StrokeNCT03665220
Effects of Two Home Ergonomics Programmes in Post-stroke Patients
A study testing Ergonomic adjustments, Kinesiotherapy plus ergonomic adjustments and Healthcare education in people with Stroke and Quality of Life, run by Universidad de Granada at 1 site in Spain.
Trial summary
The main objective of the clinical trial is to evaluate the effectiveness of two home ergonomics programmes, by reference to a control group, on functional capacity and quality of life in post-stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Quality of Life
- What is being tested?
- Ergonomic adjustments, Kinesiotherapy plus ergonomic adjustments and Healthcare education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2017to 15 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke diagnosed 6-24 months previously
- aged over 18 years
- ability to speak and understand Portuguese.
Who cannot join
- severe cognitive deficit
- severe aphasia
- other associated neurological disease
- musculoskeletal pathology
- drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Two Home Ergonomics Programmes on Post-stroke Patients' Quality of Life and Functional Capacity: a Randomised Controlled Clinical Trial
The main objective of the clinical trial is to evaluate the effectiveness of two home ergonomics programmes, by reference to a control group, on functional capacity and quality of life in post-stroke patients.
Read the detailed description
For post-stroke patients, rehabilitation must address different aspects. When the resulting condition has become established, treatment should take the form of a mixed intervention model, incorporating preventive, rehabilitational and compensatory or adaptive approaches, aimed at enhancing the patient's performance within the environment. Physiotherapy and occupational therapy are key disciplines in the composition of multi- and inter-disciplinary teams for the care of stroke patients. In this clinical trial we evaluate the effectiveness of two programmes of ergonomic intervention in the home, with respect to levels of functionality (performance of activities of daily living) and the quality of life of post-stroke patients, by reference to a control group.
- Conditions
- Stroke, Quality of Life
- Being tested
- Ergonomic adjustments, Kinesiotherapy plus ergonomic adjustments, Healthcare education
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic adjustmentsOther
The ergonomic adjustments made were based on a prior assessment of the patient's needs in this respect, using a purpose-made home inspection form .
Kinesiotherapy plus ergonomic adjustmentsOther
This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises).
Healthcare educationOther
This group received health education information, based on an illustrated manual with advice for patients with chronic stroke.
| Study group | Role | What they receive |
|---|---|---|
| Ergonomic adjustment group | Experimental | Ergonomic intervention program at home for post-stroke patients. The ergonomic adjustments made were based on a prior assessment of the patient's needs in this respect, using a purpose-made home inspection form. Receives: Other: Ergonomic adjustments |
| Kinesiotherapy + ergonomics group | Experimental | A Kinesiotherapy plus ergonomic adjustments program for post-stroke patients. This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises). Receives: Other: Kinesiotherapy plus ergonomic adjustments |
| Healthcare education | Active comparator | A conservative intervention program for post-stroke patients Receives: Other: Healthcare education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 12 weeks
The quality of life is assessed on the WHOQoL-Bref scale, on a range from 0 to 100 points, where 100 is the highest level of quality of life. For each domain, with the exception of the first two questions, the quality of life was considered to be impaired when a score <70 points was assigned.
Measured: Twelve weeks
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 24 weeks
The quality of life is assessed on the WHOQoL-Bref scale, on a range from 0 to 100 points, where 100 is the highest level of quality of life. For each domain, with the exception of the first two questions, the quality of life was considered to be impaired when a score <70 points was assigned.
Measured: Twenty four weeks
Secondary outcomes (2)
Change from the Older Americans Resources and Services (OARS) scale at 12 weeks
Functional capacity is measured using the Older Americans Resources and Services (OARS) scale, which consists of two parts. The Brazilian-language version of this scale allows each part to be used independently. Each item is scored according to a Likert scale, ranging from 0 to 2 points, where 0 indicates a total level of dependence for the performance of ADL, 1 point corresponds to partial independence, and 2 points represents a satisfactory level of independence. The scale consists of 15 items that evaluate activities such as using the telephone, transport, shopping, preparing and consuming food, cleaning and housework, administering medicines, financial affairs, dressing and undressing, personal hygiene and grooming, functional mobility, getting into and out of bed, bathing and mobility in the bathroom.
Measured: Twelve weeks
Change from the Older Americans Resources and Services (OARS) scale at 24 weeks
Functional capacity is measured using the Older Americans Resources and Services (OARS) scale, which consists of two parts. The Brazilian-language version of this scale allows each part to be used independently. Each item is scored according to a Likert scale, ranging from 0 to 2 points, where 0 indicates a total level of dependence for the performance of ADL, 1 point corresponds to partial independence, and 2 points represents a satisfactory level of independence. The scale consists of 15 items that evaluate activities such as using the telephone, transport, shopping, preparing and consuming food, cleaning and housework, administering medicines, financial affairs, dressing and undressing, personal hygiene and grooming, functional mobility, getting into and out of bed, bathing and mobility in the bathroom.
Measured: Twenty four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 May 2017
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 34 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
- Investigators
- José Manuel Pérez Mármol, Principal investigator, Department of Physiotherapy. Faculty of Health Sciences, University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665220
- Sponsor's protocol ID
- Rehab in post-stroke patients
- Status last verified
- Jul 2021
- First submitted
- 6 Sep 2018
- Last updated
- 7 Jul 2021
- 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 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Home Ergonomics Programmes on Post-stroke Patients' Quality of Life and Functional Capacity: a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03665220
- Acronym / sponsor ID
- Rehab in post-stroke patients
- Conditions
- Stroke, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 11 Sep 2018 (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 main objective of the clinical trial is to evaluate the effectiveness of two home ergonomics programmes, by reference to a control group, on functional capacity and quality of life in post-stroke patients.
Detailed description
For post-stroke patients, rehabilitation must address different aspects. When the resulting condition has become established, treatment should take the form of a mixed intervention model, incorporating preventive, rehabilitational and compensatory or adaptive approaches, aimed at enhancing the patient's performance within the environment. Physiotherapy and occupational therapy are key disciplines in the composition of multi- and inter-disciplinary teams for the care of stroke patients. In this clinical trial we evaluate the effectiveness of two programmes of ergonomic intervention in the home, with respect to levels of functionality (performance of activities of daily living) and the quality of life of post-stroke patients, by reference to a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ergonomic adjustment group | Experimental | Other: Ergonomic adjustmentsErgonomic intervention program at home for post-stroke patients. The ergonomic adjustments made were based on a prior assessment of the patient's needs in this respect, using a purpose-made home inspection form. |
| Kinesiotherapy + ergonomics group | Experimental | Other: Kinesiotherapy plus ergonomic adjustmentsA Kinesiotherapy plus ergonomic adjustments program for post-stroke patients. This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises). |
| Healthcare education | Active comparator | Other: Healthcare educationA conservative intervention program for post-stroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stroke diagnosed 6-24 months previously
- aged over 18 years
- ability to speak and understand Portuguese.
Key exclusion criteria (5 listed)
- severe cognitive deficit
- severe aphasia
- other associated neurological disease
- musculoskeletal pathology
- drug or alcohol abuse.
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 adjustmentsThe ergonomic adjustments made were based on a prior assessment of the patient's needs in this respect, using a purpose-made home inspection form . | Other | Ergonomic adjustment group |
| Kinesiotherapy plus ergonomic adjustmentsThis group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises). | Other | Kinesiotherapy + ergonomics group |
| Healthcare educationThis group received health education information, based on an illustrated manual with advice for patients with chronic stroke. | Other | Healthcare education |
Primary outcome
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 12 weeks
Time frame: Twelve weeks
The quality of life is assessed on the WHOQoL-Bref scale, on a range from 0 to 100 points, where 100 is the highest level of quality of life. For each domain, with the exception of the first two questions, the quality of life was considered to be impaired when a score <70 points was assigned.
Change from the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 24 weeks
Time frame: Twenty four weeks
The quality of life is assessed on the WHOQoL-Bref scale, on a range from 0 to 100 points, where 100 is the highest level of quality of life. For each domain, with the exception of the first two questions, the quality of life was considered to be impaired when a score <70 points was assigned.
2 secondary outcomes
Change from the Older Americans Resources and Services (OARS) scale at 12 weeks
Time frame: Twelve weeks
Change from the Older Americans Resources and Services (OARS) scale at 24 weeks
Time frame: Twenty four 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 7 Jul 2021.
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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.
José Manuel Pérez Mármol principal investigator
Department of Physiotherapy. Faculty of Health Sciences, University of Granada
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 adjustments, Kinesiotherapy plus ergonomic adjustments and Healthcare education 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 3 inclusion and 5 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 7 Jul 2021. 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 the World Health Organization's Quality of Life Questionnaire (WhoQol-Bref) at 12 weeks (time frame: Twelve 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?
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 7 Jul 2021.