UnknownNot Applicable

Effect of a Progressive Treadmill Training Protocol for Parkinson's Disease

Italy60 participantsStarted 2022-07-06

Plain-language summary

The primary objective of this single-center, no-profit, longitudinal interventional randomized controlled, single-blind trial is to compare the effects of 2 different treadmill training treatments using C-Mill: the experimental one, endowed with augmented virtual reality (AVR) applications, versus the conventional one, the standard treadmill training in PD patients with gait and or balance disturbances. The main questions the study aims to answer are 1) Is the experimental treatment more effective than the conventional one? 2) Is it possible to identify predictive and indicative biomarkers of an outcome measure of rehabilitation using extracellular vesicles (cEVs) assessed by Raman spectroscopy? Participants will be randomized into two groups: the experimental group that will receive the experimental intervention, and the control group that will receive the conventional intervention. Both groups will train three times per week for 8 weeks, the first session starting from 25 minutes (25'). The experimental and the conventional treatments are planned to be progressive and will be individualized to the participant's level of performance. Clinical, neuropsychological, and instrumental variables will be collected at baseline (T0), at the end of the treatment (T1), and 3 months after the end of treatment (T2). At 6 months after the end of treatment (T3), a phone interview will be performed. Both within-group and between-group analyses will be conducted. Biosamples will be collected at baseline (T0) and at the end of treatment (T1).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Mean change in gait and balance parameters assessed by the Performance Oriented Mobility Assessment - POMA scale (intra-group and between-group comparisons)

Timeframe: T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment)

Mean change in motors parameters assessed by the Modified Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III (intra-group and between-group comparisons)

Timeframe: T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment)

Trial details

NCT IDNCT05902065

SponsorUniversity of Florence

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

Contact for this trial

Francesca Cecchi, MD

00393388627184 francesca.cecchi@unifi.it

View on ClinicalTrials.gov More Parkinson Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean change in gait and balance parameters assessed by the Performance Oriented Mobility Assessment - POMA scale (intra-group and between-group comparisons)

Timeframe: T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment)

Mean change in motors parameters assessed by the Modified Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III (intra-group and between-group comparisons)

Timeframe: T0 (baseline); T1 (end of the treatment - 8 weeks); T2 (3 months after the end of treatment)