Clinical trial NCT03477188: The Effects of Somatosensory and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke.
Official title: Assessment Effects of Somatosensorial and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Acute Stroke
Keywords: Stroke
Vestibular
Somatosensory
Rehabilitation
Balance
Lead sponsor: Inonu University
Sponsor class: OTHER
Collaborators: name: Inonu University
First posted: 2018-03-26
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, Randomized Controlled Study
Primary purpose: TREATMENT

Brief summary: This study was planned to evaluate the effects of somatosensory and vestibular rehabilitation additional conventional therapy on balance in patients with acute stroke.

Detailed description: Stroke or unsufficient cerebral circulation is a non-traumatic disease due to occlusion or rupture of brain blood circulation characterized by neurological deficits such as loss of motor control, cognitive impairment, oral disorder or sensory changes in one half of the body resulting from changes. The resulting hemiplegia in the stroke result in half of the body's neuromuscular vascular syndrome characterized by impairment. The largest stroke classification that currently holds validity is based on etiology by the National Institutes of Health Stroke Scale (NIHSS). The stroke is due to ischemic and hemorrhagic disorder. Ischemic stroke results in the formation of thrombosis (40%), emboli (30%) and lacunar infections (20%). Increased intracranial pressure in the haemorrhage results in increased load on the vessel, which causes the wall to rupture. The blood is then poured into the brain tissue and forms 10% of all the stomachs. In the anterior circulation, the anterior carotid interna, the anterior cerebri media and the cerebri anterior are affected. In the posterior circulation a.vertebralis, a.basillaris and a. cerebri posterior is affected. Eighty percent of patients have a carotid system lesion and affect the cerebral hemispheres and cause hemiplegia. Cardiac-derived emboli migrate more towards the middle cerebral artery. The brain stem-fed system is posterior circulation and although there is better posterior circulation Cerebro Vascular Damage (CVD) prognosis, the presence of vital sites such as respiration and cardiac increases vital danger. The clinical findings of the lesion of the middle cerebral artery show marked contralateral hemialgia, astereognosis, agnosia, alexia, hemianopsia, extremity kinetic apraxia in the upper extremity. The anterior cerebral artery lesion has marked contralateral hemiplegia, grip and sucking reflexes, amnesia, echolalia and urinary incontinence in the lower extremity. Bilateral homonomous hemianopsia, ocular failure is seen in the posterior artery peripheral field lesion, paralysis in vertical eye movements, postural tremor and hemiballismus are seen in the central lesion. Contralateral hemiplegia due to internal carotid artery lesion, aphasia occurs. Coma and quadriplegia are seen due to basilar artery involvement. Anterior superior cerebellar artery involvement, especially lower extremity vibration, decreased position sensation, horizontal nystagmus, contralateral Horner syndrome are seen. Facial paralysis on the same side due to inferior cerebellar artery involvement, decreased pain and temperature on the opposite side, tinnitus and ataxia are seen anteriorly. In vertebral artery involvement, decrease in pain and heat sensation on opposite side, facial hemianesthesia on the same side, tactile and proprioceptive sensory loss, ptosis are seen. In general, visual, proprioceptive and vestibular loss is observed in stroke patients. There is an associated loss of balance which increases the patient's risk of falling. The aim of the patient is to prevent progression of the deformity and complications, correction of the deformity and preservation of the obtained correction.To determine the type of stroke, Computerized Tomography (CT) should be taken within the first 30 minutes of stroke. Imaging of lacunar infections and vertebro basilar arterial infections after 12 hours of (Computerized Brain Tomography) CBT is also unsuccessful. In this case MRI (Magnetic Resonance Imaging) should be withdrawn. In patients with suspected subarachnoid haemorrhage, digital subtraction angiography (DSA) should be performed for patients with lumbar puncture, candidates for carotid endarterectomy, Transesophageal Echocardiography (ECHO) for patients with embolism, and Holter monitoring test if paroxysmal atrial fibrillation or other arrhythmias are considered. A lot of static and dynamic testing and ability of gait record with used by physical therapists such as standing in the romberg position on only foot with open after closed eyes for difficulties of exercises gradually. If clinicians want to reinforce of the force, they can change the surface of support tasks gradually, eyes open or closed, combined head or arm movement to maintain of postural stability excessively, increased step and sway. Similar with our device for evaluation of balance known as clinical test of sensory integration and balance. It consists of 4 different conditions open/closed eyes and firm/compliant surface progressively difficulties. Patients need to stand on the ground for up to 30 seconds on these stance positions. Our study included Kore Balance which evaluate dynamic and static balance with stroke and pressure of flor is arranged by physical therapist in order to test patient's ability to somatosensorial, vestibular and visual stimulation for postural control. Stroke treatment has primary and secondary prevention strategies. Conservative treatment includes physical exercises, orthosis, electrical stimulation, manipulation, and physiotherapy. Some of these treatments have insufficient evidence. It is said that electrical stimulation is not effective in reducing thrombosis and reducing dizziness and headache. There is evidence of increased interest and efficacy in the literature in terms of exercises. The efficacy of Johnstone splint therapy has been proven in studies. It is also part of the treatment of mandatory use therapy, pressure faradism, mirror therapy, Bobath weight transfer, active assistive manipulation of in-bed ROM (Range of Motion) movements, interventional brain stimulation, serotonin reuptake inhibitor drugs. Apart from surgery, Johnstone plays a major role in the treatment of the PNF (Proprioceptive Neuromuscular Facilitation) method, in which feedback from the motor learning program is crucial to Brunnstrom, abdominal contractions become apparent, and maximal resistance is activated by force propagation on the plegia side. The neurophysiologic approach provides proprioceptive, spatial and sensorial sensory enhancement with traction and approximation, and posture reflex is removed. In the Brunnstrom method, motor synergies (flexor and extensor synergy) are first created by using pathological reflexes, then these synergies are used together with antagonist synergists and disintegrated to normal motion. Mainly Cawthorne-Cooksey and Frenkel exercises based on visual, vestibular and proprioceptive senses. Early movements after stroke, we were aimed to present compensatory behaviors, neglect syndrome and fear of falling. Also, vestibular and somatosensorial exercises improved vestibulospinal compensation and provided postural stability. Main purpose of this study is that the effects of somatosensory and vestibular rehabilitation additional conventional therapy on balance in patients with acute stroke.

Eligibility criteria: Inclusion Criteria:

* Inönü University Faculty of Medicine Neurology Department of patients with ischemic or hemorrhagic stroke diagnosed by department,
* Co-operative,
* In the age range 45-80,
* Will be able to adapt to the exercise program,
* To be involved in voluntary work,
* Individuals who have been given their informed consent will be included in the study.

Exclusion Criteria:

* Having incomplete infarction,
* Having symptomatic lesions (abcess, tumor) with excessive bleeding risk or stroke,
* Pulmonary complication,
* If the training does not fit such as confusion or coma,
* Patients with acute stroke who do not want to be involved in voluntary work will not be included.

Primary outcomes:
measure: Change from balance (Kore Balance score) of patients with acute stroke at 5-7 days a week.
timeFrame: 5-7 days a week
Secondary outcomes:
measure: Change from control of body (Functional Reach (FRT)Test) of patients with acute stroke.
timeFrame: 5-7 days a week
measure: Change from postural stability and control PASS (Postural Assessment Scale for Stroke) Rating Scale) of patients with acute stroke at 5-7 days a week
timeFrame: 5-7 days a week
measure: Change from ambulation (Functional Ambulance Classification (FAS) Scale) of patients with acute stroke at 5-7 days a week.
timeFrame: 5-7 days a week
measure: Visual Analog Scale (VAS)
timeFrame: 5-7 days a week
measure: Change from muscle tone (Modified Ashworth (MASS)Scale) of patients with acute stroke at 5-7 days a week.
timeFrame: 5-7 days a week
measure: Change from sensation(Sensory Evaluation) of patients with acute stroke
timeFrame: 5-7 days a week
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: Elisa Çalışgan, MsC
role: PRINCIPAL_INVESTIGATOR
References: