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Not yet recruiting NCT06538909

Steps Against the Burden of Parkinson's Disease - StepuP

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 25 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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. To assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility; 3. To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD; 4. 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.

Interventions

  • Device VR
    Virtual reality that simulates obstacles on the road during walking

Primary outcome measures

  • motion capture [Time frame: 13 months]
  • describe brain activity by EEG cap [Time frame: 13 months]
  • describe muscles activity by EMG electrodes [Time frame: 13 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

  • Moderate or severe depression (BDI-II ≥18)
  • Orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06538909 · 0569-23-TLV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗