Parkinson DiseaseMMR34NCT05309083

Moving Mindfully for Freezing in Parkinsons

A study testing Mindfulness Based Walking Therapy (MBWT) in people with Parkinson Disease and Freezing of Gait, 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

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Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Parkinson Disease, Freezing of Gait
What is being tested?: Mindfulness Based Walking Therapy (MBWT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 22 Jul 2022to 28 Mar 2023
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 55 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 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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine Program in Physical Therapy
St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the 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. Aim 3 is under NCT05923229.

Conditions: Parkinson Disease, Freezing of Gait
Being tested: Mindfulness Based Walking Therapy (MBWT)
Keywords: Mindfulness
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 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.

Study groups in NCT05309083
Study group	Role	What they receive
Mindfulness Based Walking Therapy (MBWT)	Experimental	Participants will participate in MBWT. Receives: Behavioral: Mindfulness Based Walking Therapy (MBWT)

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 12 participants.
Measured: 14 weeks
Attendance of Participants: Average Percentage of Participants at Each Session
The investigators will count the number of participants at each session and report the average percentage of participants that attended each 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.
Measured: 14 weeks
Retention of Participants: Average Percentage of Sessions Each Participant Completes
The investigators will count the number of sessions each participant attends and report the number of classes each participant attended on average to determine if the feasibility objective of retention is met. The investigators benchmark for retention is defined as 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 defined as participants completing 70% of daily home assignment hours.
Measured: 14 weeks

Timeline

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

22 Jul 202228 Mar 2023

First posted4 Apr 2022
Study start22 Jul 2022
Primary completion28 Mar 2023
Study completion28 Mar 2023

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: In Aim 2, participants will receive the mindfulness intervention as part of the open pilot.
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05309083
Sponsor's protocol ID: 202012021
Acronym: MMR34
Status last verified: May 2024
First submitted: 16 Mar 2022
Last updated: 14 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: 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

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2024. 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
ClinicalTrials.gov ID: NCT05309083
Acronym / sponsor ID: MMR34 / 202012021
Conditions: Parkinson Disease, Freezing of Gait
Keywords: Mindfulness
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 22 Jul 2022 (actual)
Primary completion: 28 Mar 2023 (actual)
Study completion: 28 Mar 2023 (actual)
First posted: 4 Apr 2022 (actual)
Results: Posted 14 Jun 2024

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: In Aim 2, participants will receive the mindfulness intervention as part of the open pilot.

Arm	Type	Receives
Mindfulness Based Walking Therapy (MBWT)	Experimental	Behavioral: Mindfulness Based Walking Therapy (MBWT)Participants will participate in MBWT.

Who may qualify

Ages: 55 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 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;

Key exclusion criteria (6 listed)

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

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 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.	Behavioural	Mindfulness Based Walking Therapy (MBWT)

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 12 participants.
Attendance of Participants: Average Percentage of Participants at Each Session
Time frame: 14 weeks
The investigators will count the number of participants at each session and report the average percentage of participants that attended each 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.
Retention of Participants: Average Percentage of Sessions Each Participant Completes
Time frame: 14 weeks
The investigators will count the number of sessions each participant attends and report the number of classes each participant attended on average 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: Average Percentage of Hours Participants Practiced Mindfulness at Home
Time frame: 14 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 defined as participants completing 70% of daily home assignment hours.

Results and safety

Results posted to the registry on 14 Jun 2024, 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)	9	7

Primary outcome: Recruitment of Sample: Number of Participants Recruited

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

Measure	MBWT n = 12
Value	12

Population analysed: Twelve participants were recruited and signed a consent form. Three participants did not pass in-person screening resulting in nine participants who started the intervention.

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

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

Measure	MBWT n = 9
Value	79.82 (55.56 to 100)

Population analysed: 7 participants completed the 14 week program, 2 participants withdrew after class 5

Primary outcome: Retention of Participants: Average Percentage of Sessions Each Participant Completes

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

Measure	MBWT n = 9
Value	78.25 (60 to 100)

Population analysed: 7 participants who completed the 14 week program and 2 participants who withdrew after class 5

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

Time frame: 14 weeks. Mean (Full Range). Unit: percentage of home assignment hours

Measure	MBWT n = 5
Value	147.84 (23 to 325)

Population analysed: Only five participants regularly reported home assignment hours.

Adverse events

Time frame: Adverse Events were collected during baseline evaluations (1-4 weeks prior), the 14 week intervention, post evaluations (1-4 weeks post intervention) and follow-up evaluations (12-16 weeks after post); on average 38 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MBWT	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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, PT, 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?

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

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 6 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 14 Jun 2024. 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. 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 14 Jun 2024). 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 NCT05309083.

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 14 Jun 2024.