Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease (INTENSO)

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT06695286
• Lead Sponsor: Università Politecnica delle Marche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2024-08-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-09
• Study First Submitted QC: 2024-11-16
• Last Update Submitted: 2024-11-16
• Study First Posted: 2024-11-19
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Non-motor Symptoms	before treatment, immediately after treatment, and six months following the end of the treatment	The changes in non-motor symptoms mesaured by the Unified Parkinson's Disease Rating Scale part I ( UPDRS part I; score range 0-52; higher scores mean a worse outcome)

Secondary Outcome Measures

Name	Time	Method
Changes in Parkinson's Disease related disability	before treatment, immediately after treatment, and six months following the end of the treatment	The Parkinson's Disease related disability measured by the the Unified Parkinson's Disease Rating Scale part II (UPDRS Part II; score range 0-52; higher scores mean a worse outcome)
Changes in motor symptoms severity	before treatment, immediately after treatment, and six months following the end of the treatment	Changes in motor symptoms severity measured by the Unified Parkinson's Disease Rating Scale part III (UPDRS Part III; score range 0-128; higher scores mean a worse outcome)
Changes in the severity of the Freezing of Gait	before treatment, immediately after treatment, and six months following the end of the treatment	The changes in Severity of the Freezing of Gait mesaured by the Freezing of Gait Questionnaire (FOGQ; score range 0-24; higher scores mean a worse outcome)

Trial Locations

Locations (1)

Department of Experimental and Clinical Medicine, Politecnica delle Marche University,; 🇮🇹 Ancona, AN, Italy