StrokeNCT03284580
Effectiveness of a Home-based Ergonomic Intervention Program in Caregivers of Chronic Post-stroke Patients
A study testing Ergonomic intervention and Postural plus kinesiotherapy intervention program in people with Stroke and Quality of Life, run by Universidad de Granada at 1 site in Spain.
Trial summary
The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Quality of Life
- What is being tested?
- Ergonomic intervention and Postural plus kinesiotherapy intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2017to 20 Aug 2017
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being caregivers of post-stroke patients
- Being over 18 years old
Who cannot join
- Being caregiver of patients with other neurological patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Home-based Ergonomic Intervention Program on Overall Quality of Life, Health Satisfaction, and Home Ergonomics in Caregivers of Chronic Post-stroke Patients: a Randomized Controlled Clinical Trial
The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients
Read the detailed description
Stroke is a neurological pathology that can cause functional problems and an impairment to perform activities of daily living at home.
For this reason, these patients need the support of a caregiver. Caregivers of post-stroke patients often have also problems with their quality of life because of the care that they must provide. These problems appear mainly during the support tasks in the activities performed at the patient's home.
The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients
- Conditions
- Stroke, Quality of Life
- Being tested
- Ergonomic intervention, Postural plus kinesiotherapy intervention program, Control or conservative intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic interventionOther
An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
Postural plus kinesiotherapy intervention programOther
Also called A postural plus kinesiotherapy intervention program, including excercises for caregivers
An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
Control or conservative interventionOther
A control or conservative intervention, including general information about stroke disease for the caregivers of these patients
| Study group | Role | What they receive |
|---|---|---|
| Ergonomic intervention group | Experimental | Ergonomic intervention program at home for caregivers Receives: Other: Ergonomic intervention |
| Postural + kinesiotherapy intervention group | Experimental | A postural + kinesiotherapy intervention program at home for caregivers Receives: Other: Postural plus kinesiotherapy intervention program |
| Control or conservative group | Other | A conservative intervention by general information for caregivers Receives: Other: Control or conservative intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from WhoQol-Bref at 8 weeks
This test measures quality of life
Measured: Eight weeks
Change from WhoQol-Bref at 16 weeks
This test measures quality of life
Measured: Sixteen weeks
Secondary outcomes (2)
Change from ergonomic evaluation of the domestic environment at 8 weeks
This measurement evaluates if domestic environment is ergonomic
Measured: Eight weeks
Change from ergonomic evaluation of the domestic environment at 16 weeks
This measurement evaluates if domestic environment is ergonomic
Measured: Sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start8 Jan 2017
- Primary completion9 Aug 2017
- Study completion20 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Manuel Pérez Mármol, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284580
- Sponsor's protocol ID
- Rehab in carers of post-stroke
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Araujo Freitas Moreira KL, Abalos-Medina GM, Villaverde-Gutierrez C, Gomes de Lucena NM, Belmont Correia de Oliveira A, Perez-Marmol JM. Effectiveness of two home ergonomic programs in reducing pain and enhancing quality of life in informal caregivers of post-stroke patients: A pilot randomized controlled clinical trial. Disabil Health J. 2018 Jul;11(3):471-477. doi: 10.1016/j.dhjo.2018.01.003. Epub 2018 Feb 13.
PubMed 29452985
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home-based Ergonomic Intervention Program on Overall Quality of Life, Health Satisfaction, and Home Ergonomics in Caregivers of Chronic Post-stroke Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03284580
- Acronym / sponsor ID
- Rehab in carers of post-stroke
- Conditions
- Stroke, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 8 Jan 2017 (actual)
- Primary completion
- 9 Aug 2017 (actual)
- Study completion
- 20 Aug 2017 (actual)
- First posted
- 15 Sep 2017 (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.
The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients
Detailed description
Stroke is a neurological pathology that can cause functional problems and an impairment to perform activities of daily living at home.
For this reason, these patients need the support of a caregiver. Caregivers of post-stroke patients often have also problems with their quality of life because of the care that they must provide. These problems appear mainly during the support tasks in the activities performed at the patient's home.
The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ergonomic intervention group | Experimental | Other: Ergonomic interventionErgonomic intervention program at home for caregivers |
| Postural + kinesiotherapy intervention group | Experimental | Other: Postural plus kinesiotherapy intervention programA postural + kinesiotherapy intervention program at home for caregivers |
| Control or conservative group | Other | Other: Control or conservative interventionA conservative intervention by general information for caregivers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being caregivers of post-stroke patients
- Being over 18 years old
Key exclusion criteria (1 listed)
- Being caregiver of patients with other neurological patients
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 |
|---|---|---|
| Ergonomic interventionAn ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home. | Other | Ergonomic intervention group |
| Postural plus kinesiotherapy intervention programAlso: A postural plus kinesiotherapy intervention program, including excercises for caregiversAn ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home. | Other | Postural + kinesiotherapy intervention group |
| Control or conservative interventionA control or conservative intervention, including general information about stroke disease for the caregivers of these patients | Other | Control or conservative group |
Primary outcome
Change from WhoQol-Bref at 8 weeks
Time frame: Eight weeks
This test measures quality of life
Change from WhoQol-Bref at 16 weeks
Time frame: Sixteen weeks
This test measures quality of life
2 secondary outcomes
Change from ergonomic evaluation of the domestic environment at 8 weeks
Time frame: Eight weeks
Change from ergonomic evaluation of the domestic environment at 16 weeks
Time frame: Sixteen weeks
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 15 Sep 2017.
- Derived from this study: PubMed 29452985de Araujo Freitas Moreira KL, Abalos-Medina GM, Villaverde-Gutierrez C, Gomes de Lucena NM, Belmont Correia de Oliveira A, Perez-Marmol JM. Effectiveness of two home ergonomic programs in reducing pain and enhancing quality of life in informal caregivers of post-stroke patients: A pilot randomized controlled clinical trial. Disabil Health J. 2018 Jul;11(3):471-477. doi: 10.1016/j.dhjo.2018.01.003. Epub 2018 Feb 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomic intervention and Postural plus kinesiotherapy intervention program in people with Stroke and Quality of Life, run by Universidad de Granada at 1 site in Spain.
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 2 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from WhoQol-Bref at 8 weeks (time frame: Eight weeks). 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?
On the ClinicalTrials.gov record for NCT03284580, which also lists 1 linked publication.
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 15 Sep 2017; AzTrials last refreshed its copy on 28 Oct 2026.