Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04901637 |
| Other study ID # |
KAEK/2019.03.61 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2019 |
| Est. completion date |
May 30, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Kanuni Sultan Suleyman Training and Research Hospital |
| Contact |
Tugba Sahbaz, MD |
| Phone |
05368289936 |
| Email |
piskint[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
