StrokeNCT04901637
Musculoskeletal Problems in Caregivers of Stroke Survivors
An observational study of Stroke and Caregiver Burnout, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Stroke is one of the major causes of neurological disability in adults globally. Fifteen million patients suffer from stroke annually throughout the world, from which 5 million had to continue to live with a major disability. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Caregiver Burnout
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2019to 30 May 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were eligible if they had a stroke according the WHO definition at least 6 months prior, who need assistance with the activities of daily life(ADL) and are older than 18 years of age and the informal caregivers over the age of 18, who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance were included in the study.
Who may be able to join
- For stroke survivors:
- Patients were eligible if they had a stroke according the WHO definition at least 6 months prior,
- Who need assistance with the activities of daily life(ADL)
- Older than 18 years of age
- For caregivers:
- Older than 18 years of age
- Who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance
Who cannot join
- For caregivers:
- Who are above the age of 65
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital,
Istanbul, Kucukcekmece, 39750
Tugba Sahbaz, MD, 05368289936 ext. +90, piskint@gmail.com
About this study
Stroke is one of the major causes of neurological disability in adults globally. Fifteen million patients suffer from stroke annually throughout the world, from which 5 million had to continue to live with a major disability. Especially in developing and non-developing countries, it contributes significantly to the mortality and morbidity.
The improvements in medical care of acute stroke, especially in a specialized stroke unit setting, reduced overall mortality of the disease. However, the general prognosis of stroke survivors did not improve accordingly, so that many survivors have to deal with different forms of disability. Following a stroke, patients usually suffer from variable degrees of disability. They require acute treatment at an inpatient setting and extensive assistance throughout their recovery at home. Most stroke survivors depend on informal caregivers, who usually is a family member (eg, spouse) providing unpaid care for the patient.Caregivers are usually unprepared and unfit for such a support after discharge. And as a result, they may experience a decline in their physical and mental health status, social life and general well-being
The current study sought to examine the musculoskeletal problems of the informal caregivers in relation with the physical condition and the degree of disability of the patient they are caring. To our knowledge this study can be considered as the first of its kind by evaluating the symptoms of the caregiver from their viewpoint and relates the level of their symptoms to the level of incapacity of the stroke patient.
Read the detailed description
In our observational study, we evaluated the cross-sectional survey data of the informal caregivers who had provided care for stroke patients. The convenience sampling method was used to assemble the study population. Consecutive informal caregivers accompanying stroke survivors to the outpatient stroke clinic at Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, Turkey were included in our study.
Patients were eligible if they (1) had a stroke according to the WHO definition at least 6 months prior, who need assistance with the activities of daily life(ADL) and are older than 18 years of age.
The informal caregivers over the age of 18, who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance were included in the study. Caregivers, who are above the age of 65, who have underlying comorbid illnesses, neurological disability, or psychiatric disabilities that would hinder their capacity to deliver care were removed from the study. Because of the negative effects of aging on the musculoskeletal system, caregivers over 65 years of age were also excluded.
Data forms, designed by the researchers, were used to record information on each caregiver's age, gender, educational level, employment status, and relationship with stroke survivor. Respective stroke survivors' data were also recorded.
Validated scales were used to assess the physical condition and disability levels of stroke survivors. Modified Ashworth Scale (MAS) was used to quantify the spasticity of the upper and the lower extremity muscles. MAS is a 6-point rating scale. The lowest score is 0 and means "no increase in muscle tone," while the highest score 4 shows that the affected limb is rigid during flexion or extension
Evaluation of motor recovery was assessed using the Brunnstrom staging system, which is a motor and tonus analysis system. It lays down six different grades for the upper and lower extremity and hand. The flask phase with the lack of the slightest level of movement is stage 1, while the presence of isolated movements is assessed as stage 6.
The level of disability was measured using the functional independence measure (FIM), which has been validated and is reliable in the Turkish population. It includes 18 items measuring performance in communication, self-care, social cognition, locomotion, transfer, and sphincter control. The motor function score is also given separately in addition to the total score.
Functional Ambulation Score (FAS) was used to assess the ambulatory status of the patients. It specifies the patients' functional capacity of walking under 6 headings. A patient with a score of 0 cannot walk at all, while a patient with 5 can ambulate independently. The FAS scale appraises the need for human assistance instead of devices and supports.
The informal caregivers were evaluated by using Extended Nordic Musculoskeletal Questionnaire (NMQ-E), Caregiver burden inventory (CBI) and Beck Depression Scale(BDS).
The effect of musculoskeletal symptoms during the last 6 months was evaluated using the NMQ-E, which is a one-page survey evaluating nine body regions: hand/wrist, elbow, shoulder, neck, upper back, low back, hip/thigh, knee and foot/ankle. Responses were provided as 'trouble, including ache, pain and discomfort. Only musculoskeletal symptoms (affecting joints, muscles, and bones) were asked about in order to rule out other symptoms like neuropathic or abdominal pain.
To assess the perceived burden of care, a validated Turkish version of the Caregiver Burden Inventory (CBI) was used. CBI is a self-administered 24-item questionnaire with five domains: time dependency, developmental, physical, social, and emotional pressures. All objects are scored on a 5-point Likert scale, with 0 being the least disruptive (not at all disruptive) and 4 being the most disruptive (very disruptive). The global score is calculated by adding the subscale scores together. Greater caregiver burden is shown by higher ratings.
The Beck Depression Scale (BDS), developed by Beck et al.) and adapted to Turkish by Hisli, was used to assess depression. The scale has 21 items with scores ranging from 0 to 3. The highest possible score is 63, which indicates extreme depression. The Turkish validity and authenticity have also been shown.
Nordic extended scores of the caregivers were first compared with the various disability scores of the patients and then with their own BECK and CBI scores. Correlations between those scores are recorded.
- Conditions
- Stroke, Caregiver Burnout
- Medical subject headings
- Stroke, Caregiver Burden
What is being measured
The primary outcome is the main question the study is designed to answer.
Extended Nordic Musculoskeletal Questionnaire
The effect of musculoskeletal symptoms during the last 6 months was evaluated using the NMQ-E, which is a one-page survey evaluating nine body regions: hand/wrist, elbow, shoulder, neck, upper back, low back, hip/thigh, knee and foot/ankle.Responses were provided as 'trouble, including ache, pain and discomfort'.Only musculoskeletal symptoms (affecting joints, muscles, and bones) were asked about in order to rule out other symptoms like neuropathic or abdominal pain.
Measured: 1 interview day
Caregiver Burden Inventory
BI is a self-administered 24-item questionnaire with five domains: time dependency, developmental, physical, social, and emotional pressures. All objects are scored on a 5-point Likert scale, with 0 being the least disruptive (not at all disruptive) and 4 being the most disruptive (very disruptive). The global score is calculated by adding the subscale scores together. Greater caregiver burden is shown by higher ratings
Measured: 1 interview day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start30 May 2019
- Primary completion30 May 2021 (estimated)
- Study completion30 May 2021 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Sahbaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Tugba Sahbaz, MD, Principal investigator, University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901637
- Sponsor's protocol ID
- KAEK/2019.03.61
- Status last verified
- Jun 2021
- First submitted
- 21 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahbaz T, Medin-Ceylan C. Stroke severity to determine musculoskeletal symptoms in family caregivers. Rev Lat Am Enfermagem. 2023 Oct 9;31:e4004. doi: 10.1590/1518-8345.6725.4004. eCollection 2023.
PubMed 37820216
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Problems in Caregivers of Stroke Survivors
- ClinicalTrials.gov ID
- NCT04901637
- Acronym / sponsor ID
- KAEK/2019.03.61
- Conditions
- Stroke, Caregiver Burnout
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 25 May 2021 (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.
Stroke is one of the major causes of neurological disability in adults globally. Fifteen million patients suffer from stroke annually throughout the world, from which 5 million had to continue to live with a major disability. Especially in developing and non-developing countries, it contributes significantly to the mortality and morbidity.
The improvements in medical care of acute stroke, especially in a specialized stroke unit setting, reduced overall mortality of the disease. However, the general prognosis of stroke survivors did not improve accordingly, so that many survivors have to deal with different forms of disability. Following a stroke, patients usually suffer from variable degrees of disability. They require acute treatment at an inpatient setting and extensive assistance throughout their recovery at home. Most stroke survivors depend on informal caregivers, who usually is a family member (eg, spouse) providing unpaid care for the patient.Caregivers are usually unprepared and unfit for such a support after discharge. And as a result, they may experience a decline in their physical and mental health status, social life and general well-being
The current study sought to examine the musculoskeletal problems of the informal caregivers in relation with the physical condition and the degree of disability of the patient they are caring. To our knowledge this study can be considered as the first of its kind by evaluating the symptoms of the caregiver from their viewpoint and relates the level of their symptoms to the level of incapacity of the stroke patient.
Detailed description
In our observational study, we evaluated the cross-sectional survey data of the informal caregivers who had provided care for stroke patients. The convenience sampling method was used to assemble the study population. Consecutive informal caregivers accompanying stroke survivors to the outpatient stroke clinic at Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, Turkey were included in our study.
Patients were eligible if they (1) had a stroke according to the WHO definition at least 6 months prior, who need assistance with the activities of daily life(ADL) and are older than 18 years of age.
The informal caregivers over the age of 18, who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance were included in the study. Caregivers, who are above the age of 65, who have underlying comorbid illnesses, neurological disability, or psychiatric disabilities that would hinder their capacity to deliver care were removed from the study. Because of the negative effects of aging on the musculoskeletal system, caregivers over 65 years of age were also excluded.
Data forms, designed by the researchers, were used to record information on each caregiver's age, gender, educational level, employment status, and relationship with stroke survivor. Respective stroke survivors' data were also recorded.
Validated scales were used to assess the physical condition and disability levels of stroke survivors. Modified Ashworth Scale (MAS) was used to quantify the spasticity of the upper and the lower extremity muscles. MAS is a 6-point rating scale. The lowest score is 0 and means "no increase in muscle tone," while the highest score 4 shows that the affected limb is rigid during flexion or extension
Evaluation of motor recovery was assessed using the Brunnstrom staging system, which is a motor and tonus analysis system. It lays down six different grades for the upper and lower extremity and hand. The flask phase with the lack of the slightest level of movement is stage 1, while the presence of isolated movements is assessed as stage 6.
The level of disability was measured using the functional independence measure (FIM), which has been validated and is reliable in the Turkish population. It includes 18 items measuring performance in communication, self-care, social cognition, locomotion, transfer, and sphincter control. The motor function score is also given separately in addition to the total score.
Functional Ambulation Score (FAS) was used to assess the ambulatory status of the patients. It specifies the patients' functional capacity of walking under 6 headings. A patient with a score of 0 cannot walk at all, while a patient with 5 can ambulate independently. The FAS scale appraises the need for human assistance instead of devices and supports.
The informal caregivers were evaluated by using Extended Nordic Musculoskeletal Questionnaire (NMQ-E), Caregiver burden inventory (CBI) and Beck Depression Scale(BDS).
The effect of musculoskeletal symptoms during the last 6 months was evaluated using the NMQ-E, which is a one-page survey evaluating nine body regions: hand/wrist, elbow, shoulder, neck, upper back, low back, hip/thigh, knee and foot/ankle. Responses were provided as 'trouble, including ache, pain and discomfort. Only musculoskeletal symptoms (affecting joints, muscles, and bones) were asked about in order to rule out other symptoms like neuropathic or abdominal pain.
To assess the perceived burden of care, a validated Turkish version of the Caregiver Burden Inventory (CBI) was used. CBI is a self-administered 24-item questionnaire with five domains: time dependency, developmental, physical, social, and emotional pressures. All objects are scored on a 5-point Likert scale, with 0 being the least disruptive (not at all disruptive) and 4 being the most disruptive (very disruptive). The global score is calculated by adding the subscale scores together. Greater caregiver burden is shown by higher ratings.
The Beck Depression Scale (BDS), developed by Beck et al.) and adapted to Turkish by Hisli, was used to assess depression. The scale has 21 items with scores ranging from 0 to 3. The highest possible score is 63, which indicates extreme depression. The Turkish validity and authenticity have also been shown.
Nordic extended scores of the caregivers were first compared with the various disability scores of the patients and then with their own BECK and CBI scores. Correlations between those scores are recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were eligible if they had a stroke according the WHO definition at least 6 months prior, who need assistance with the activities of daily life(ADL) and are older than 18 years of age and the informal caregivers over the age of 18, who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance were included in the study.
Key inclusion criteria (7 listed)
- Patients were eligible if they had a stroke according the WHO definition at least 6 months prior,
- Who need assistance with the activities of daily life(ADL)
- Older than 18 years of age
- Older than 18 years of age
- Who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance
Key exclusion criteria (2 listed)
- Who are above the age of 65
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extended Nordic Musculoskeletal Questionnaire
Time frame: 1 interview day
The effect of musculoskeletal symptoms during the last 6 months was evaluated using the NMQ-E, which is a one-page survey evaluating nine body regions: hand/wrist, elbow, shoulder, neck, upper back, low back, hip/thigh, knee and foot/ankle.Responses were provided as 'trouble, including ache, pain and discomfort'.Only musculoskeletal symptoms (affecting joints, muscles, and bones) were asked about in order to rule out other symptoms like neuropathic or abdominal pain.
Caregiver Burden Inventory
Time frame: 1 interview day
BI is a self-administered 24-item questionnaire with five domains: time dependency, developmental, physical, social, and emotional pressures. All objects are scored on a 5-point Likert scale, with 0 being the least disruptive (not at all disruptive) and 4 being the most disruptive (very disruptive). The global score is calculated by adding the subscale scores together. Greater caregiver burden is shown by higher ratings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Derived from this study: PubMed 37820216Sahbaz T, Medin-Ceylan C. Stroke severity to determine musculoskeletal symptoms in family caregivers. Rev Lat Am Enfermagem. 2023 Oct 9;31:e4004. doi: 10.1590/1518-8345.6725.4004. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Tugba Sahbaz, MD principal investigator
University of Health Sciences, Kanuni Sultan Süleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Caregiver Burnout, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tugba Sahbaz, MD (05368289936 ext. +90, piskint@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extended Nordic Musculoskeletal Questionnaire (time frame: 1 interview day). 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 NCT04901637, 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 4 Jun 2021.