Clinical trial NCT04673123: Core Stabilization Exercises in Stroke
Official title: The Effects of Core Stabilization Exercises on Fall, Lower Limb Function, and Balance in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Falling
Fall
Core stabilization
Core exercising
Cerebrovascular Accident
Fall prevention
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is one of the leading causes of disability and death worldwide. Falling is defined as a person accidentally lying on a floor or another low level with or without injury. In patients with stroke occur motor, sensory, functional and cognitive disorders which are increased the rate of falls after stroke. Physiological and psychological complications that occur as a result of a fall are exhausting for both the patient and the therapist. Because while the patients regress physiologically even more, the 'fear of falling again', which occurs with falling, reduces the patient's participation in rehabilitation.When looking at the risk factors determined for falls in stroke patients, reduced mobility and impaired balance functions are in the first place and that is evidenced with most of falls occur during walking and transfers the most frequent.The main reason of affected mobility is the weakness in the deep trunk muscles and insufficient stability, except for the loss of strength in the affected lower extremity. In the literature, it is stated that having strong core muscles can contribute to the efficient use of the lower extremity. According to the previous studies, applied stabilization exercises in addition to traditional rehabilitation improve the balance and mobility functions of patients with subacute stroke. However, there is not enough information about the benefits of these exercises in patients with chronic stroke. Most falls occur at home specially in the bedroom and bathroom in patients with stroke. This indicates that environmental factors should be taken into consideration in the rehabilitation program besides physical factors, that is, a "multifactorial falls prevention program" should be implemented. Based on these information, the aim of our study is to investigate the benefits of core stabilization exercises which is included in a multifactorial training on falling number, fear of falling, lower extremity function and balance in patients with chronic stroke who have a history of falling.

Detailed description: The volunteers to be included in our study will be selected from chronic stroke patients who are receiving physical therapy at Bursa İlker Çelikcan Physical Therapy and Rehabilitation Hospital and have a history of falling. The study will consist of two separate groups, core stabilization and multifactorial education group. Patients who suitable the inclusion criteria will be randomized according to the order of initiation of the physical therapy program in the hospital and divided into groups. Both groups will participate in a multifactorial education program. In this program program, there are physical therapy and rehabilitation practices that are routinely applied in stroke rehabilitation and that patients will receive at the specified hospital. In the content of these applications; patient-specific upper and lower extremity stretching, relaxation and strengthening exercises; balance, coordination and gait training are included.In addition to these, patients in the intervention group will perform core stabilization exercises under the supervision of a physiotherapist. The exercises will be applied 5 times a week for 6 weeks. First of all, activation of the "transversus abdominis" muscle, which forms the basis of core stabilization, will be taught to patients. "Chattanooga Stabilizer Pressure Biofeedback Device" will be used in order to teach this activation and to observe whether the patient is doing it correctly during exercises. The exercises will be made more difficult by adding extremity movements to this activation. Evaluations will be made twice, at the beginning (0. week) and end of the treatment (13. week).In order to evaluate the effect of the treatment on the fall, the number of falls that occurred within 3 months after the end of the treatment will be questioned by phone.

Eligibility criteria: Inclusion Criteria:

* Being a volunteer
* Between 45-75 years old
* Stroke onset time is 6 months or more
* Not having botox application to lower extremity muscles in the last 3 months
* At least has one history of falling in the last 6 months
* At least has 3 and above level according to the Functional Ambulation Scale

Exclusion Criteria:

* Unstable medical condition
* Presence of rheumatological, orthopedic or pulmonary disease at a level that prevents participation in exercise
* Hearing and vision loss at a level that prevents communication
* Operation due to low back pain
* Not understanding Turkish verbal and written instructions

Primary outcomes:
measure: Number of falls
timeFrame: The number of falls will be questioned following three months after the treatment program completed.
Secondary outcomes:
measure: The Activities-Specific Balance Confidence (ABC) Scale
timeFrame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
measure: Fugl Meyer Assessment Lower Extremity (FMA-LE)
timeFrame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
measure: The Five Times Sit-to-Stand Test
timeFrame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
measure: The Four Square Step Test (FSST)
timeFrame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
measure: The Modified Kraus-Weber Test
timeFrame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
measure: Berg Balance Scale
timeFrame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment.
measure: The Single Leg Stance Test
timeFrame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
measure: Timed Up and Go Test
timeFrame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Ilker Celikcan Physical Therapy and Rehabilitation Hospital
state: Osmangazi
Study officials:
affiliation: Istanbul University- Cerrahpasa /Institute of Postgraduate Education
name: Aslıhan Kırktepeli
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University- Cerrahpasa / Faculty of Health Science
name: İpek Yeldan
role: STUDY_CHAIR
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