Augmented Reality Treadmill Training in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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Gait disorder is a disabling symptom in Parkinson's disease (PD) affecting all patients during the course. Three methods of treadmill training (TT) will be compared to assess additional augmented reality (AR), or additional dual task (DT). AR TT, DT TT, and TT alone applied over 3 weeks at each day will be compared for their impact on falls, walking, freezing and attention for 3 months in a double blinded randomized controlled trial during regular neurorehabilitation.

Official Title
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Augmented Reality Treadmill Training in Patients With Parkinson's Disease: a Randomized Controlled Study

Conditions
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Parkinson Disease, Fall

Intervention / Treatment
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* Device: C-Mill augmented reality treadmill training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent as documented by signature Parkinson´s disease without dementia and hallucination at least one fall within the past 3 months or postural instability Gait disorder Hoehn and Yahr stages II-IV able to perform the treadmill therapy during a study Exclusion Criteria: Contraindications to treadmill therapy (e.g. hip fracture) Dementia as defined by an Montreal cognitive assessment (MOCA) < 20

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 99 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treadmill training with augmented reality dual tasking<br> | Device: C-Mill augmented reality treadmill training<br>* PD Patients will be randomized to treadmill training with augmented reality or to treadmill training with random number generation or to treadmill training for 3 weeks at 5 days a week for 30 minutes.<br>|
| Experimental: treadmill training with random number generation dual tasking<br> | Device: C-Mill augmented reality treadmill training<br>* PD Patients will be randomized to treadmill training with augmented reality or to treadmill training with random number generation or to treadmill training for 3 weeks at 5 days a week for 30 minutes.<br>|
| Active Comparator: treadmill training<br> | Device: C-Mill augmented reality treadmill training<br>* PD Patients will be randomized to treadmill training with augmented reality or to treadmill training with random number generation or to treadmill training for 3 weeks at 5 days a week for 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of falls | group difference of the difference in falls | 3 months before study to 3 months following the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes: | Freezing of Gait (FOG) Questionnaire | before and after the training period of 3 weeks | 
| Sensor based gait analyses | for one week | before and after the training period of 3 weeks and after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease