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NCT Number: NCT06815302

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

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Freezing of Gait Symptoms in Parkinson Disease Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of São Paulo, Bauru Campus, Bauru, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental intervention

Behavioral

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

Active intervention

Behavioral

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

Primary outcomes

  1. Patient- Perceived Freezing of Gait Severity

    Time frame: From enrollment/randomization through intervention; 8 weeks

    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)

  2. Clinician- Perceived Freezing of Gait Severity

    Time frame: From enrollment/randomization through intervention; 8 weeks

    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

  3. Sensors-based Freezing of gait severity

    Time frame: From enrollment/randomization through intervention; 8 weeks

    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.

Secondary outcomes

  1. Time Spent in FOG during daily life

    Time frame: From enrollment/randomization through intervention; 8 weeks

    % time spent FOG compared to walking during daily life calculated from wearable sensors

Study contacts

Contact information is provided by the study sponsor or research team.

Graham R Harker, MPH

CONTACT

[email protected]

(503) 418-2601

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 7, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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