Steps Against the Burden of Parkinson's Disease - StepuP (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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: VR

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD with VR int.; Parkinson's disease patients using Virtual reality intervention that include physical activity and cognitive	Device: VR; Virtual reality that simulates obstacles on the road during walking; Other Names: Virtual Reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical trial TUG	standard time-up-and-go test	13 months
clinical trial walk test	2-minute walk test	13 months
clinical trial MiniBESTest	balance and fall risk	13 months
mGES questionnaire	modified gait efficacy scale	13 months
FES-i questionnaire	Short falls efficacy scale international FES-i	13 months
FACIT-F questionnaire	fatigue	13 months
EQ-5D questionnaire	health-related quality of life	13 months
Frailty questionnaire	Frailty index for physical activity	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	13 months
MDS-UPDRS test	MDS-UPDRS	13 months
NFOGQ questionnaires	NFOGQ	13 months
aids questionnaires	Use of mobility aids	13 months
cognition questionnaires	MoCA and trail making test for cognition	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.	13 months
Fracture history questionnaire	Fracture history (number and type of fracture, twelve-month retrospective of T0)	13 months

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 0569-23-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No