A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease

NCT05965661 | Unknown DMC

• 1 other identifier: 2022-01545
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

We investigate the impact of a 4-week virtual reality-based upper limb training in Parkinson's disease. The benefits on dexterity of this training program will be evaluated. For these purposes, a randomised, two arm, single assessor blind, parallel design with a monocentric, study setup will be performed.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; virtual reality training; dexterity; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

• fine finger movements

  Coin rotation task (CRT): The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD. The seconds for 20 halfturns will be measured.

  4 weeks

Secondary Outcomes (5)

• hand dexterity

  4 weeks

• grip strenght

  4 weeks

• motor function

  4 weeks

• self-reported dexterity related problems in daily living

  4 weeks

• self-reported problems in quality of life

  4 weeks

Study Arms (2)

Virtual reality upper limb hand training

OTHER

The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.

Other: virtual reality upper limb hand training

Virtual reality control training

OTHER

The PD patients randomized in the control group will receive virtual reality control training.

Other: virtual reality control training

Interventions

virtual reality upper limb hand training OTHER

The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.

Virtual reality upper limb hand training

virtual reality control training OTHER

The PD patients randomized in the control group will receive virtual reality control training.

Virtual reality control training

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed PD, according to UK Brain bank Criteria
• Hoehn \& Yahr Stadium I to IV
• Age 40 to 99 years
• written and signed informed consent
• self-reported dexterous difficulties

You may not qualify if:

• MoCA \<21/30
• psychiatric disease
• participation on other interventional trials
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
• severe visual impairment

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Synucleinopathies

Study Officials

• Tim Vanbellingen, Prof

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cornelia Cox, MSc

CONTACT

041 205 56 80; cornelia.cox@luks.ch

Manuela Pastore, PhD

CONTACT

041 205 72 20; manuela.pastore@luks.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: VR upper limb hand training or VR control training
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized pilot study

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 28, 2023
• Study Start: July 19, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)