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NCT Number: NCT04777955

The Effects of Core Stabilization Exercises With Swisball in Stroke Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa

Istanbul, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

core stabilization exercises

Other

Core is at the center of almost all kinetic chains in the body. Core force, balance, and motion control maximize all kinetic chains of upper and lower limb function. A stable and strong core can contribute to more efficient use of the lower extremities. Core stability is defined as the ability of the lumbo-pelvic hip complex to prevent bending of the vertebral column and return to balance after perturbation.

Neuromuscular electrical stimulation (NMES) is a technique in which muscle contraction is electrically stimulated in the area where the surface electrodes are connected. It improves secondary muscle atrophy and weakness in immobilization by preventing a decrease in muscle protein synthesis.

Kinesiological banding (CT) is a treatment method used in the treatment of various musculoskeletal and neuromuscular deficits. The mechanism of action of CT is to facilitate muscle activation, increase blood and lymph circulation and reduce pain due to neurological suppression.

Other names: electrical stimulation, kinesiological banding

Primary outcomes

  1. Respiratory Function Tests

    Time frame: 5 min

    Respiratory functions will be measured using portable spirometry.

  2. Muscle Thickness Measurement With Ultrasound

    Time frame: 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.

  3. Maximum inspiratory and expiratory oral pressures

    Time frame: 1 min

    Respiratory muscle strength will be assessed by measuring maximal inspiratory and expiratory pressures.

Secondary outcomes

  1. Brunnstrom Evaluation Scale

    Time frame: 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.

  2. 10 Meter Walk Test

    Time frame: 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.

  3. Trunk Impairment Scale

    Time frame: 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.

  4. Stroke Impact Scale

    Time frame: 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.

  5. Functional Ambulation Scale

    Time frame: 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).

  6. Fatigue Severity Scale

    Time frame: 1 min

    The fatigue severity scale is a 9-item survey that investigated the severity of fatigue in different situations over the past week.

  7. Postural Evaluation Scale for Patients with Stroke

    Time frame: 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.

  8. Peak Cough Flow Rate

    Time frame: 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).

  9. Tinetti Balance Scale

    Time frame: 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.

  10. Timed Up and Go Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effects of Core Stabilization Exercises With Swissball, Neuromuscular Electrical Stimulation and Kinesiology Taping in Stroke Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2021
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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