- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108741
Augmented Reality Treadmill Training in Patients With Parkinson's Disease (Falls_in_PD)
March 7, 2023 updated by: Veit Mylius, Klinik Valens
Augmented Reality Treadmill Training in Patients With Parkinson's Disease: a Randomized Controlled Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Veit Mylius, Prof. Dr.
- Phone Number: 0041813031406
- Email: veit.mylius@kliniken-valens.ch
Study Locations
-
-
Saint Gallen
-
Valens, Saint Gallen, Switzerland, 7317
- Recruiting
- Department of Neurology
-
Contact:
- Veit Mylius, Prof. Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treadmill training with augmented reality dual tasking
|
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.
|
Experimental: treadmill training with random number generation dual tasking
|
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.
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of falls
Time Frame: 3 months before study to 3 months following the study
|
group difference of the difference in falls
|
3 months before study to 3 months following the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary outcomes:
Time Frame: before and after the training period of 3 weeks
|
Freezing of Gait (FOG) Questionnaire
|
before and after the training period of 3 weeks
|
Sensor based gait analyses
Time Frame: before and after the training period of 3 weeks and after 3 months
|
for one week
|
before and after the training period of 3 weeks and after 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Veit Mylius, Prof. Dr., Department of Neurology, Kliniken Valens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2020
Primary Completion (Anticipated)
November 1, 2025
Study Completion (Anticipated)
November 1, 2025
Study Registration Dates
First Submitted
September 20, 2019
First Submitted That Met QC Criteria
September 27, 2019
First Posted (Actual)
September 30, 2019
Study Record Updates
Last Update Posted (Estimate)
March 9, 2023
Last Update Submitted That Met QC Criteria
March 7, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V1 19.09.2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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