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

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Parkinson Disease; Freezing of Gait Symptoms in Parkinson Disease

Treatments: Behavioral: Experimental intervention; Behavioral: Active intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06815302

MJFF-024692 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Dynamic balance exercise intervention group

Experimental group

Description:

Six weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

Treatment:

Behavioral: Experimental intervention

Strength training exercise intervention group

Active Comparator group

Description:

Six weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

Treatment:

Behavioral: Active intervention