Steps Against the Burden of Parkinson's Disease - StepuP

NCT06538909 | Not Yet Recruiting

• 1 other identifier: 0569-23-TLV
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goals of our StepuP project are:

1. 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. 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. 3.To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD;
4. 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• motion capture

  Kinematic data will be collected using a Qualisys or Vicon motion capture system at a sampling frequency of 100 Hz.

  13 months

• describe brain activity by EEG cap

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

  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.

  13 months

Secondary Outcomes (15)

• clinical trial TUG

  13 months

• clinical trial walk test

  13 months

• clinical trial MiniBESTest

  13 months

• mGES questionnaire

  13 months

• FES-i questionnaire

  13 months

Study Arms (1)

PD with VR int.

EXPERIMENTAL

Parkinson's disease patients using Virtual reality intervention that include physical activity and cognitive

Device: VR

Interventions

VR DEVICE

Virtual reality that simulates obstacles on the road during walking

Also known as: Virtual Reality

PD with VR int.

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share