TURN-IT FOG: Improving Turning and Freezing of Gait in People With PD

TURN-IT FOG: A Novel Intervention to Improve Turning in People With PD and Freezing of Gait

The goals of this clinical trial are to 1) learn how two different rehabilitation interventions for PD can reduce Freezing of Gait (FOG) in people with Parkinson's disease, as assessed by patients, clinicians, and wearable sensors, and 2) to explore whether two different rehabilitation intervention can reduce FOG and improve daily life mobility in people with FOG sufficiently to justify a clinical trial.

Participants will:

• Be randomly assigned to one of two intervention groups (turning-focused agility exercise or strength-based exercise)
• Have one-on-one training sessions three times per week for 6 weeks
• Perform in-lab assessments before beginning and after completing the study intervention
• Use wearable mobility sensors during daily life to measure their walking and balance

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Freezing of Gait Symptoms in Parkinson Disease
• Intervention / Treatment: Behavioral: Experimental intervention; Behavioral: Active intervention

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Graham R Harker, MPH; Phone Number: (503) 418-2601; Email: harkerg@ohsu.edu

Study Locations

• Brazil
  • Sao Paulo
    • Bauru, Sao Paulo, Brazil, 17012-230
      • Recruiting
      • University of São Paulo, Bauru Campus
• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • Recruiting
      • Arizona State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
• reporting FOG in the New Freezing of Gait questionnaire (N-FOGQ)
• Hoehn & Yahr stages II-IV
• ages 50-80 years old
• cognitive ability sufficient to participate in testing procedures and exercise classes
• be willing and able to participate in exercise intervention 3x/week for 6 weeks

Exclusion Criteria:

• Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and turning (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease)
• medical condition or medications that precludes moderate-intensity exercise
• Montreal Cognitive Assessment (MoCA) ≤21 or inability to follow directions
• excessive use of alcohol or recreational drugs
• recent change in medication
• inability to stand and walk for 2 minutes without an assistive device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic balance exercise intervention group; Six weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.	Behavioral: Experimental intervention; Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
Active Comparator: Strength training exercise intervention group; Six weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.	Behavioral: Active intervention; Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient- Perceived Freezing of Gait Severity	Change in freezing of gait severity with the intervention (scored in likert scale by the patient; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse)	From enrollment/randomization through intervention; 8 weeks
Clinician- Perceived Freezing of Gait Severity	Change in freezing of gait severity with the intervention (scored in likert scale by the clinician; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse	From enrollment/randomization through intervention; 8 weeks
Sensors-based Freezing of gait severity	Freezing of Gait Index calculated during a 360 degrees turning in place from wearable sensors; continuous scale, with a higher positive score meaning a greater level of freezing of gait.	From enrollment/randomization through intervention; 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Spent in FOG during daily life	% time spent FOG compared to walking during daily life calculated from wearable sensors	From enrollment/randomization through intervention; 8 weeks

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Michael J. Fox Foundation for Parkinson's Research
• Investigators: Principal Investigator: Martina Mancini, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: MJFF-024692 (Other Grant/Funding Number: Michael J. Fox Foundation for Parkinson's Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data related to study outcomes measures will be publicly shared
• IPD Sharing Time Frame: Data would be available 6 months after publication.
• IPD Sharing Access Criteria: Data will be deposited on Zenodo https://zenodo.org/records/12548174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No