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

NCT06815302 | Recruiting

• 1 other identifier: MJFF-024692
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Parkinson Disease; Freezing of Gait Symptoms in Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Time Spent in FOG during daily life

  From enrollment/randomization through intervention; 8 weeks

Study Arms (2)

Dynamic balance exercise intervention group

EXPERIMENTAL

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

Strength training exercise intervention group

ACTIVE COMPARATOR

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

Interventions

Experimental intervention BEHAVIORAL

Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

Dynamic balance exercise intervention group

Active intervention BEHAVIORAL

Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

Strength training exercise intervention group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (3)

Arizona State University

Tempe, Arizona, 85281, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

University of São Paulo, Bauru Campus

Bauru, São Paulo, 17012-230, Brazil

RECRUITING

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

Study Officials

• Martina Mancini, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graham R Harker, MPH

CONTACT

(503) 418-2601; harkerg@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data would be available 6 months after publication.
• Access Criteria: Data will be deposited on Zenodo https://zenodo.org/records/12548174

Locations

BR (1); US (2)