Augmented Reality Treadmill Training in Patients With Parkinson's Disease (Falls_in_PD)

Klinik Valens

Status: Enrolling

Conditions: Parkinson Disease; Fall

Treatments: Device: C-Mill augmented reality treadmill training

Study type: Interventional

Funder types: Other

Identifiers

NCT04108741

V1 19.09.2019

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 35 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups

treadmill training with augmented reality dual tasking

Experimental group

Treatment:

Device: C-Mill augmented reality treadmill training

treadmill training with random number generation dual tasking

Experimental group

Treatment:

Device: C-Mill augmented reality treadmill training

treadmill training

Active Comparator group

Treatment:

Device: C-Mill augmented reality treadmill training