ClinicalTrials.gg
CompletedNCT03477188Updated Mar 27, 2018

The Effects of Somatosensory and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke.

An interventional study of Somatosensorial and Vestibular Exercises and Conventional Group in Exercise and Acute Stroke, sponsored by Elisa Çalışgan. Completed at 1 site in Turkey. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-03-27.

Primary conditionStrokeRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Stroke
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Elisa Çalışgan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2017, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 484 studies in Stroke with a site in Turkey — 95 open to participants now, 107 under way, 3 of them phase 3. Stroke · Turkey.

Enrollment
130th of 320
44 · median 40
Started
2017
with 9 others
No phase
291 of 484
57 open now
Registered
36th of 484
by date

Among the 484 studies in Stroke with a site in Turkey, this one is the 130th largest by enrollment of the 320 interventional ones that give a count, is one of 10 that started in 2017, is one of 291 with no phase, and was the 36th registered.

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

Browse Stroke studies →

Open to participants now

95 of the 484 studies in Stroke with a site in Turkey are open now. Recruiting first, the newest first:

90 more — sign in →

All 95 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 45 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study summary

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

Read the 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.

03

Conditions studied

  • Exercise
  • Acute Stroke

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Keywords

  • Stroke
  • Vestibular
  • Somatosensory
  • Rehabilitation
  • Balance
04

In context

Stroke Reclassified

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 44 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

This is the only study on the registry with Elisa Çalışgan as lead sponsor.

Compared within Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 will be included in the study.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Somatosensorial and Vestibular Exercises Group

    This group of patients received patients with acute stroke. It will be applied somatosensorial and vestibular rehabilitation additional conventional therapy

    Behavioral: Somatosensorial and Vestibular Exercises

  • Active comparator
    Conventional Group

    This Group patients received patient with acute stroke. It will be applied classical physiotherapy and conventional exercises.

    Behavioral: Conventional Group

Interventions

  • BehavioralSomatosensorial and Vestibular Exercises

    In the experimental group, the subjects who were taken to the somatosensorial and vestibular exercises program after pre- treatment evaluations. The subjects in this group were given classical physiotherapy and somatosensorial combined with vestibular exercise performed 5-7 days a week, 1 set of 10 times with physiotherapist control. In the content of the training, in addition to the general physiotherapy program applied for Brunnstrom and Bobath exercises and spasticity inhibition according to in-bed mobility, Flask and spasticity conditions in the experimental group, a mutual study program was prepared with Cawthorne-Cooksey and Frenkel exercises in the bed, then balance and walking will be performed with the exercises

  • BehavioralConventional Group

    In the control group, The subjects who were taken into the study were taken to the classical physiotherapy based on Bobath and Brunnstrom will be applied to increase the mobilization and spasticity up to the discharge stage known as 5-7 days a week

07

What researchers measure

Primary outcomes

  1. Change from balance (Kore Balance score) of patients with acute stroke at 5-7 days a week.

    It used to measure static standing and dynamic balance ability by assessing posture imbalance, which was recorded as the anterior-to-posterior postural sway and the medial-to-lateral sway for 30 s. Kore Balance System facilitates the performance of a 4-way evaluation of the balance of front/left, front/right, behind/left, and behind/right and calculates total score. The total score, including deviations caused by impairment of postural balance, is calculated by the device. An increase in the total score indicates worse balance; that is, higher total scores indicate poorer balance and lower total scores, better balance . When the static and dynamic balance parameters of the hemiplegic participants were evaluated, the ground instability index was set to 5, with the participants' eyes open and their hands on the device. Our study included Kore Balance which evaluate dynamic and static balance with stroke and pressure of flor is arranged by physical therapist.

    Time frame: 5-7 days a week

Secondary outcomes

  1. Change from control of body (Functional Reach (FRT)Test) of patients with acute stroke.

    It used to measure stabilization of body and the maximal distance one can reach forward beyond arm's length, while maintaining a fixed base of support in the sitting and standing positions. The FRT involves positioning the participant next to a wall with their right or dominant arm raised 90°, adjacent and parallel to a yardstick. With the participant's hand in a fist and feet not lifting or moving, the maximum distance a participant is able to reach forward from an initial upright posture to maximal leaning posture is recorded. The position of the knuckle of the third metacarpophalangeal is recorded. The FRT displaces the participant's centre of gravity and gives a measure of stability and postural control. A reach of less than or equal to 15 cm was found to be predictive of a fall in older patients with acute stroke. FRT scores were categorized as less than 25.4 cm (higher risk of falling), as more than 25.4cm (lower risk of falling).

    Time frame: 5-7 days a week

  2. 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

    It used to measure level of postural control. PASS scale designed to evaluate and observe postural stability and postural control in patients with acute stroke. This scale contains 12 four-level (0,1,2,3) items of modified difficulty for evaluating ability to maintain or change given lying, sitting ot standing posture. A score of 0 on the PASS indicates can not perform, while score of 36 indicates that patients with acute stroke can perform without help.

    Time frame: 5-7 days a week

  3. Change from ambulation (Functional Ambulance Classification (FAS) Scale) of patients with acute stroke at 5-7 days a week.

    It used to measure level of ambulation. Functional Ambulation Scale including nonfunctional(0 point), level 2(1 point), level 1(2 points), controlled dependence (3 points), independence on smooth grade (4 points), independence (5 points). Our patients with acute stroke had high risk of falling so we increase gradually difficulties of exercises and evaluate with FAS. A scores of 0, 1,2 on the FAS indicate can not independence ambulation physically, while scores of 3, 4, 5 indicate can independence ambulation physically.

    Time frame: 5-7 days a week

  4. Visual Analog Scale (VAS)

    It used to measure level of pain.The Visual Analogue Scale (VAS) was used to evaluate the hemiplegic upper and lower extremity pain with activation, resting and night associated with spasticity. A score of 0 on the VAS is defined as no pain and a score of 10 as severe pain .

    Time frame: 5-7 days a week

  5. Change from muscle tone (Modified Ashworth (MASS)Scale) of patients with acute stroke at 5-7 days a week.

    It used to measure muscle tone. The Modified Ashworth Scale (MAS) was used to determine upper and lower extremity spasticity. The MAS uses a five-point scale to score the average resistance to passive movement for each joint. A score of 0 on the MAS indicates no increase in muscle tone, while a score of 4 indicates that the affected part is rigid. MAS scores (0, 1, 1+, 2, 3, and 4) were assigned numerical modified, whereby for example, a score of 1 + was assigned the value of 1.5. Higher total scores indicate higher tone of muscle known as severe.

    Time frame: 5-7 days a week

  6. Change from sensation(Sensory Evaluation) of patients with acute stroke

    It used to measure level of sensation. The sensory examination includes pain sensation (with the pin-prick), light touch sensation( with the brush or cotton wool), cold ( stimulated with cold pack), stereognosis, dysdiadochokinesia and tactile stimulation. The regions of sensory testing were check, arm, hand , trunk, leg, foot. When patients with acute stroke were evaluated sensory system, patients's eyes closed and with the needle and brush at intervals approximately 5 seconds. Sensory examination of affected side comprised with contralateral known as asymptomatic side. Sensory impairment was graded as success and unsuccess.

    Time frame: 5-7 days a week

08

Study locations

1 site
  • Inonu University
    Malatya, 44100, Turkey
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Dec 2017, 2 months.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 2 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2018
First posted
Mar 26, 2018
StartActual
Sep 30, 2017
Primary completionActual
Dec 16, 2017
CompletionActual
Mar 12, 2018
Last update
Mar 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03477188
Lead sponsor
Elisa Çalışgan
Collaborators
Inonu University
Responsible party
Elisa Çalışgan (The Effects of Somatosensorial and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients with Acute Stroke, Inonu University) — Sponsor-investigator
First posted
Mar 26, 2018
Start date
Sep 30, 2017
Primary completion
Dec 16, 2017
Completion
Mar 12, 2018
Last update
Mar 27, 2018

Study contacts

Elisa Çalışgan, MsC
principal investigator · Inonu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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