Trial Outcomes & Findings for Moving Mindfully for Freezing of Gait (NCT NCT05923229)

Last Updated: 2025-06-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

14 weeks

Results posted on

2025-06-17

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Mindfulness-Based Walking Therapy (MBWT) Participants will receive the MBWT intervention.	Freezing of Gait (FOG) Education Participants will receive educational materials about FOG and track their usual care.
Overall Study STARTED	12	12
Overall Study COMPLETED	7	11
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Mindfulness-Based Walking Therapy (MBWT) Participants will receive the MBWT intervention.	Freezing of Gait (FOG) Education Participants will receive educational materials about FOG and track their usual care.
Overall Study Withdrawal by Subject	3	0
Overall Study Health related	2	1

Baseline Characteristics

Moving Mindfully for Freezing of Gait

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness-Based Walking Therapy (MBWT) n=12 Participants Participants will receive the MBWT intervention.	Freezing of Gait (FOG) Education n=12 Participants Participants will receive educational materials about FOG and track their usual care.	Total n=24 Participants Total of all reporting groups
Age, Continuous	69.17 years of age STANDARD_DEVIATION 8.45 • n=5 Participants	69.83 years of age STANDARD_DEVIATION 7.33 • n=7 Participants	69.50 years of age STANDARD_DEVIATION 7.75 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
New Freezing of Gait Questionnaire (N-FOG)	18.08 units on a scale STANDARD_DEVIATION 4.87 • n=5 Participants	18.58 units on a scale STANDARD_DEVIATION 4.81 • n=7 Participants	18.33 units on a scale STANDARD_DEVIATION 4.74 • n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Outcome measures

Outcome measures
Measure	Mindfulness-Based Walking Therapy (MBWT) n=12 Participants Participants will receive the MBWT intervention.	Freezing of Gait (FOG) Education n=12 Participants Participants will receive educational materials about FOG and track their usual care.
Recruitment of Sample: Number of Participants Recruited	12 Participants	12 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Walking Therapy (MBWT) n=14 sessions Participants will receive the MBWT intervention.	Freezing of Gait (FOG) Education Participants will receive educational materials about FOG and track their usual care.
Attendance of Participants: Average Number of Participants at Each Session	88.46 percentage of participants Interval 71.43 to 100.0	—

PRIMARY outcome

Timeframe: 14 weeks

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

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.

Outcome measures

Outcome measures
Measure	Mindfulness-Based Walking Therapy (MBWT) n=12 Participants Participants will receive the MBWT intervention.	Freezing of Gait (FOG) Education Participants will receive educational materials about FOG and track their usual care.
Retention of Participants: Number of Participants Who Attended 80% of the Sessions or More	6 Participants	—

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Mindfulness-Based Walking Therapy (MBWT) n=6 Participants Participants will receive the MBWT intervention.	Freezing of Gait (FOG) Education Participants will receive educational materials about FOG and track their usual care.
Adherence: Average Percentage of Hours Participants Practiced Mindfulness at Home	89.54 percentage of home assignment hours Interval 53.0 to 247.9	—

Adverse Events

Mindfulness-Based Walking Therapy (MBWT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Freezing of Gait (FOG) Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kerri Rawson

Washington University School of Medicine

Phone: 314-273-1053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place