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

NCT07105787 | Recruiting

• 1 other identifier: 6ef2e427b004
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 2

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.

Conditions

Parkinson Disease; Falls

Keywords

EEG; EMG; perturbation; daily-life gait

Outcome Measures

Primary Outcomes (3)

• Gait speed - T0

  Comfortable walking speed overground

  Baseline

• Gait speed - T1

  Comfortable walking speed overground

  After Intervention (2-12 weeks)

• Gait speed - T2

  Comfortable walking speed overground

  After Follow-up 12±2 weeks following T1 (20-32 weeks)

Secondary Outcomes (77)

• Fall events (occurrence and frequency) and fall related injuries - T0

  Baseline (T0)

• Fracture history - T0

  Baseline (T0)

• Medication - T0

  Baseline (T0)

• Medication - T1

  After Intervention (2-12 weeks)

• Medication - T2

  Follow-up 12±2 weeks following T1

Study Arms (2)

Experimental

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.

Other: SDTT + VR triggered adaptations

Control

ACTIVE COMPARATOR

Other: Speed-dependent treadmill training (SDTT)

Interventions

SDTT + VR triggered adaptations OTHER

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

Experimental

Speed-dependent treadmill training (SDTT) 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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PD according to the MDS Criteria
• Hoehn and Yahr stages I to III;
• Movement Disorder Society-sponsored version of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) gait sub-score of 1 or more
• Signed informed consent to participation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kiel: lead
• IRCCS Istituto delle Scienze Neurologiche di Bologna: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator

Study Sites (2)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Italy

RECRUITING

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: August 6, 2025
• Study Start: March 31, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-02

Locations

IT (1); IL (1)