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NCT Number: NCT06538909

Steps Against the Burden of Parkinson's Disease - StepuP

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.

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Key information

Conditions

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

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR

Device

Virtual reality that simulates obstacles on the road during walking

Other names: Virtual Reality

Primary outcomes

  1. 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.

  2. describe brain activity by EEG cap

    Time frame: 13 months

    EEG recordings will be made using a 64-channel or 128 channel EEG cap

  3. 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.

Secondary outcomes

  1. clinical trial TUG

    Time frame: 13 months

    standard time-up-and-go test

  2. clinical trial walk test

    Time frame: 13 months

    2-minute walk test

  3. clinical trial MiniBESTest

    Time frame: 13 months

    balance and fall risk

  4. mGES questionnaire

    Time frame: 13 months

    modified gait efficacy scale

  5. FES-i questionnaire

    Time frame: 13 months

    Short falls efficacy scale international FES-i

  6. FACIT-F questionnaire

    Time frame: 13 months

    fatigue

  7. EQ-5D questionnaire

    Time frame: 13 months

    health-related quality of life

  8. Frailty questionnaire

    Time frame: 13 months

    Frailty index for physical activity

  9. Fall questionnaires

    Time frame: 13 months

    Fall events (occurrence and frequency) and fall related injuries. (twelve-month retrospective during T0 and during the duration of the trail

  10. MDS-UPDRS test

    Time frame: 13 months

    MDS-UPDRS

  11. NFOGQ questionnaires

    Time frame: 13 months

    NFOGQ

  12. aids questionnaires

    Time frame: 13 months

    Use of mobility aids

  13. cognition questionnaires

    Time frame: 13 months

    MoCA and trail making test for cognition

  14. Demographics questionnaire ( descriptive measures)

    Time frame: 13 months

    General descriptive measures : Year of birth, gender, height, weight, shoe size, education, employment, living arrangement, smoking history and alcohol consumption.

  15. Fracture history questionnaire

    Time frame: 13 months

    Fracture history (number and type of fracture, twelve-month retrospective of T0)

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Acronym: StepuP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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