Augmented Reality Treadmill Training in Patients With Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Fall; Parkinson Disease
• Interventions: Device: C-Mill augmented reality treadmill training

• Registration Number: NCT04108741
• Lead Sponsor: Klinik Valens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Study Start: 2020-09-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treadmill training	C-Mill augmented reality treadmill training	-
treadmill training with augmented reality dual tasking	C-Mill augmented reality treadmill training	-
treadmill training with random number generation dual tasking	C-Mill augmented reality treadmill training	-

Primary Outcome Measures

Name	Time	Method
Frequency of falls	3 months before study to 3 months following the study	group difference of the difference in falls

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes:	before and after the training period of 3 weeks	Freezing of Gait (FOG) Questionnaire
Sensor based gait analyses	before and after the training period of 3 weeks and after 3 months	for one week

Trial Locations

Locations (1)

Department of Neurology; 🇨🇭 Valens, Saint Gallen, Switzerland