Clinical trial NCT06815302: TURN-IT FOG: Improving Turning and Freezing of Gait in People With PD
Official title: TURN-IT FOG: A Novel Intervention to Improve Turning in People With PD and Freezing of Gait
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Freezing of Gait Symptoms in Parkinson&#39;s Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2025-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* a) 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; b) reporting FOG in the New Freezing of Gait questionnaire (N-FOGQ); b) Hoehn \& Yahr stages II-IV; c) ages 50-80 years old, d) cognitive ability sufficient to participate in testing procedures and exercise classes, and e) be willing and able to participate in exercise intervention 3x/week for 6 weeks.

Exclusion Criteria:

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

Primary outcomes:
measure: Patient- Perceived Freezing of Gait Severity
timeFrame: From enrollment/randomization through intervention; 8 weeks
measure: Clinician- Perceived Freezing of Gait Severity
timeFrame: From enrollment/randomization through intervention; 8 weeks
measure: Sensors-based Freezing of gait severity
timeFrame: From enrollment/randomization through intervention; 8 weeks
Secondary outcomes:
measure: Time Spent in FOG during daily life
timeFrame: From enrollment/randomization through intervention; 8 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Bauru
country: Brazil
facility: University of São Paulo, Bauru Campus
state: Sao Paulo
Study officials:
affiliation: Oregon Health and Science University
name: Martina Mancini, PhD
role: PRINCIPAL_INVESTIGATOR
References: