Clinical trial NCT06695286: Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease (INTENSO)
Official title: Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease: The INTENSO Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson&#39;s Disease
rehabilitation
non-motor symptoms
multimodal
exercise
intensity
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is characterized by people with Parkinson's Disease consecutively referred to the outpatient rehabilitation facility of a Center for Diagnosis and Treatment of Movement Disorders, based in a university hospital in Italy.

Brief summary: This historical cohort study aims to evaluate the impact of different intensity rehabilitation protocols on the short and medium-term severity of non-motor symptoms in patients with Parkinson's Disease. One of the principal strengths of this study is that it is a real-life study, so it has a high external validity necessary to test the clinical effectiveness of these two types of training, which could have significant practical implications for rehabilitation in Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* adults diagnosed with Idiopathic PD, Hoehn \& Yahr stage ≥ 1 \< 5, consecutive referral to the rehabilitation facility between 1 January 2014 and 31 December 2019 to receive outpatient physiotherapy treatment for the management of motor disability, specifically targeting gait, balance, or posture disorders;
* completion of the course of rehabilitation treatment;
* availability of Non-Motor Symptom Scale and Unified Parkinson's Disease Rating Scale, recorded before and after treatment and 6 plus or minus 1 months later

Exclusion Criteria:

* diagnosis of any primary or secondary parkinsonism rather than PD
* symptom onset since less than three years
* any concomitant neurological disease (e.g. polyneuropathy, stroke, etc)
* any other chronically disabling disease (e.g. severe heart, liver or kidney failure, cancer, psychiatric disorders, limb amputation, severe musculoskeletal or neuropathic pain)
* changes in antiparkinsonian drug therapy during the whole study period
* exposure to a course of physiotherapy during the 6 months preceding the study

Primary outcomes:
measure: Changes in Non-motor Symptoms
timeFrame: before treatment, immediately after treatment, and six months following the end of the treatment
measure: Changes in Non-motor Symptoms
timeFrame: before treatment, immediately after treatment, and six months following the end of the treatment
Secondary outcomes:
measure: Changes in Parkinson's Disease related disability
timeFrame: before treatment, immediately after treatment, and six months following the end of the treatment
measure: Changes in motor symptoms severity
timeFrame: before treatment, immediately after treatment, and six months following the end of the treatment
measure: Changes in the severity of the Freezing of Gait
timeFrame: before treatment, immediately after treatment, and six months following the end of the treatment
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Department of Experimental and Clinical Medicine, Politecnica delle Marche University,
state: AN
Study officials:
affiliation: Università Politecnica delle Marche
name: Marianna Capecci, MD
role: PRINCIPAL_INVESTIGATOR
References: