Parkinson DiseaseStepuPNCT06538909
Steps Against the Burden of Parkinson's Disease - StepuP
A study testing VR in people with Parkinson Disease, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The goals of our StepuP project are: 1. To understand the kinematic and neural mechanisms underlying walking improvements due to treadmill training with and without VR-enabled gait adaptations in people with PD; 2. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to 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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Specific criteria for Parkinson's disease - PD
- Diagnosis of Parkinson's disease according to the MDS World Movement Disorders Society criteria Disease severity H\&Y I-III
- Score section 3.10 (ability to walk) MDS-UPDRS 3.10 ≥ 1
- MoCA cognitive assessment > 15
- Stable cardiovascular condition, ability to perform aerobic activity at low to moderate intensity
- Without orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher.
Who cannot join
- Moderate or severe depression (BDI-II ≥18)
- Orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher
About this study
The goals of our StepuP project are:
- To understand the kinematic and neural mechanisms underlying walking improvements due to treadmill training with and without VR-enabled gait adaptations in people with PD;
- To assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility;
- To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD;
- To understand for whom treadmill training improves walking characteristics in the laboratory and for whom it does not, and to understand for whom treadmill training improves mobility in daily life and for whom it does not.
- Conditions
- Parkinson Disease
- Being tested
- VR
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRDevice
Also called Virtual Reality
Virtual reality that simulates obstacles on the road during walking
| Study group | Role | What they receive |
|---|---|---|
| PD with VR int. | Experimental | Parkinson's disease patients using Virtual reality intervention that include physical activity and cognitive Receives: Device: VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
motion capture
Kinematic data will be collected using a Qualisys or Vicon motion capture system at a sampling frequency of 100 Hz.
Measured: 13 months
describe brain activity by EEG cap
EEG recordings will be made using a 64-channel or 128 channel EEG cap
Measured: 13 months
describe muscles activity by EMG electrodes
Bipolar EMG electrodes will be placed on the leg muscles. EMG data will be recorded at a sample frequency available for each system around 2000 Hz.
Measured: 13 months
Secondary outcomes (15)
clinical trial TUG
standard time-up-and-go test
Measured: 13 months
clinical trial walk test
2-minute walk test
Measured: 13 months
clinical trial MiniBESTest
balance and fall risk
Measured: 13 months
mGES questionnaire
modified gait efficacy scale
Measured: 13 months
FES-i questionnaire
Short falls efficacy scale international FES-i
Measured: 13 months
FACIT-F questionnaire
fatigue
Measured: 13 months
EQ-5D questionnaire
health-related quality of life
Measured: 13 months
Frailty questionnaire
Frailty index for physical activity
Measured: 13 months
Fall questionnaires
Fall events (occurrence and frequency) and fall related injuries. (twelve-month retrospective during T0 and during the duration of the trail
Measured: 13 months
MDS-UPDRS test
MDS-UPDRS
Measured: 13 months
NFOGQ questionnaires
NFOGQ
Measured: 13 months
aids questionnaires
Use of mobility aids
Measured: 13 months
cognition questionnaires
MoCA and trail making test for cognition
Measured: 13 months
Demographics questionnaire ( descriptive measures)
General descriptive measures : Year of birth, gender, height, weight, shoe size, education, employment, living arrangement, smoking history and alcohol consumption.
Measured: 13 months
Fracture history questionnaire
Fracture history (number and type of fracture, twelve-month retrospective of T0)
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538909
- Sponsor's protocol ID
- 0569-23-TLV
- Acronym
- StepuP
- Status last verified
- Aug 2024
- First submitted
- 3 Jul 2024
- Last updated
- 6 Aug 2024
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps Against the Burden of Parkinson's Disease - StepuP
- ClinicalTrials.gov ID
- NCT06538909
- Acronym / sponsor ID
- StepuP / 0569-23-TLV
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Aug 2024 (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.
The goals of our StepuP project are:
- To understand the kinematic and neural mechanisms underlying walking improvements due to treadmill training with and without VR-enabled gait adaptations in people with PD;
- To assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility;
- To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD;
- To understand for whom treadmill training improves walking characteristics in the laboratory and for whom it does not, and to understand for whom treadmill training improves mobility in daily life and for whom it does not.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD with VR int. | Experimental | Device: VRParkinson's disease patients using Virtual reality intervention that include physical activity and cognitive |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Specific criteria for Parkinson's disease - PD
- Diagnosis of Parkinson's disease according to the MDS World Movement Disorders Society criteria Disease severity H\&Y I-III
- Score section 3.10 (ability to walk) MDS-UPDRS 3.10 ≥ 1
- MoCA cognitive assessment > 15
- Stable cardiovascular condition, ability to perform aerobic activity at low to moderate intensity
Key exclusion criteria (2 listed)
- Moderate or severe depression (BDI-II ≥18)
- Orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher
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 |
|---|---|---|
| VRAlso: Virtual RealityVirtual reality that simulates obstacles on the road during walking | Device | PD with VR int. |
Primary outcome
motion capture
Time frame: 13 months
Kinematic data will be collected using a Qualisys or Vicon motion capture system at a sampling frequency of 100 Hz.
describe brain activity by EEG cap
Time frame: 13 months
EEG recordings will be made using a 64-channel or 128 channel EEG cap
describe muscles activity by EMG electrodes
Time frame: 13 months
Bipolar EMG electrodes will be placed on the leg muscles. EMG data will be recorded at a sample frequency available for each system around 2000 Hz.
15 secondary outcomes
clinical trial TUG
Time frame: 13 months
clinical trial walk test
Time frame: 13 months
clinical trial MiniBESTest
Time frame: 13 months
mGES questionnaire
Time frame: 13 months
FES-i questionnaire
Time frame: 13 months
FACIT-F questionnaire
Time frame: 13 months
EQ-5D questionnaire
Time frame: 13 months
Frailty questionnaire
Time frame: 13 months
Fall questionnaires
Time frame: 13 months
MDS-UPDRS test
Time frame: 13 months
NFOGQ questionnaires
Time frame: 13 months
aids questionnaires
Time frame: 13 months
cognition questionnaires
Time frame: 13 months
Demographics questionnaire ( descriptive measures)
Time frame: 13 months
Fracture history questionnaire
Time frame: 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VR in people with Parkinson Disease, run by Tel-Aviv Sourasky Medical Center.
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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
motion capture (time frame: 13 months). The study lists 3 primary outcomes in all. 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 6 Aug 2024.