Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease

Study Overview
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Brief Summary
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A split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. However, subsequent work raises questions as to whether treadmill improvements following repeated SBT training generalize to overground situations in the long term. Therefore, in this study, the investigators will perform a four-week SBT intervention with added practice of everyday turning scenarios (SBT+CP) or placebo exercise (SBT+PL), and study its effects on FOG in both the laboratory and at home.

Official Title
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Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related Freezing of Gait in Parkinson's Disease

Conditions
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Parkinson Disease, Freezing of Gait, Split-belt Treadmill

Intervention / Treatment
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* Behavioral: Split-belt treadmill training
* Behavioral: Complex task practice
* Behavioral: Static balance exercise


Participation Criteria
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Eligibility Criteria
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Be between 40 - 90 years of age Have a diagnosis of Parkinson's disease Be able to walk for 10 min without an aid Be able to follow and understand the oral instructions of the investigator Have a disease stage of I to IV (while ON-medication) Have had no change in your Parkinson's medication in the past month (or to your deep brain stimulator if applicable) and also no planned changes in medication over the next 4 months Have at least about 1 freezing episode per day (based on the New Freezing of Gait Questionnaire: N-FOG) Not participating in another clinical trial Have no acute joint disease Not have any other condition that affects your walking pattern or prevents you from completing all study tasks Have not undergone major surgery or hospitalization in the last 3 months No substance abuse No depressive disorder or other apathetic disorder that precludes daily exercise

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised single-blind parallel-group study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBT+CP<br>Split-belt training + complex task practice | Behavioral: Split-belt treadmill training<br>* Split-belt walking with various speed ratios between the two legs, applied with random-block practice<br>Behavioral: Complex task practice<br>* Overground gait flexibility training with added cognitive tasks<br>|
| Active Comparator: SBT+PL<br>Split-belt training + static exercise | Behavioral: Split-belt treadmill training<br>* Split-belt walking with various speed ratios between the two legs, applied with random-block practice<br>Behavioral: Static balance exercise<br>* Mindfulness and breathing combined with static balance exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Time Frozen during turning in place | Percentage Time Frozen scored from video of rapid alternating full turns in place. Based on earlier work showing immediate effects of SBT training on FOG during this task. | up to 8 weeks post intervention | 
| Time to complete Timed Up and Go (TUG) | Overall time to complete the Timed Up and Go task. The training is expected to improve multiple transitions between straight walking and turning and should be reflected in the overall task time. | up to 8 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Time Frozen over all FOG-provoking tasks | Percentage Time Frozen scored from videos of Turning in place,TUG, Hotspot door and Hotspot personalized. | up to 8 weeks post intervention | 
| Percentage Time Frozen over 1-week free-living monitoring | Percentage Time Frozen estimated from machine learning algorithm using free-living sensor data captured over 1 week. | up to 8 weeks post intervention |