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

Study Locations

  • Switzerland
    • 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
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.
Experimental: treadmill training with random number generation dual tasking
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.
Active Comparator: treadmill training
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.

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

Klinik Valens

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.

Clinical Trials on Parkinson Disease

Clinical Trials on C-Mill augmented reality treadmill training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe