Augmented Reality Treadmill Training in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

— Falls_in_PD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04108741
• Other study ID #: V1 19.09.2019
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fall
• Parkinson Disease

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