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Completed

NCT Number: NCT06695286

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Experimental and Clinical Medicine, Politecnica delle Marche University,

Ancona, AN, 60126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal rehabilitation training at high intensity

Other

In High Intensive Training patients received 1800 minutes of training globally.

In our practice, a single outpatient session varies from 60 to 90 minutes, the number of sessions per cycle from 10 to 20, and the frequency from 2 days a week to 5 days a week.

Irrespective of total course intensity, each session comprises at least 15 minutes of aerobic training (over ground or treadmill) and 10 minutes of flexibility and strengthening exercise.

No less than 10 minutes of balance training, 10 minutes of overground training in dual tasks, and 15 minutes of occupational therapy are additionally delivered. The duration of the single training components in each session may increase according to the patients' functioning profiles, requesting a more intensive practice of gait, balance or trunk alignment or a focused training of arm dexterity or basic ADL.

Multimodal rehabilitation training at low intensity

Other

In Low Intensive Training patients received less than 900 minutes of training globally.

In our practice, a single outpatient session varies from 60 to 90 minutes, the number of sessions per cycle from 10 to 20, and the frequency from 2 days a week to 5 days a week. Irrespective of total course intensity, each session comprises at least 15 minutes of aerobic training (over ground or treadmill) and 10 minutes of flexibility and strengthening exercise. No less than 10 minutes of balance training, 10 minutes of overground training in dual tasks, and 15 minutes of occupational therapy are additionally delivered. The duration of the single training components in each session may increase according to the patients' functioning profiles, requesting a more intensive practice of gait, balance or trunk alignment or a focused training of arm dexterity or basic ADL.

Primary outcomes

  1. Changes in Non-motor Symptoms

    Time frame: before treatment, immediately after treatment, and six months following the end of the treatment

    The changes in non-motor symptoms mesaured by the Non Motor Symptoms Scale ( NMSS; score range: 0-360; higher scores mean a worse outcome)

  2. Changes in Non-motor Symptoms

    Time frame: 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 outcomes

  1. Changes in Parkinson's Disease related disability

    Time frame: 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)

  2. Changes in motor symptoms severity

    Time frame: 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)

  3. Changes in the severity of the Freezing of Gait

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Registry information

Official study title

Impact of Intensive Outpatient Rehabilitation on Non-Motor Patient-Reported Outcomes in Parkinson's Disease: The INTENSO Study

Acronym: INTENSO

Important dates

Study start
2014
Primary completion
2019
Study completion
2024
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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