- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05340283
Parkinson's Disease in Home Rehabilitation Services
Clinical-epidemiological Characteristics of Patients With Parkinson's Disease Referred to a Home Rehabilitation Service
Introduction: Home rehabilitation is a form of care that is part of most health systems. Patients with Parkinson's disease can be referred to these Home Rehabilitation Services given the characteristics of the pathology they suffer.
Objective: know and analyse the clinical-epidemiological characteristics of patients with Parkinson's disease referred to a Home Rehabilitation Service belonging to health Area V of Gijón, Asturias, Spain.
Study Design: This project proposes an observational and retrospective study.
Study population: The subjects that will be part of this study will be men and women with Parkinson's disease who have been referred to the Home Rehabilitation Service from 2015 to 2021.
Study Overview
Detailed Description
Introduction:
Home-based rehabilitation is a care modality that is part of most healthcare systems. In most cases, patients are referred from hospitals, by the rehabilitation services themselves or by the specialist physicians who have treated them. Patients who may be candidates for home rehabilitation often have difficulties in accessing a hospital or outpatient centre independently, due to difficulty in walking and/or architectural barriers within or outside the home, so that in order to travel to outpatient centres, they need means of transport such as ambulances, which entails high costs. Patients with Parkinson's Disease can be referred to these Home Rehabilitation Services.
Objectives:
General:
Know and analyse the clinical-epidemiological characteristics of patients with Parkinson's Disease referred to a Home Rehabilitation Service belonging to the Health Area V of Gijón.
Specific:
Assess the distribution of patients by age group, sex, social conditions and degree of functional impairment.
Find out the time needed for recovery or completion of treatment, as well as the criteria for discharge.
Obtain information on the social assessment and architectural barriers of Parkinson's disease patients referred to a Home Rehabilitation Service.
Study design:
The present project proposes to carry out an observational, ex post facto, retrospective study.
The subjects who will be part of this study will be men and women with Parkinson's disease who have been referred to the Home Rehabilitation Service from 2015 to 2021. Available data from the entire population of patients with Parkinson's disease who meet the inclusion criteria will be analysed.
Limitations:
The limitations of the present study are that the patients will be analysed within a specific setting, such as a Home Rehabilitation Service, so it is possible that some results cannot be generalized.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men and women with Parkinson's disease
- Patients belonging to Health Area V of the Health System of the Principality of Asturias, Spain.
- Subjects who have been referred at some point to home rehabilitation.
Exclusion Criteria:
- Patients who have been discharged at the first medical visit.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational group
Patients with Parkinson's disease who were referred to a Home Rehabilitation Service in Gijón, Asturias region, Spain, during the years 2015 to 2021.
|
Patients received physiotherapy treatment at home for a certain period of time.
Data were collected on the assessments made at the beginning and at the end of the physiotherapy treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis:
Time Frame: Baseline
|
The specific diagnosis of Parkinsonian syndrome presented by each patient.
|
Baseline
|
Epidemiological characteristics
Time Frame: Baseline
|
Age, this variable will be measured in years.
Sex will be recorded as male and female.
Social assessment: the following data will be recorded: Place of residence: whether the patient lives alone at home, with his or her family or in a geriatric centre.
Existence or non-existence of a caregiver, if so, whether it is formal or informal.
Housing suitable for the patient's needs or not.
Finally, comorbidities: according to the Charlson comorbidity index, considering absence of comorbidity between 0 and 1 points, low comorbidity 2 points, high comorbidity between 3 and 5 points and severe comorbidity over 5 points.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barthel index
Time Frame: Baseline to end of treatment (up to 3 months)
|
Functional independence was measured by the Barthel Index.
It has a total score ranging from 0 to 100, where 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).
|
Baseline to end of treatment (up to 3 months)
|
Pain intensity
Time Frame: Baseline to end of treatment (up to 3 months)
|
Numerical visual analogue pain measurement scale.
The patient must assign a numerical value to the pain between two extreme points (0 no pain, to 10 the worst pain imaginable), the higher the score the greater the pain experienced.
|
Baseline to end of treatment (up to 3 months)
|
Gait assessment
Time Frame: Baseline to end of treatment (up to 3 months)
|
Gait ability measured according to Holden's Gait Classification (FAC).
This scale ranges from 0 (no gait) to 5 (independent gait including walking up and down stairs).
The higher the score, the better the gait performance.
|
Baseline to end of treatment (up to 3 months)
|
Reason for discharge
Time Frame: End of treatment (up to 3 months)
|
Can be the following options:
|
End of treatment (up to 3 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: María Cruz Sousa-Fraguas, University of Oviedo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 243-2021 Parkinson´s disease
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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