Comparing rehabilitation methods for Parkinson's disease with gait issues

Multiparametric Biomarkers to Predict the Response to Different Protocols of Motor-cognitive Rehabilitation in Parkinson's Disease Subjects With Postural Instability and Gait Disorders

This study is testing two different rehabilitation methods to see which one helps people with Parkinson's disease who have trouble walking and balancing feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 45 Years to 85 Years
• Sex: All
• Sponsor: IRCCS San Raffaele (Academic / other)
• Locations: 2 sites (Milan and 1 other locations)
• Trial ID: NCT05799690 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of two different rehabilitation protocols on patients with Parkinson's disease who experience postural instability and gait disorders. Fifty participants will be randomly assigned to either a dual-task training group that incorporates action observation training and motor imagery or a dual-task group that uses landscape videos. The training will occur three times a week for six weeks, with assessments of clinical features, neuroimaging, and blood-based biomarkers conducted before and after the intervention, as well as at follow-up points. The goal is to determine which rehabilitation approach is more effective in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 45 to 85 with idiopathic Parkinson's disease and postural instability and gait disorders.

Not a fit: Patients with significant tremors, dementia, or other major health issues that affect cognition or mobility may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved rehabilitation strategies for patients with Parkinson's disease, enhancing their mobility and quality of life.

How similar studies have performed: Previous studies have shown promise in using dual-task training for improving gait and balance in Parkinson's disease, suggesting that this approach may be effective.

Eligibility criteria

Inclusion criteria for PD patients:

* 45 years ≤ age ≤ 85 years;
* Idiopathic PD according to the Movement Disorders Society (MDS) diagnostic criteria
* Hoehn \& Yahr (H\&Y) score \<= 4
* PIGD phenotype
* Stable dopaminergic medication for at least 4 weeks and without any changes during the observation period (28 weeks)
* No dementia according to Litvan's criteria and Mini-Mental Status Examination score (MMSE) \>= 24
* No significant tremor/involuntary movements that could determine artifacts during the MRI acquisition
* Oral and written informed consent to study participation

Inclusion criteria for healthy controls:

* sex-matched and age-matched (age range: mean age of PD years ± 15 years);
* oral and written informed consent to study participation

Exclusion criteria:

* Medical conditions or substance abuse that could interfere with cognition;
* Any major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability;
* Contraindications to undergoing MRI examination;
* Brain damage at routine MRI, including lacunae and extensive cerebrovascular disorders;
* Denied oral and written informed consent to study participation.

Where this trial is running

Milan and 1 other locations

• IRCCS San Raffaele — Milan, Italy (Recruiting)
• Neurology Unit, Azienda Ospedaliera Universitaria Integrata di Verona — Verona, Italy (Not_yet_recruiting)

Study contacts

• Study coordinator: Elisabetta Sarasso, MSc, PT

Conditions Parkinson Disease; Gait; Rehabilitation; Biomarkers; Magnetic resonance imaging