TURN-IT FOG: Improving Turning and Freezing of Gait in People With PD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental intervention, Active intervention.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Freezing of Gait Symptoms in Parkinson Disease. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
TURN-IT FOG: A Novel Intervention to Improve Turning in People With PD and Freezing of Gait
Overview
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
Interventions
- Behavioral Experimental intervention
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.
Primary outcome measures
- Patient- Perceived Freezing of Gait Severity [Time frame: From enrollment/randomization through intervention; 8 weeks]
- Clinician- Perceived Freezing of Gait Severity [Time frame: From enrollment/randomization through intervention; 8 weeks]
- Sensors-based Freezing of gait severity [Time frame: From enrollment/randomization through intervention; 8 weeks]
Secondary outcome measures (1)
- Time Spent in FOG during daily life [Time frame: From enrollment/randomization through intervention; 8 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Arizona State University — Tempe
- Oregon Health and Science University — Portland
Brazil · 1 center
- University of São Paulo, Bauru Campus — Bauru
Identifiers
NCT: NCT06815302 · MJFF-024692 · MJFF-024692