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

NCT ID: NCT06815302

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-02
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Active intervention

Intervention Type: BEHAVIORAL

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

Interventions

Experimental intervention

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

Intervention Type: BEHAVIORAL

Active intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Martina Mancini

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martina Mancini, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Arizona State University

Tempe, Arizona, United States

Site Status: RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status: RECRUITING

University of São Paulo, Bauru Campus

Bauru, São Paulo, Brazil

Site Status: RECRUITING

Countries

United States; Brazil

Central Contacts

Graham R Harker, MPH

Role: CONTACT

harkerg@ohsu.edu

(503) 418-2601

Other Identifiers

MJFF-024692

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MJFF-024692

Identifier Type: -

Identifier Source: org_study_id