Clinical trial NCT04777955: The Effects of Core Stabilization Exercises With Swisball in Stroke Patients
Official title: The Effects of Core Stabilization Exercises With Swissball, Neuromuscular Electrical Stimulation and Kinesiology Taping in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Cardiovascular
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1, core stabilization exercises group; Group 2, core stabilization exercises + electrical stimulation group; Group 3, core stabilization exercises + kinesiological banding group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Function Tests
timeFrame: 5 min
measure: Muscle Thickness Measurement With Ultrasound
timeFrame: 10 min
measure: Maximum inspiratory and expiratory oral pressures
timeFrame: 1 min
Secondary outcomes:
measure: Brunnstrom Evaluation Scale
timeFrame: 1 min
measure: 10 Meter Walk Test
timeFrame: 1 min
measure: Trunk Impairment Scale
timeFrame: 5 min
measure: Stroke Impact Scale
timeFrame: 10 min
measure: Functional Ambulation Scale
timeFrame: 1 min
measure: Fatigue Severity Scale
timeFrame: 1 min
measure: Postural Evaluation Scale for Patients with Stroke
timeFrame: 3 min
measure: Peak Cough Flow Rate
timeFrame: 2 min
measure: Tinetti Balance Scale
timeFrame: 5 min
measure: Timed Up and Go Test
timeFrame: 2 min
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Rüstem Mustafaoğlu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jung 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.
citation: Porcari 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.
citation: Lee 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.
citation: Haruyama 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.
citation: Sharma 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.