Progressive treadmill training for improving balance in Parkinson's disease
Biomarkers of Rehabilitation Outcome in Patients With Parkinson's Disease: Effect of a Customized Protocol on Treadmill Training With and Without Augmented Virtual Reality Application, a Randomized Controlled Trial
This study is testing if treadmill training with virtual reality can help improve balance better than regular treadmill training for people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florence Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT05902065 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two different treadmill training protocols for patients with Parkinson's disease who experience gait and balance disturbances. One group will undergo augmented virtual reality (AVR) treadmill training, while the other will receive conventional treadmill training. Participants will be randomized into these two groups and will train three times a week for eight weeks. The study also seeks to identify potential biomarkers for rehabilitation outcomes using advanced techniques. The trial is being conducted at the University of Florence and associated rehabilitation centers.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of Parkinson's disease, experiencing gait disturbances and postural instability.
Not a fit: Patients with concurrent conditions affecting gait, significant cognitive impairment, or uncontrolled psychiatric disorders 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 reducing fall risk.
How similar studies have performed: Previous studies have shown promise in using augmented reality for rehabilitation, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease according to the diagnostic (POSTUMA criteria) * Hoehn and Yahr Stage II-III * Age\>18 years * One fall in the past 3 months/presence of postural instability /gait disturbance * Able to walk for at least 5 minutes without assistance * Stable drug therapy by at least 1 month * Willingness to participate in the study, ability to understand and willingness to sign informed consent Exclusion Criteria: * Other pathology concurrent with gait disturbance (symptomatic arthritis involving hip/knee/ankle, stroke outcomes, severe polyneuropathy) * Cognitive impairment capable of interfering with rehabilitation procedures, estimated as a score less than 18.58 at the Montreal Cognitive Assessment (MoCA), row score corrected according to Aiello et al, 2022 * Hallucinations * Psychiatric disorder not controlled by current drug therapy * Alcohol/drug use * Uncompensated visual/auditory deficit that limits enjoyment of the cues provided by the AVR * Communication deficit from any cause that impairs understanding of the task and the objectives of the intervention * Recurrent episodes of severe orthostatic hypotension * Severe cardiovascular diseases * Patient undergoing other experimental protocol (patients regularly undergoing physical activity or sport will not be excluded)
Where this trial is running
Florence
- IRCCS Fondazione Don Gnocchi Firenze — Florence, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Cecchi, MD
- Email: francesca.cecchi@unifi.it
- Phone: 00393388627184
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.