Stroke
Conditions
Keywords
Stroke, Vestibular Exercise, Fatigue, Balance, Gait
Brief summary
The goal of this clinical trial is to search effects of vestibuler exercises on post-stroke fatigue. The main question it aims to answer is: wer are: \- Do vestibuler excercises decrease post-stroke perceived and physiologic fatigue? Researchers will compare the effects of vestibuler exercises to conventional rehabilitation to find out the superior one. Participants will: * take a one-hour conventional rehabilitation or vestibuler exercise program three times in a week. * be assessed in terms of fatigue before and after rehabilitation programs.
Detailed description
One of the most common complications after stroke is fatigue. Fatigue prolongs the rehabilitation period and delays recovery. Although medical treatments, exercise programs and activity modifications are recommended to reduce fatigue after stroke, an effective evidence-based treatment method has not yet been developed. Vestibular exercises can improve oculomotor and postural control by trying to provide sensory integration through adaptation and compensatory mechanisms, thus increasing cortical excitability and reducing fatigue.
Interventions
OTHERControl (Standard treatment)
In control group participants will take one hour conventional physiotherapy including stretching, strengthening, balance and gait exercises in each session.
OTHERVestibular exercise
In vestibular group (study group) participant will take 40 minutes conventional physiotherapy including stretching, strengthening, balance and gait exercises, and 20 minutes vestibular exercises including head and gaze stabilization, occulomotor, head turning and balance exercises in different postures.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Volunteering to participate in the study Being between the ages of 18-65 Having had an anterior circulation stroke at least 6 months ago Being at least stage 3 according to the Functional Ambulation Classification Scoring at least 22 on the Montreal Cognitive Assessment Scale
Exclusion criteria
* Having another orthopedic, neurological or other systemic disease that prevents working Having severe aphasia Having a disease other than stroke that causes primary fatigue Using medication that will affect cognitive status Using medication that will affect fatigue
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Fatigue Assessment Scale | One week before rehabilitation program and one week after rehabilitation program. | The Fatigue Assessment Scale (FAS) consists of 10 items. Responses are given on a five-point Likert scale, with 1 for never and 5 for always. The FAS asks participants to rate how they feel on a daily basis. |
| Fatigue Impact Scale | One week before rehabilitation program and one week after rehabilitation program. | The Fatigue Impact Scale (FIS) will be used. The FIS, which provides information on the presence and severity of fatigue, asks patients to evaluate 10 physical, 10 cognitive, and 20 psychosocial function-related statements within the scope of their fatigue levels in the last month. Each statement can take a value between 0 and 4. 0 indicates no problem, while 4 indicates the most severe problem. The total scale score varies between 0 and 160. A higher score indicates that the effect of fatigue is greater. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six Minutes Walking Test | One week before rehabilitation program and one week after rehabilitation program. | The assessment of physiological fatigue will be made by calculating the time-dependent change in walking distance with the ambulatory walking index as a result of the 6-minute walking test (6MWT). At the beginning of the test, participants will be instructed to complete as much distance as possible, aiming to complete at the highest speed. The distances walked per minute and the total distance will be recorded and expressed in meters. In order to measure the decrease in the distance walked from the first minute to all other minutes of the 6-minute walking test, the percentage change in the distance walked will be calculated starting from the second minute. Objective measurement of fatigue will be made by decreasing walking distance between 1 and 6 minutes. |
| Symbol Digit Modalities Test | One week before rehabilitation program and one week after rehabilitation program. | Physiological mental fatigue will be assessed with the Symbol Digit Modalities Test (SDMT). In the test, 9 numbers are represented by 9 symbols. In the test, participants will be asked to match the symbols given in a mixed manner with the numbers for a period of 180 seconds by looking at the guide. The number of correct answers will be recorded 6 times, every 30 seconds. The difference between the cognitive fatigue value 1. Score and 6. Score will be recorded as the fatigue value. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bertec Force Plate (Balance Check Screener™ BP5050 20x20´´ Bertec Comporation Columbus, OH, USA) | One week before rehabilitation program and one week after rehabilitation program. | Bertec force plate (Balance Check Screener™ BP5050 20x20´´ Bertec Comporation Columbus, OH, USA) is a three-component balance platform that is based on objectively measuring instantaneous changes in vertical force and pressure center. It consists of a total of 5 tests, including tests for 4 different situations in static stance and a test that includes stability limits. The participant is asked to wait 10 seconds without moving in each situation with eyes open and eyes closed on hard and soft ground. Oscillations are recorded by the device for evaluation during the test. |
| The GAITRite Gait Analysis System (CIR Systems Inc., Franklin, New Jersey, USA) | One week before rehabilitation program and one week after rehabilitation program. | The GAITRite Gait Analysis System (CIR Systems Inc., Franklin, New Jersey, USA) will be used to evaluate the participants' gait cycle time, gait speed (cm/s), cadence (step/min), step length (cm), double step length (cm), step width (cm), foot angle (°), support surface (cm), single leg stance time (%GC), and time-distance characteristics of individuals' gait, such as plantar pressure distributions, while they walk at their own pace. The GAITRite system is considered the gold standard in the evaluation of time-distance characteristics of gait (29). The participants' walks will be repeated 3 times and the average of the data related to the gait will be used in the analyses |
| Functional Gait Assessment | One week before rehabilitation program and one week after rehabilitation program. | Walking performance and functionality will be assessed with the Functional Gait Assessment (FGA). The FGA is an ambulation-based balance test initially proposed to assess higher-level balance in individuals with vestibular disorders. Although it was developed for use in patients with vestibular pathologies, it has since been used as an outcome measure in a variety of patient populations. The FGA was developed as a modification of the dynamic gait index to increase reliability and reduce the ceiling effect commonly seen with the DGI, with three items added to the 7 items of the dynamic gait index: walking with narrow-based support, walking backward, and walking with eyes closed. Each of the 10 items in the FGA is scored from 0 to 3, with a best score of 30. Validity and reliability have been demonstrated in stroke patients |
| Fugl Meyer Assessment | One week before rehabilitation program and one week after rehabilitation program. | Motor functionality will be assessed with the Fugl Meyer Upper Extremity (FMA-UE) and Fugl Meyer Lower Extremity (FMA-LE) scales. FMA-UE is a frequently used assessment tool to assess motor recovery of the upper extremity after stroke. Scoring is as follows; 0= cannot perform, 1= partially perform, 2= fully perform. The total score for upper extremity motor function is 66. FMA-LE is a disease-specific impairment assessment designed to assess motor function, balance, sensory qualities, and joint function in patients after stroke. Scoring is as follows; 0= cannot perform, 1= partially perform, 2= fully perform. |
| Fullerton Advanced Balance Scale | One week before rehabilitation program and one week after rehabilitation program. | Fullerton Advanced Balance Scale is a scale developed to evaluate small changes in balance in multiple ways. The highest score that can be obtained from the scale consisting of 10 items scored between 0 and 4 is 40. FAB is a scale that can be applied quickly (∼10-12 min) and does not require space. Its validity and reliability have been shown in stroke patients, and the cut-off score has been determined as 21.5. |
| Timed Up and Go Test | One week before rehabilitation program and one week after rehabilitation program. | Timed Up and Go Test; verbal instructions are given to the patient, and the patient is asked to get up from the chair, walk 3 meters as quickly and safely as possible following a line marked on the floor, turn, walk back and sit down. 10 seconds and below; the patient walks independently, the risk of falling is very low. 11-19 seconds; the patient walks independently, the risk of falling is low to moderate. 20-29 seconds; the patient may need help from time to time, the risk of falling is moderate to high. Over 30 seconds, the risk of falling is high and the need for help from time to time |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAyla Fil Balkan, Assoc Prof
Outcome results
None listed