Parkinson DiseaseFalls_in_PDNCT04108741
Augmented Reality Treadmill Training in Patients With Parkinson's Disease
A study testing C-Mill augmented reality treadmill training in people with Parkinson Disease and Fall, run by Klinik Valens at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 99 years
- Conditions the study is for
- Parkinson Disease, Fall
- What is being tested?
- C-Mill augmented reality treadmill training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2020to 10 Jun 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 35 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications to treadmill therapy (e.g. hip fracture)
- Dementia as defined by an Montreal cognitive assessment (MOCA) < 20
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurology
Valens, Canton of St. Gallen, 7317
About this study
Official title: Augmented Reality Treadmill Training in Patients With Parkinson's Disease: a Randomized Controlled Study
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
- Being tested
- C-Mill augmented reality treadmill training
- Keywords
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Mill augmented reality treadmill trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| treadmill training with augmented reality dual tasking | Experimental | Not described Receives: Device: C-Mill augmented reality treadmill training |
| treadmill training with random number generation dual tasking | Experimental | Not described Receives: Device: C-Mill augmented reality treadmill training |
| treadmill training | Active comparator | Not described Receives: Device: C-Mill augmented reality treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of falls
group difference of the difference in falls
Measured: 3 months before study to 3 months following the study
Secondary outcomes (2)
Secondary outcomes:
Freezing of Gait (FOG) Questionnaire
Measured: before and after the training period of 3 weeks
Sensor based gait analyses
for one week
Measured: before and after the training period of 3 weeks and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start15 Sep 2020
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Why it stopped: recruitment difficulties
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veit Mylius, Klinik Valens
- Investigators
- Veit Mylius, Prof. Dr., Principal investigator, Department of Neurology, Kliniken Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108741
- Sponsor's protocol ID
- V1 19.09.2019
- Acronym
- Falls_in_PD
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2019
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality Treadmill Training in Patients With Parkinson's Disease: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04108741
- Acronym / sponsor ID
- Falls_in_PD / V1 19.09.2019
- Conditions
- Parkinson Disease, Fall
- Keywords
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 30 Sep 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindications to treadmill therapy (e.g. hip fracture)
- Dementia as defined by an Montreal cognitive assessment (MOCA) < 20
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 |
|---|---|---|
| C-Mill augmented reality treadmill trainingPD 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. | Device | treadmill training, treadmill training with augmented reality dual tasking, treadmill training with random number generation dual tasking |
Primary outcome
Frequency of falls
Time frame: 3 months before study to 3 months following the study
group difference of the difference in falls
2 secondary outcomes
Secondary outcomes:
Time frame: before and after the training period of 3 weeks
Sensor based gait analyses
Time frame: before and after the training period of 3 weeks and after 3 months
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- 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.
Veit Mylius, Prof. Dr. principal investigator
Department of Neurology, Kliniken Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Mill augmented reality treadmill training in people with Parkinson Disease and Fall, run by Klinik Valens 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 10 Aug 2026. 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?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of falls (time frame: 3 months before study to 3 months following the study). 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 10 Aug 2026.