The Effects of Somatosensory and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke.
Assessment Effects of Somatosensorial and Vestibular Rehabilitation Additional Conventional Therapy on Balance in Patients With Acute Stroke
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Malatya, Turkey, 44100
- Inonu University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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
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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
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ACTIVE_COMPARATOR: Conventional Group
This Group patients received patient with acute stroke.
It will be applied classical physiotherapy and conventional exercises.
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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
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from balance (Kore Balance score) of patients with acute stroke at 5-7 days a week.
Time Frame: 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.
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5-7 days a week
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from control of body (Functional Reach (FRT)Test) of patients with acute stroke.
Time Frame: 5-7 days a week
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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).
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5-7 days a week
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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
Time Frame: 5-7 days a week
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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.
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5-7 days a week
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Change from ambulation (Functional Ambulance Classification (FAS) Scale) of patients with acute stroke at 5-7 days a week.
Time Frame: 5-7 days a week
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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.
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5-7 days a week
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Visual Analog Scale (VAS)
Time Frame: 5-7 days a week
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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 .
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5-7 days a week
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Change from muscle tone (Modified Ashworth (MASS)Scale) of patients with acute stroke at 5-7 days a week.
Time Frame: 5-7 days a week
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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.
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5-7 days a week
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Change from sensation(Sensory Evaluation) of patients with acute stroke
Time Frame: 5-7 days a week
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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.
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5-7 days a week
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Elisa Çalışgan, MsC, Inonu University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2017/97
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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