TURN-IT FOG: Improving Turning and Freezing of Gait in People With PD
Purpose
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
Conditions
- Parkinson Disease
- Freezing of Gait Symptoms in Parkinson Disease
Eligibility
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dynamic balance exercise intervention group |
Six weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. |
|
|
Active Comparator Strength training exercise intervention group |
Six weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. |
|
Recruiting Locations
Tempe 5317058, Arizona 5551752 85281
Portland 5746545, Oregon 5744337 97239
More Details
- NCT ID
- NCT06815302
- Status
- Recruiting
- Sponsor
- Oregon Health and Science University