Parkinson DiseaseFreezing of Gait Symptoms in Parkinson Disease
Investigational drug(s) / intervention(s)
Experimental interventionActive intervention
Experimental intervention: Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
Active intervention: Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
Study 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
Sex
ALL
Min age
50 Years
Max age
80 Years
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
Primary outcome measure(s)
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; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse)
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 the clinician; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse
Sensors-based Freezing of gait severity — From enrollment/randomization through intervention; 8 weeks Freezing of Gait Index calculated during a 360 degrees turning in place from wearable sensors; continuous scale, with a higher positive score meaning a greater level of freezing of gait.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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