Parkinson DiseaseNCT05965661
A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease
A study testing virtual reality upper limb hand training in people with Parkinson Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- virtual reality upper limb hand training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Jul 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Manuela Pastore, PhD, 0412057220, manuela.pastore@luks.ch
About this study
Official title: A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease: a Randomized Pilot Study
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.
Read the detailed description
Patients with Parkinson's disease (PD) suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation offers virtual reality (VR). We explore the effects of a VR-based upper limb hand training compared to a VR control training, which is less specific for dexterity. Moreover, we examine the effetcs of the trainings on upper limb related ADL, and therefore the impact on QoL in patients with PD.
- Conditions
- Parkinson Disease
- Being tested
- virtual reality upper limb hand training, virtual reality control training
- 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
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality upper limb hand trainingOther
The PD patients randomized in the experimental group will receive virtual reality upper limb hand training.
virtual reality control trainingOther
The PD patients randomized in the control group will receive virtual reality control training.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality upper limb hand training | Other | The PD patients randomized in the experimental group will receive virtual reality upper limb hand training. Receives: 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. Receives: Other: virtual reality control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
hand dexterity
Nine Hole Peg test (9-HPT): The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD. seconds will be measured.
Measured: 4 weeks
grip strenght
The handheld JAMAR dynamometer measures the grip strength. kg will be measured.
Measured: 4 weeks
motor function
MDS-Sponsored Revision of the Unified Parkinson Disease Rating Scale (MDS-UPDRS III): It evaluates motor aspects of Parkinson's disease
Measured: 4 weeks
self-reported dexterity related problems in daily living
Dexterity Questionnaire 24 (DextQ-24): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD. score range 24-96, higher scores mean more dexterity problems.
Measured: 4 weeks
self-reported problems in quality of life
Parkinson's Disease Questionnaire (PDQ-39): This questionnaire is a standardized patient self-rated outcome measure (PROM) for evaluating QOL in PD. range 0-156, higher values mean more problems.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start19 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Vanbellingen, Prof, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965661
- Sponsor's protocol ID
- 2022-01545
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease: a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05965661
- Acronym / sponsor ID
- 2022-01545
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, virtual reality training, dexterity, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with Parkinson's disease (PD) suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation offers virtual reality (VR). We explore the effects of a VR-based upper limb hand training compared to a VR control training, which is less specific for dexterity. Moreover, we examine the effetcs of the trainings on upper limb related ADL, and therefore the impact on QoL in patients with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized pilot study
| Arm | Type | Receives |
|---|---|---|
| Virtual reality upper limb hand training | Other | Other: virtual reality upper limb hand trainingThe PD patients randomized in the experimental group will receive virtual reality upper limb hand training. |
| Virtual reality control training | Other | Other: virtual reality control trainingThe PD patients randomized in the control group will receive virtual reality control training. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality upper limb hand trainingThe 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 trainingThe PD patients randomized in the control group will receive virtual reality control training. | Other | Virtual reality control training |
Primary outcome
fine finger movements
Time frame: 4 weeks
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.
5 secondary outcomes
hand dexterity
Time frame: 4 weeks
grip strenght
Time frame: 4 weeks
motor function
Time frame: 4 weeks
self-reported dexterity related problems in daily living
Time frame: 4 weeks
self-reported problems in quality of life
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Vanbellingen, Prof principal investigator
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality upper limb hand training in people with Parkinson Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cornelia Cox, MSc (041 205 56 80, cornelia.cox@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fine finger movements (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.