The Effects of Core Stabilization Exercises With Swisball in Stroke Patients
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2021
CompletedFirst Posted
Study publicly available on registry
March 2, 2021
CompletedStudy Start
First participant enrolled
May 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedAugust 29, 2022
August 1, 2022
1 year
March 1, 2021
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Respiratory Function Tests
Respiratory functions will be measured using portable spirometry.
5 min
Muscle Thickness Measurement With Ultrasound
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.
10 min
Maximum inspiratory and expiratory oral pressures
Respiratory muscle strength will be assessed by measuring maximal inspiratory and expiratory pressures.
1 min
Secondary Outcomes (10)
Brunnstrom Evaluation Scale
1 min
10 Meter Walk Test
1 min
Trunk Impairment Scale
5 min
Stroke Impact Scale
10 min
Functional Ambulation Scale
1 min
- +5 more secondary outcomes
Study Arms (3)
Group 1, core stabilization exercises group
EXPERIMENTALcore stabilization exercises will be performed using swissball. Program: Sitting on the ball will include (weight shifts, forward, backward and lateral sides), (pelvic bridge), (curl-up), (curlsup with diagonal reaching), (bird-dog exercise), (push-up) exercises. The application will be carried out for 6 weeks, 3 days a week for 30-45 minutes daily.
Group 2, electrical stimulation
EXPERIMENTALAn adaptation of a pre-designed protocol will be used for the application of the Normocular Electrical Stimulation in the diaphragm. Current to be applied; Synchronous impulse at 30 Hz frequency, 1 sec beat increase time, 1 sec "on" (muscle contraction), 1 sec beat reduction time and 20 sec "off" (no warning) time. Two channels, each with two electrodes, will be placed in the seventh and eighth anterior intercostal space above and below the right and left sides of the xiphoid protrusion. The other two channels, each with two electrodes, will be placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space. The application will be carried out for 6 weeks, 3 days a week, for 30 minutes daily.
group 3, kinesiotape
EXPERIMENTALFor anterior diaphragm banding, the patient will stand with arms raised. Next, the central part of the tape will be applied to the xiphoid protrusion with a tension of 50% to 70% after the maximum inhalation. While the patient is breathing, the ends of the tape will be pulled with 10 to 15% tension towards the lower ribs. To tape the rear diaphragm, the patient's body will bend forward, and the arms will be joined crosswise over the chest. After the maximum inhalation, the central part of the tape will be applied over the T10 with a tension of 50% to 70%. As the patient exhales and stretches the trunk, the ends of the tape will be attached to the lower ribs with a tension of 10 to 15%. The supine position will be used in the Kinesiological taping of the right and left external oblique and internal oblique muscles. The application will be carried out for 6 weeks, 3 days a week, for 30 minutes daily.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Neurological disorders other than stroke that could potentially affect balance and ambulation;
- Body failure scale score below 10 points
- Apraxia and hemineglect
- years and older
- Orthopedic disorders or rib fracture
- Patients with neglect syndrome
- A history of seizures or a family history of epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University Cerrahpasa
Istanbul, 34147, Turkey (Türkiye)
Related Publications (6)
Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.
PMID: 28284044RESULTJung JH, Kim NS. The correlation between diaphragm thickness, diaphragmatic excursion, and pulmonary function in patients with chronic stroke. J Phys Ther Sci. 2017 Dec;29(12):2176-2179. doi: 10.1589/jpts.29.2176. Epub 2017 Dec 13.
PMID: 29643599RESULTPorcari JP, Miller J, Cornwell K, Foster C, Gibson M, McLean K, Kernozek T. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance, and selected anthropometric measures. J Sports Sci Med. 2005 Mar 1;4(1):66-75. eCollection 2005 Mar 1.
PMID: 24431963RESULTLee J, Jeon J, Lee D, Hong J, Yu J, Kim J. Effect of trunk stabilization exercise on abdominal muscle thickness, balance and gait abilities of patients with hemiplegic stroke: A randomized controlled trial. NeuroRehabilitation. 2020;47(4):435-442. doi: 10.3233/NRE-203133.
PMID: 33136074RESULTHaruyama K, Kawakami M, Otsuka T. Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients. Neurorehabil Neural Repair. 2017 Mar;31(3):240-249. doi: 10.1177/1545968316675431. Epub 2016 Nov 9.
PMID: 27821673RESULTSharma V, Kaur J. Effect of core strengthening with pelvic proprioceptive neuromuscular facilitation on trunk, balance, gait, and function in chronic stroke. J Exerc Rehabil. 2017 Apr 30;13(2):200-205. doi: 10.12965/jer.1734892.446. eCollection 2017 Apr.
PMID: 28503533RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rüstem Mustafaoğlu
Istanbul University - Cerrahpasa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- closed envelope procedure
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- specialist physiotherapist
Study Record Dates
First Submitted
March 1, 2021
First Posted
March 2, 2021
Study Start
May 4, 2021
Primary Completion
May 8, 2022
Study Completion
June 1, 2022
Last Updated
August 29, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share