The Effects of Core Stabilization Exercises With Swisball in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke, Cardiovascular

• Registration Number: NCT04777955
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

Stroke is often associated with secondary complications such as nutritional and metabolic disorders, endocrine dysfunction, mental problems, and cardiopulmonary disorders caused by neurological and musculoskeletal deficits. The absence of the paretic side muscles and the difficulty of movement together with restrictive pulmonary disorders trigger a secondary decrease in cardiopulmonary function and expose insufficient energy associated with gait resulting in a decrease in asymmetric trunk exercise endurance.

Detailed Description

Studies have shown that these patients have muscle weakness and delayed activity of trunk muscles, significant loss of trunk position sense, insufficient pressure control center while sitting, decreased trunk performance, and trunk asymmetry during walking. It has been reported that trunk function with balance and walking ability in stroke patients is a useful determinant of daily life activities, balance and walking ability. Balance disorders may be the result of changes in the sensory and integrative aspects of motor control. In the subacute phase, more than 80% of the subjects who have had stroke for the first time have an imbalance in their balance. After a stroke, upper motor neuron damage can cause unconditioned. This results in physical inactivity and decreased cardiorespiratory fitness. Respiratory muscle weakness and changes in thoraco-abdominal motion may be associated with a decrease in tidal volume and lower exercise tolerance.

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-02
• Study Start: 2021-05-04
• Primary Completion: 2022-05-08
• Study Completion: 2022-06-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Unilateral and first time stroke
2. Ability to understand and follow verbal instructions
3. Brunnstrom healing phase being above 3 for lower limbs;
4. Ability to walk 10 m distance independently, with or without a mobility assistant.
5. Patients who can sit on a stable surface for 30 seconds
6. Patients without respiratory diseases or injuries

Exclusion Criteria

1. Neurological disorders other than stroke that could potentially affect balance and ambulation;
2. Body failure scale score below 10 points
3. Apraxia and hemineglect
4. 80 years and older
5. Orthopedic disorders or rib fracture
6. Patients with neglect syndrome
7. A history of seizures or a family history of epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory Function Tests	5 min	Respiratory functions will be measured using portable spirometry.
Maximum inspiratory and expiratory oral pressures	1 min	Respiratory muscle strength will be assessed by measuring maximal inspiratory and expiratory pressures.
Muscle Thickness Measurement With Ultrasound	10 min	Using external oblique (EO), Internal oblique (IO), Transversus abdominis (TrA), rectus abdominis muscles (RA) and diaphragm thickness, ultrasonic imaging system (M-TurboTM, Sono Site Canada, Inc., Markham, ON, Canada) It will be measured. A 5-2 MHz linear probe will be used to measure EO, IO, TrA and RA, and a 5-2 MHz convex probe for diaphragm measurement.

Secondary Outcome Measures

Name	Time	Method
10 Meter Walk Test	1 min	Subjects are told to walk 14 meters. The middle 10 meters of 14 meters should be marked on the ground. Measurement begins when the patient crosses the line indicating the start of the 10 m path on the floor. After 10 meters, the stopwatch is stopped, but continues until the patient reaches the end of 14 meters. Subjects are told to walk at their preferred walking speed.
Tinetti Balance Scale	5 min	The Tinetti Rating scale is a scale of 0 to 2 rows. 0 points represent the most disorder and 2 points represent independence. Individual points are then combined to form three subsections; overall gait assessment score, overall balance assessment score, and combined gait and balance score. The maximum score for the walking component is 12. The maximum score for the balance component is 16. The maximum total score is 28. In general, participants who score below 19 have a high risk of falling. It indicates that the participants who scored between 19-24 are at risk of falling medium.
Brunnstrom Evaluation Scale	1 min	Brunnstrom consists of 3 parts: The hand is scored on a 6-level Likert-type scale, in the form of upper and lower extremity sections. Higher levels represent better motor function. Disease stages are graded based on the patient's spasticity and movement.
Stroke Impact Scale	10 min	Stroke Impact Scale (ISS) has been developed to be a more comprehensive measure of health outcomes for stroke populations. IES includes meaningful dimensions of function and health-related quality of life in the form of a self-assessment questionnaire. The 3rd version of the ISS includes 59 items and 8 sub-sections (power, hand function, activities and independent activities of daily life, mobility, communication, emotion, memory and thinking and participation / role function) and evaluates.
Trunk Impairment Scale	5 min	Trunk Impairment Scale (TIS) is a valid and reliable sequential scale for measuring dynamic sitting balance, trunk coordination and trunk control. It evaluates the selective movements of lateral flexion and trunk rotation initiated from the upper and lower parts of the trunk. SMS consists of three subgroups: static settlement balance, dynamic settlement balance and coordination. Each sub-dimension contains three to ten items. TIS score is between 0 and 23.
Fatigue Severity Scale	1 min	The fatigue severity scale is a 9-item survey that investigated the severity of fatigue in different situations over the past week.
Postural Evaluation Scale for Patients with Stroke	3 min	Postural Evaluation Scale for Patients with Stroke (PASS) It is specially designed for paralyzed patients. PASS contains a total of 12 items to assess balance. It contains 5 items to evaluate posture (static PASS) and 7 items to evaluate changes in posture (dynamic PASS). PASS can be used to evaluate functional balance that requires both static and dynamic balance. Each PASS item is rated from 0 to 3 for a 36-point survey. At this scale, the higher the score, the more positive the balance in stroke patients.
Peak Cough Flow Rate	2 min	In the study, the highest cough flow rate will be measured with a portable PEF meter. All measurements will be made by a trained physiotherapist using the technique described by Fiore et al. Subjects will be asked to "take a deep breath and cough as hard as possible" in a semi-sitting position (60 degrees).
Timed Up and Go Test	2 min	It measures the time it takes for a person to stand up from a seat, walk a distance of 3 m, turn, sit back on the chair. It is a scale originally developed as a clinical measure of balance in the elderly and scored between 1 and 5 on the basis of an observer's perception of the participant's risk of falling during the test. Podsiadlo and Richardson timed the test and changed the original test and suggested using it as a short test of basic mobility skills for the elderly living in the weak community.
Functional Ambulation Scale	1 min	Functional ambulation scale consisting of a sensitive and reliable scale for gait evaluation in stroke patients will be evaluated. On this scale, the score can range from 0 (being unable to walk or needing the help of two therapists) to 5 (being independent during the movement).

Trial Locations

Locations (1)

Istanbul University Cerrahpasa; 🇹🇷 İstanbul, Turkey