Steps Against the Burden of Parkinson's Disease - StepuP

NCT ID: NCT06538909

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PD with VR int.

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

Group Type: EXPERIMENTAL

VR

Intervention Type: DEVICE

Virtual reality that simulates obstacles on the road during walking

Interventions

VR

Virtual reality that simulates obstacles on the road during walking

Intervention Type: DEVICE

Other Intervention Names

Virtual Reality

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0569-23-TLV

Identifier Type: -

Identifier Source: org_study_id