Moving Mindfully for Freezing in Parkinsons

NCT05309083 | Completed Results DMC

• 1 other identifier: 202012021
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Freezing of Gait

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  14 weeks

Study Arms (1)

Mindfulness Based Walking Therapy (MBWT)

EXPERIMENTAL

Participants will participate in MBWT.

Behavioral: Mindfulness Based Walking Therapy (MBWT)

Interventions

Mindfulness Based Walking Therapy (MBWT) BEHAVIORAL

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.

Mindfulness Based Walking Therapy (MBWT)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine Program in Physical Therapy

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Kerri Rawson
• Organization: Washington University School of Medicine

rawson@wustl.edu

813-468-8900

Study Officials

• Gammon Earhart, PT, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Kerri Rawson, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: In Aim 2, participants will receive the mindfulness intervention as part of the open pilot.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 4, 2022
• Study Start: July 22, 2022
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2024-05

Locations

US (1)