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

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease; Freezing of Gait Symptoms in Parkinson's Disease

• Registration Number: NCT06815302
• Lead Sponsor: Oregon Health and Science University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Study Start: 2025-03-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient- Perceived Freezing of Gait Severity	From enrollment/randomization through intervention; 8 weeks	Change in freezing of gait severity with the intervention (scored in likert scale by the patient)
Clinician- Perceived Freezing of Gait Severity	From enrollment/randomization through intervention; 8 weeks	Change in freezing of gait severity with the intervention (scored in likert scale by assessor)
Sensors-based Freezing of gait severity	From enrollment/randomization through intervention; 8 weeks	Freezing Index calculated during a 360 degrees turning in place from wearable sensors

Secondary Outcome Measures

Name	Time	Method
Time Spent in FOG during daily life	From enrollment/randomization through intervention; 8 weeks	% time spent FOG compared to walking during daily life calculated from wearable sensors

Trial Locations

Locations (3)

Arizona State University; 🇺🇸 Tempe, Arizona, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of São Paulo, Bauru Campus; 🇧🇷 Bauru, Sao Paulo, Brazil