Augmented Reality Treadmill Training in Patients With Parkinson's Disease

NCT04108741 | Unknown

• 1 other identifier: V1 19.09.2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Fall

Keywords

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Frequency of falls

  group difference of the difference in falls

  3 months before study to 3 months following the study

Secondary Outcomes (2)

• Secondary outcomes:

  before and after the training period of 3 weeks

• Sensor based gait analyses

  before and after the training period of 3 weeks and after 3 months

Study Arms (3)

treadmill training with augmented reality dual tasking

EXPERIMENTAL

Device: C-Mill augmented reality treadmill training

treadmill training with random number generation dual tasking

EXPERIMENTAL

Device: C-Mill augmented reality treadmill training

treadmill training

ACTIVE COMPARATOR

Device: C-Mill augmented reality treadmill training

Interventions

C-Mill augmented reality treadmill training 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; treadmill training with augmented reality dual tasking; treadmill training with random number generation dual tasking

Eligibility Criteria

• Age: 35 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications to treadmill therapy (e.g. hip fracture)
• Dementia as defined by an Montreal cognitive assessment (MOCA) \< 20

Sponsors & Collaborators

• Klinik Valens: lead

Study Sites (1)

Department of Neurology

Valens, Canton of St. Gallen, 7317, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Veit Mylius, Prof. Dr.

  Department of Neurology, Kliniken Valens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veit Mylius, Prof. Dr.

CONTACT

0041813031406; veit.mylius@kliniken-valens.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priniciple Investigator

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 30, 2019
• Study Start: September 15, 2020
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)