Steps Against the Burden of Parkinson's Disease - TelAviv/Bologna

NCT ID: NCT07105787

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-04-30

Brief Summary

Parkinson's disease (PD) affects over 10 million worldwide, causing unstable gait and falls in 70% of patients despite medication. This leads to confidence loss, isolation, fractures, and hospitalizations. Treadmill training, augmented by mechanical/virtual-reality triggers, has proven effective in enhancing gait and reducing falls. However, underlying treadmill training mechanisms are unclear. To personalize training, we'll explore how PD patients benefit and transfer effects to daily life.

This trial is part of three parallel randomized controlled trials within the Steps Against the Burden of Parkinson's Disease (CT-IDs: 6ef2e427b002, 6ef2e427b003, 6ef2e427b004) project, which will perform a pooled analysis across all sites in addition to individual RCT analyses. Each trial adheres to a shared core protocol while allowing for adaptations in the perturbation protocol, ensuring that data can be combined. Importantly, mechanistic findings and outcomes from this specific RCT will be reported independently, but also as part of a pooled analysis.

In this trials, PD patients will undergo treadmill training with and without adaptaions (perturbations). 12 sessions of treadmill training will be provided, with pre/post assessments and a follow-up with pre/post assessments and a follow-up at 8 to 12 weeks after the post assessment. For post treadmill training a phone app will be offered as a home-based speed dependent walk training intervention. This intervention is an App based training for gait adaptability and allows users to set their own training time and pace. It delivers a rhythmic metronomic beat for three different walking speeds, designed to trigger movement and encourage better walking patterns.. Gait improvements are expected, driven by sensorimotor integration improving balance control. Biomechanical data analysis will reveal enhanced foot placement control. Neurophysiological changes will be studied through EEG and EMG, aiming to find improved gait stability with reduced EEG beta power and increased EEG-EMG coherence.

Gait improvement in the lab might not correlate with daily-life results. Gait self-efficacy could influence transfer, prompting investigation into mechanistic associations with mobility outcomes. Remote digital tools will assess week-long mobility outcomes, employing machine learning to comprehend why some improve both in lab and life, while others don't. This will uncover mechanisms translating treatment effects into real-world outcomes, aiding personalized intervention development.

Detailed Description

i. Rationale The rationale of this trial is that speed dependent treadmill training (SDTT) improves gait through improved sensorimotor integration, with changes in cortical activity as neural correlates. Additional benefits of treadmill training can be seen if perturbation or adaptations are added. This is based on the idea, that in addition to the sensorimotor integration the reactive balance in trained as well18. Furthermore, it hypothesizes that treadmill training and its effects on gait quality will improve gait self-efficacy, which mediates and/or modifies transfer of training effects to improved daily-life gait.

ii. Objectives

Thus, the objectives of our StepuP project are:

1. To understand the kinematic and neural mechanisms that underlie improvements in gait due to treadmill training with and without mechanically and VR-triggered gait adaptations in people with PD;

2. To assess to what extent improvements in gait due to treadmill training, as measured in the lab, transfer to improvements in daily life mobility;

3. To understand the mechanisms that underpin transfer from improvements in gait to improvements of mobility in daily life in people with PD;

4. To understand for whom treadmill training improves lab-based gait characteristics and for whom it does not, and understand for whom treadmill training improves mobility in daily life and for whom it does not.

Attaining these objectives will provide a better understanding of the successes and failures of treadmill training to improve gait stability and prevent falls in people with PD at an individual level, which in the medium term will allow targeted delivery of such interventions and in the long term will allow personalization of such interventions to improve outcomes for all.

iii. Endpoints Concerning the endpoints, this trial examines the effect of treadmill training with and without perturbations on gait performance, and neural correlates in people with PD. The primary endpoint is (change in) gait speed, secondary endpoints are divided into three groups (clinical, kinematic and neurophysiological). Clinical measures are used to assess the effect of training on disease symptoms. Kinematic measures are changes from baseline to follow-up, all under controlled conditions (treadmill), and provide insight into gait performance and quality. Neurophysiological measures aim to understand the neural control mechanisms underlying the training effects. On an exploratory level, the study aims to assess the training effects on daily-life gait by using wearable devices and assess gait self-efficacy using previously validated questionnaires.

Conditions

Parkinson Disease; Falls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Experimental

The experimental group will engage in 12-sessions of SDTT with additional virtual reality triggered adaptations, contrasting with the control group undergoing regular SDTT.

Group Type: EXPERIMENTAL

SDTT + VR triggered adaptations

Intervention Type: OTHER

The SDTT+ VR triggered adaptations program will trigger reactive gait adaptations by presenting obstacles in VR.

Control

Group Type: ACTIVE_COMPARATOR

Speed-dependent treadmill training (SDTT)

Intervention Type: OTHER

This training methodology focuses on adjusting the treadmill's speed according to the individual's walking pace, creating a more dynamic and adaptive exercise environment. SDTT is designed to mimic real-world walking conditions and challenges, promoting neuromuscular coordination, balance, and overall mobility. By tailoring the treadmill speed to match the user's gait, SDTT encourages the development of natural and efficient walking patterns. This training technique has shown promise in various clinical settings, aiding individuals with gait impairments caused by neurological conditions, musculoskeletal disorders, or post-injury rehabilitation. Its adaptability allows for progressive adjustments as a person's walking abilities improve, making it a versatile tool for optimizing gait mechanics and functional mobility. To ensure continued progress and integration into daily life, home-based walking training, supported by a phone application, will be included between T1 and T2.

Interventions

SDTT + VR triggered adaptations

The SDTT+ VR triggered adaptations program will trigger reactive gait adaptations by presenting obstacles in VR.

Intervention Type: OTHER

Speed-dependent treadmill training (SDTT)

This training methodology focuses on adjusting the treadmill's speed according to the individual's walking pace, creating a more dynamic and adaptive exercise environment. SDTT is designed to mimic real-world walking conditions and challenges, promoting neuromuscular coordination, balance, and overall mobility. By tailoring the treadmill speed to match the user's gait, SDTT encourages the development of natural and efficient walking patterns. This training technique has shown promise in various clinical settings, aiding individuals with gait impairments caused by neurological conditions, musculoskeletal disorders, or post-injury rehabilitation. Its adaptability allows for progressive adjustments as a person's walking abilities improve, making it a versatile tool for optimizing gait mechanics and functional mobility. To ensure continued progress and integration into daily life, home-based walking training, supported by a phone application, will be included between T1 and T2.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of PD according to the MDS Criteria

2. Hoehn and Yahr stages I to III;

3. Movement Disorder Society-sponsored version of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) gait sub-score of 1 or more

4. Signed informed consent to participation

Exclusion Criteria

• Any known general health condition likely to interfere with or to pose a contraindication to non-medically supervised physical exercise.
• Moderate or severe depression (BDI-II ≥18)
• Cognitive impairment which may preclude the possibility to provide a fully informed consent to enrolment.
• Linguistic comprehension capacity less than 75% in ordinary conversation
• Severe psychiatric comorbidity which may interfere with compliance to the study protocol History of or current status of substance dependency
• Unable to walk less than 1 floor
• Thoracic pain in the last 4 weeks
• Currently enrolled in other interventional studies
• Implanted Deep Brain Stimulation device

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Istituto delle Scienze Neurologiche di Bologna

OTHER

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: collaborator

University of Kiel

OTHER

Sponsor Role: lead

Responsible Party

Walter Maetzler

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Israel; Italy

Facility Contacts

Jeffrey Hausdorff

Role: primary

jhausdor@tlvmc.gov.il

+972-3-6973081

Fabio Laporta

Role: primary

fabio.laporta3@unibo.it

+39 051 208 0310

Other Identifiers

6ef2e427b004

Identifier Type: -

Identifier Source: org_study_id