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

Klinik Valens1 site in 1 country50 target enrollmentSeptember 15, 2020

ConditionsParkinson Disease Fall

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Klinik Valens
Enrollment: 50
Locations: 1
Primary Endpoint: Frequency of falls
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 15, 2020

End Date

November 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Klinik Valens

Responsible Party

Principal Investigator

Veit Mylius

Priniciple Investigator

Klinik Valens

Eligibility Criteria

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

Outcomes

Primary Outcomes

Frequency of falls

Time Frame: 3 months before study to 3 months following the study

group difference of the difference in falls

Secondary Outcomes

Secondary outcomes:(before and after the training period of 3 weeks)
Sensor based gait analyses(before and after the training period of 3 weeks and after 3 months)