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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04108741
Other study ID # V1 19.09.2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date November 2025

Study information

Verified date March 2023
Source Klinik Valens
Contact Veit Mylius, Prof. Dr.
Phone 0041813031406
Email veit.mylius@kliniken-valens.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 35 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
C-Mill augmented reality treadmill training
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.

Locations

Country Name City State
Switzerland Department of Neurology Valens Saint Gallen

Sponsors (1)

Lead Sponsor Collaborator
Klinik Valens

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of falls group difference of the difference in falls 3 months before study to 3 months following the study
Secondary Secondary outcomes: Freezing of Gait (FOG) Questionnaire before and after the training period of 3 weeks
Secondary Sensor based gait analyses for one week before and after the training period of 3 weeks and after 3 months
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