The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial
2. Materials and Methods
2.1. Study Design and Setting
Patient and Public Involvement Subsection
2.4. Selection Criteria
- First ever-stroke ≤ 30 days (diagnostic criteria according to the World Health Organisation definition; corresponding to ICD-9 code 434) whether cortical or subcortical, and ischemic or hemorrhagic.
- Unilateral localisation of the stroke verified by computed tomography; if a patient shows previous problems, but does not have any neurological or clinical impairment, he/she would be included in the study.
- Both sexes and age ≥ 18 years old.
- Ability to understand and execute simple instructions.
- Severity of stroke by the Spanish National institute of Health Stroke Scale (S-NIHSS)  score ≥ 2 points.
- Modified Rankin Scale  > 2 points before stroke.
- Concurrent neurological disorder (e.g., Parkinson’s disease) or major orthopedic problem (e.g., amputation) that hampers sitting balance.
- Relevant psychiatric disorders that may prevent from following instructions.
- Other treatments that could influence the effects of the interventions.
- Contraindication to physical activity (e.g., heart failure).
- Use of cardiac pacemakers.
- Patients with hemorrhagic strokes that have undergone surgery for intracranial decompression.
- Patients whose stroke occurs exclusively and only in the cerebellum and brainstem. Patients whose main stroke is localised on another area and who also have a small lesion in the cerebellum and brainstem would not be excluded.
2.6. Participant Timeline
2.7. Outcomes Measures
- Dynamic sitting balance and coordination measured by S-TIS 2.0 . This scale is a Spanish version of the Trunk Impairment Scale version 2.0 . This scale aims to evaluate the trunk in patients who have suffered a stroke. The dynamic subscale contains items on the lateral flexion of the trunk and unilateral lifting of the hip. To assess the coordination of the trunk, the individual is asked to rotate the upper or lower part of his or her trunk six times, initiating the movements either from the shoulder girdle or from the pelvic girdle, respectively. There are two subscales; the first one has 10 items and the second one has six. The highest possible total score is consequently 16 points, which indicates an optimal dynamic sitting balance and sitting coordination. If the patient cannot maintain a sitting position for 10 s without back and arm support, with hands on thighs, feet in contact with the ground and knees bent at 90° (starting position), the total score for the scale is 0 points. This scale is utilised for inclusion criteria, and at T0, T1, T2, T3 and T4.
- Gait by stepping section of Brunel Balance Assessment (BBA) . It is designed to assess functional balance for people with a wide range of abilities, and has been tested specifically for use post-stroke. There are three sections to the assessment: sitting, standing and stepping. In this study, only the stepping section is utilised. It consists of six levels to assess standing functional balance and a 5-m walk. At each level, the patient receives a score for his/her efforts. This gives an indication on whether the patient is improving within a level, even if he/she is not able to progress to the next level. The score also reflects how well the individual is functioning within that stepping section. The higher score is six points, and the individual is able to walk 5 m independently. Stepping is evaluated at T0, T1, T2, T3 and T4.
- Sitting functional balance is assessed by the Spanish version of Function in Sitting test (S-FIST) . It is a bedside evaluation of sitting balance and functional sitting everyday activities that assess sensory, motor, proactive, reactive and steady balance factors. The S-FIST consists of 14 tested parameters with an ordinal scale (0–4) for each test item, with 0 indicating the lowest level of function and 4 the highest level. Each participant sat at the edge of a standard hospital bed without air mattresses, with the proximal thigh (1/2 femur length) supported by the bed. The bed height was adjusted and a step stool was used if necessary to bring the hips and knees to approximately 90° flexion, with both feet flat on the floor or stool. The higher score is 56 points. Sitting functional balance is evaluated at T0, T2, T3 and T4.
- Standing balance and risk of falling is evaluated by Berg Balance Scale (BBS) [58,59]. It provides a psychometrically sound measure of balance impairment. It is used objectively determine a patient’s ability (or inability) to safely balance during a series of predetermined tasks. It is a 14-item scale; patients must maintain positions and complete moving tasks of varying difficulty. In most items, patients must maintain a given position for a specified time. Each item consists of a 5-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest. A score of 56 indicates functional balance. A score of < 45 indicates that individuals may be at greater risk of falling. BBS is assessed at T0, T2, T3 and T4.
- Postural control is evaluated by the Spanish version of Postural Assessment Scale for Stroke (S-PASS) . It was designed specifically for patients with a stroke, regardless of postural competence. It has two subscales: mobility and balance. The first measures the patient’s ability to change position from lying, sitting and standing, and the second in maintaining stable postures in sitting and standing. The S-PASS consists of 12 items with a 4-point scale, where items are scored from 0–3. The higher score is 36 points, indicating an optimal postural control. It is evaluated at T0, T2, T3 and T4.
- Lower limb spasticity by Modified Ashworth Scale (MAS) . This tool measures resistance during passive soft-tissue stretching of muscle. It is performed while the assessor moves the hip adductors, knee extensors and ankle plantar flexors in the supine and lateral position. The MAS is assessed at T0, T2, T3 and T4.
- ADL by Barthel Index (BI) . This shows the degree of independence of a patient from any assistance. It covers 10 domains of function (activities): bowel and bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs and bathing. The ADL is evaluated at T0, T2, T3 and T4.
- Health-related quality of life is measured by the Spanish-version of 5-Dimensions Questionnaire (EQ-5D-5L) [63,64]. It is a generic patient’s health-related quality of life measurement with evidence of good reliability and validity in various disease populations, including strokes. Patients chose five levels of severity (1, no problem; 2, slight problem; 3, moderate problem; 4, severe problem; and 5, unable to function/extreme problem) in five dimensions (mobility, self-care, usual activity, pain/discomfort and depression/anxiety), and rated their overall health status via the EQ-VAS. Quality of life is assessed at T0, T2, T3 and T4.
- Rate of falls is measured by a specific registry created specifically for this study. The outcome is defined as the average number of falls per patient during the intervention period and follow-up. It is recorded at T0 (falls before stroke), T2, T3 and T4.
- Gait speed is assessed by BTS G-Walk. It is a wireless system consisting of an inertial sensor composed by a triaxial accelerometer, a magnetic sensor and a triaxial gyroscope that was positioned on S1 vertebrae. From the data acquired, the system extrapolates all spatial-temporal gait. The patient walks for one minute without being aided; this variable is only performed if the patient has a 6-point stepping section of BBA.
2.8. Statistical Analysis
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
|ADL||Activities of daily living|
|BBA||Brunel Balance Assessment|
|BBS||Berg Balance Scale|
|CSEs||Core Stability exercises|
|mRS||Modified Rankin Scale|
|NIHSS||National Institute of Health Stroke Scale|
|QoL||Quality of life|
|RCT||Randomized controlled trial|
|S-FIST||Spanish version of Function in Sitting Test|
|S-PASS||Spanish version of Postural Assessment Scale for Stroke|
|S-TIS 2.0||Spanish version of Trunk Impairment Scale|
|TENS||Transcutaneous electrical nerve stimulation|
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Cabanas-Valdés, R.; Boix-Sala, L.; Grau-Pellicer, M.; Guzmán-Bernal, J.A.; Caballero-Gómez, F.M.; Urrútia, G. The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial. Int. J. Environ. Res. Public Health 2021, 18, 6615. https://doi.org/10.3390/ijerph18126615
Cabanas-Valdés R, Boix-Sala L, Grau-Pellicer M, Guzmán-Bernal JA, Caballero-Gómez FM, Urrútia G. The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial. International Journal of Environmental Research and Public Health. 2021; 18(12):6615. https://doi.org/10.3390/ijerph18126615Chicago/Turabian Style
Cabanas-Valdés, Rosa, Lídia Boix-Sala, Montserrat Grau-Pellicer, Juan Antonio Guzmán-Bernal, Fernanda Maria Caballero-Gómez, and Gerard Urrútia. 2021. "The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial" International Journal of Environmental Research and Public Health 18, no. 12: 6615. https://doi.org/10.3390/ijerph18126615