Parkinson DiseaseNCT05340283
Parkinson's Disease in Home Rehabilitation Services
An observational study of Parkinson Disease, run by University of Oviedo.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- physiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 13 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Parkinson's disease
Who may be able to join
- 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.
Who cannot join
- Patients who have been discharged at the first medical visit.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- physiotherapy
- Keywords
- Parkinson disease, Parkinsonian disorders, Home care services, Home care agencies, Rehabilitation, Physical therapy modalities
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyProcedure or surgery
Also called Physiotherapy treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis:
The specific diagnosis of Parkinsonian syndrome presented by each patient.
Measured: Baseline
Epidemiological characteristics
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.
Measured: Baseline
Secondary outcomes (4)
Barthel index
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).
Measured: Baseline to end of treatment (up to 3 months)
Pain intensity
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.
Measured: Baseline to end of treatment (up to 3 months)
Gait assessment
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.
Measured: Baseline to end of treatment (up to 3 months)
Reason for discharge
Can be the following options:
- The value of the Barthel index reached at the end of treatment.
- Chronicity.
- Referral to outpatient rehabilitation.
- Change of residence.
- Voluntary discharge.
- Hospital admission.
- Worsening without hospital admission.
- Exitus.
Measured: End of treatment (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jan 2015
- Primary completion1 Apr 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Cruz Sousa Fraguas, University of Oviedo
- Investigators
- María Cruz Sousa-Fraguas, Principal investigator, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340283
- Sponsor's protocol ID
- 243-2021 Parkinson´s disease
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-epidemiological Characteristics of Patients With Parkinson's Disease Referred to a Home Rehabilitation Service
- ClinicalTrials.gov ID
- NCT05340283
- Acronym / sponsor ID
- 243-2021 Parkinson´s disease
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Parkinsonian disorders, Home care services, Home care agencies, Rehabilitation, Physical therapy modalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Procedure: physiotherapyPatients with Parkinson's disease who were referred to a Home Rehabilitation Service in Gijón, Asturias region, Spain, during the years 2015 to 2021. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Parkinson's disease
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who have been discharged at the first medical visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapyAlso: Physiotherapy treatmentPatients 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. | Procedure or surgery | Observational group |
Primary outcome
Diagnosis:
Time frame: Baseline
The specific diagnosis of Parkinsonian syndrome presented by each patient.
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.
4 secondary outcomes
Barthel index
Time frame: Baseline to end of treatment (up to 3 months)
Pain intensity
Time frame: Baseline to end of treatment (up to 3 months)
Gait assessment
Time frame: Baseline to end of treatment (up to 3 months)
Reason for discharge
Time frame: End of treatment (up to 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Cruz Sousa-Fraguas principal investigator
University of Oviedo
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Oviedo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis: (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.