TURN-IT FOG: Improving Turning and Freezing of Gait in People With PD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorOregon Health and Science University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental intervention
BehavioralSpecific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
Active intervention
BehavioralSpecific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Dynamic balance exercise intervention groupExperimental treatment 1 intervention
Group B: Strength training exercise intervention groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient- Perceived Freezing of Gait Severity
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)
Time frame
From enrollment/randomization through intervention; 8 weeks2
Clinician- Perceived Freezing of Gait Severity
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
Time frame
From enrollment/randomization through intervention; 8 weeks3
Sensors-based Freezing of gait severity
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.
Time frame
From enrollment/randomization through intervention; 8 weeksSecondary outcomes
1
Time Spent in FOG during daily life
% time spent FOG compared to walking during daily life calculated from wearable sensors
Time frame
From enrollment/randomization through intervention; 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
Michael J. Fox Foundation for Parkinson's Research
Collaborator
Source ClinicalTrials.gov