Augmented Reality Treadmill Training in Patients With Parkinson's Disease

NCT ID: NCT04108741

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Parkinson Disease Fall

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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treadmill training with augmented reality dual tasking

Group Type EXPERIMENTAL

C-Mill augmented reality treadmill training

Intervention Type DEVICE

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.

treadmill training with random number generation dual tasking

Group Type EXPERIMENTAL

C-Mill augmented reality treadmill training

Intervention Type DEVICE

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.

treadmill training

Group Type ACTIVE_COMPARATOR

C-Mill augmented reality treadmill training

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinik Valens

OTHER

Sponsor Role lead

Responsible Party

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Veit Mylius

Priniciple Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Veit Mylius, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Kliniken Valens

Locations

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Department of Neurology

Valens, Canton of St. Gallen, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Veit Mylius, Prof. Dr.

Role: CONTACT

0041813031406

Facility Contacts

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Veit Mylius, Prof. Dr.

Role: primary

Other Identifiers

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V1 19.09.2019

Identifier Type: -

Identifier Source: org_study_id

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