We carried out prospective cohort study which involved at first 216 survivors. Out of all of them 11 dropped out, 9 died, 60 didn’t go to inpatient rehabilitation. Finally, cohort included 136 stroke survivors aged 40-79 years of age from the teritory of the Southeastern Serbia. All stroke survivors had inpatient rehabilitation in tertiary health institutions in the period of 30 days at Clinic for Physical Medicine and Rehabilitation, of the Clinical Centre Niš, Serbia, followed by prolonged rehabilitation in spa conditions for 30 days under medical control.
In Serbia, most stroke survivors with functional deficit after acute treatment in intensive care units (ICU) are offered 14 to 30 days of inpatient rehabilitation. Rehabilitation begins in the ICU when patient state is stable and after discharged majority of survivors from the territory of the Southeastern Serbia continuate rehabilitation at the Clinic for Physical Medicine and Rehabilitation, of the Clinical Centre Niš.
The inclusion criteria were: the first-ever stroke, the age from 40 to 79 years, possible communication with all participants and the written consent of all participants to participate in the study.
The excluding criteria were: previously experienced stroke, pre-stroke cognitive impairments, insufficient cooperation of patients, psycho-organic syndrome, aphasia, transistent ischaemic attack (TIA), new stroke within 90 days of the first stroke, complications after stroke, the death of the participant.
The study took place from 1 April 2012 to 1 April 2016. The first assessments (baseline) were done at the admission to the Clinic for Rehabilitation and Physical Medicine and included functional status, cognitive function, neurological status and HRQOL. Data about survivors and stroke-related clinical characteristics were collected too. The second assessments were done six months after discharged from rehabilitation.
Functional status
Functional status was assessed with Barthel Index (BI) and by the modified Rankin scale (mRS).
BI measures the patient’s performance in 10 activities of Activities of Daily Living (ADL), a group of questions that is related to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and a group related to mobility (ambulation, transfers, and stair climbing). The maximal score for BI is 100 indicating that the patient is fully independent in physical functioning. The lowest score is 0, representing a totally dependent bedridden state [22].
The modified Rankin scale (mRS) [23] is regarded as a global stroke scale scoring patients’ daily functioning from 0 (no symptoms) to 5 (severe disability, bedridden, in need of constant care) or 6 (death). Higher points indicate a severe disability.
Cognitive function assessment
Cognitive function was assessed by the Mini Mental State Examination (MMSE). MMSE is considered as a useful measure for the assessment of cognitive decline in stroke survivors [24]. This scale examines orientation, memorizing, attention and calculation, delayed memory, speaking, reading, writing and drawing. The maximum score is 30, and a score of less than 24 points indicates the cognitive impairments.
The National Institutes of Health Stroke Scale
Neurological impairments were assessed by the National Institutes of Health Stroke Scale (NIHSS). This scale is consisted of 15 items for evaluation of size and location of stroke in the acute phase and as measure of neurological handicap. Total scores range from 0 to 42 and higher scores indicate greater stroke severity [25].
The Stroke Impact Scale
The Stroke Impact Scale (SIS) is a stroke-specific and self-reported questionnaire which consists of 59 items measuring eight domains (strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, and participation role). Each domain of SIS has a range of 0–100 and higher scores indicated better HRQOL [26].
The statistical analysis
All the calculations were done into the SPSS software package version 18.0 and S-PLAS programme, version 2000. Student's t-test was used to compare numerical differences of normal distribution and the Mann-Whitney U test was used to compare two values when there were not normally distributed. Chi squared test and Fisher's test of exact probability were used too.
The Pearson's correlation analysis was calculated for the association among the continuous variables (age, BI, mRS, MMSE, NIHSS). Effects of independent variables (for continuous variables) on the dependent variable (SIS domains) were assessed by multivariate stepwise linear regression analysis. Regression coefficient (B) and the 95% confidence intervals (95%CI for B) were calculated too. Statistical significance was accepted when the corresponding p-values was less than 0.05 (p<0.05).