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Augmented Reality Treadmill Training in Patients With Parkinson's Disease (Falls_in_PD)

Primary Purpose

Parkinson Disease, Fall

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
C-Mill augmented reality treadmill training
Sponsored by
Klinik Valens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease

Eligibility Criteria

35 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

treadmill training with augmented reality dual tasking

treadmill training with random number generation dual tasking

treadmill training

Arm Description

Outcomes

Primary Outcome Measures

Frequency of falls
group difference of the difference in falls

Secondary Outcome Measures

Secondary outcomes:
Freezing of Gait (FOG) Questionnaire
Sensor based gait analyses
for one week

Full Information

First Posted
September 20, 2019
Last Updated
March 7, 2023
Sponsor
Klinik Valens
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1. Study Identification

Unique Protocol Identification Number
NCT04108741
Brief Title
Augmented Reality Treadmill Training in Patients With Parkinson's Disease
Acronym
Falls_in_PD
Official Title
Augmented Reality Treadmill Training in Patients With Parkinson's Disease: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinik Valens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Fall
Keywords
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treadmill training with augmented reality dual tasking
Arm Type
Experimental
Arm Title
treadmill training with random number generation dual tasking
Arm Type
Experimental
Arm Title
treadmill training
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
C-Mill augmented reality treadmill training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of falls
Description
group difference of the difference in falls
Time Frame
3 months before study to 3 months following the study
Secondary Outcome Measure Information:
Title
Secondary outcomes:
Description
Freezing of Gait (FOG) Questionnaire
Time Frame
before and after the training period of 3 weeks
Title
Sensor based gait analyses
Description
for one week
Time Frame
before and after the training period of 3 weeks and after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veit Mylius, Prof. Dr.
Phone
0041813031406
Email
veit.mylius@kliniken-valens.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veit Mylius, Prof. Dr.
Organizational Affiliation
Department of Neurology, Kliniken Valens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology
City
Valens
State/Province
Saint Gallen
ZIP/Postal Code
7317
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veit Mylius, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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Augmented Reality Treadmill Training in Patients With Parkinson's Disease

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