Parkinson Disease, Freezing of Gait Symptoms in Parkinson Disease
Conditions
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
Interventions
BEHAVIORALExperimental intervention
Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
BEHAVIORALActive intervention
Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil, United States
Contacts
Primary ContactGraham R Harker, MPH
Outcome results
None listed