Moving Mindfully for Freezing in Parkinsons

NCT ID: NCT05309083

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-22
• Study Completion Date: 2023-03-28

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness Based Walking Therapy (MBWT)

Participants will participate in MBWT.

Group Type: EXPERIMENTAL

Mindfulness Based Walking Therapy (MBWT)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Gammon M Earhart

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gammon Earhart, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Kerri Rawson, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine Program in Physical Therapy

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

202012021

Identifier Type: -

Identifier Source: org_study_id