gammon Earhart, PhD principal investigator

Washington University School of Medicine

Kerri Rawson, PhD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment of Sample: Number of Participants Recruited (time frame: 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05923229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.