Core Stabilization Exercises in Stroke

NCT ID: NCT04673123

Last Updated: 2022-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-11

Study Completion Date

2022-03-16

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Core Stabilization Group

Core stabilization + Multifactorial Education Program (patient-specific upper and lower extremity stretching and strengthening exercises; application of functional electrical stimulation (FES) to upper and lower extremity muscles; balance, coordination and gait training)+ Informing about fall prevention (by verbal and written)

Group Type EXPERIMENTAL

Core stabilization exercises

Intervention Type OTHER

In our study, core stabilization exercises to be applied in the intervention group are arranged according to the patients with stroke and will be at three different difficulty levels. Exercises will be done on the back (hooked) and sitting positions where the risk of falling is low. First of all, activation of the "transversus abdominis" muscle, which is the basis of core stabilization, will be taught to patients. With this activation at the first level, the healthy side, at the second level the affected side, and at the third level, reciprocal upper and lower extremity movements will be requested. In addition to these, there will be exercises to bridge and curl up in supine position, and weight transfer in sitting position. In order to increase the difficulty level of the exercises, first of all, the number of exercises will be increased and then it will be asked to move on to the next level.

Multifactorial Education Program

Intervention Type OTHER

The content of this program includes 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, and strengthening exercises; application of functional electrical stimulation (FES) to upper and lower extremity muscles; balance, coordination and gait training are included. he content of multifactorial fall prevention training includes the first brochure titled '' General Recommendations for the Prevention of Fall in Chronic Stroke Patients '', which will include general recommendations for preventing falling according to the fall risk factors specific to the stroke, and the recommendations to minimize the risk of falling in the home. A second brochure titled 'Suggestions for Making Your Home Safer' will be given. The information in these brochures will also be communicated to patients face to face verbally

Multifactorial Education Program Group

Multifactorial Education Program (patient-specific upper and lower extremity stretching, relaxation and strengthening exercises; application of functional electrical stimulation (FES) to upper and lower extremity muscles; balance, coordination and gait training)+ Informing about fall prevention (by verbal and written)

Group Type ACTIVE_COMPARATOR

Multifactorial Education Program

Intervention Type OTHER

The content of this program includes 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, and strengthening exercises; application of functional electrical stimulation (FES) to upper and lower extremity muscles; balance, coordination and gait training are included. he content of multifactorial fall prevention training includes the first brochure titled '' General Recommendations for the Prevention of Fall in Chronic Stroke Patients '', which will include general recommendations for preventing falling according to the fall risk factors specific to the stroke, and the recommendations to minimize the risk of falling in the home. A second brochure titled 'Suggestions for Making Your Home Safer' will be given. The information in these brochures will also be communicated to patients face to face verbally

Interventions

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Core stabilization exercises

In our study, core stabilization exercises to be applied in the intervention group are arranged according to the patients with stroke and will be at three different difficulty levels. Exercises will be done on the back (hooked) and sitting positions where the risk of falling is low. First of all, activation of the "transversus abdominis" muscle, which is the basis of core stabilization, will be taught to patients. With this activation at the first level, the healthy side, at the second level the affected side, and at the third level, reciprocal upper and lower extremity movements will be requested. In addition to these, there will be exercises to bridge and curl up in supine position, and weight transfer in sitting position. In order to increase the difficulty level of the exercises, first of all, the number of exercises will be increased and then it will be asked to move on to the next level.

Intervention Type OTHER

Multifactorial Education Program

The content of this program includes 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, and strengthening exercises; application of functional electrical stimulation (FES) to upper and lower extremity muscles; balance, coordination and gait training are included. he content of multifactorial fall prevention training includes the first brochure titled '' General Recommendations for the Prevention of Fall in Chronic Stroke Patients '', which will include general recommendations for preventing falling according to the fall risk factors specific to the stroke, and the recommendations to minimize the risk of falling in the home. A second brochure titled 'Suggestions for Making Your Home Safer' will be given. The information in these brochures will also be communicated to patients face to face verbally

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Aslıhan Kırktepeli

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aslıhan Kırktepeli

Role: PRINCIPAL_INVESTIGATOR

Istanbul University- Cerrahpasa /Institute of Postgraduate Education

İpek Yeldan

Role: STUDY_CHAIR

Istanbul University- Cerrahpasa / Faculty of Health Science

Locations

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Bursa Ilker Celikcan Physical Therapy and Rehabilitation Hospital

Bursa, Osmangazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Batchelor FA, Mackintosh SF, Said CM, Hill KD. Falls after stroke. Int J Stroke. 2012 Aug;7(6):482-90. doi: 10.1111/j.1747-4949.2012.00796.x. Epub 2012 Apr 12.

Reference Type BACKGROUND
PMID: 22494388 (View on PubMed)

Xu T, Clemson L, O'Loughlin K, Lannin NA, Dean C, Koh G. Risk Factors for Falls in Community Stroke Survivors: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Mar;99(3):563-573.e5. doi: 10.1016/j.apmr.2017.06.032. Epub 2017 Aug 7.

Reference Type BACKGROUND
PMID: 28797618 (View on PubMed)

Schinkel-Ivy A, Inness EL, Mansfield A. Relationships between fear of falling, balance confidence, and control of balance, gait, and reactive stepping in individuals with sub-acute stroke. Gait Posture. 2016 Jan;43:154-9. doi: 10.1016/j.gaitpost.2015.09.015. Epub 2015 Sep 28.

Reference Type BACKGROUND
PMID: 26482234 (View on PubMed)

Batchelor F, Hill K, Mackintosh S, Said C. What works in falls prevention after stroke?: a systematic review and meta-analysis. Stroke. 2010 Aug;41(8):1715-22. doi: 10.1161/STROKEAHA.109.570390. Epub 2010 Jul 8.

Reference Type BACKGROUND
PMID: 20616328 (View on PubMed)

Quigley PA. Redesigned Fall and Injury Management of Patients With Stroke. Stroke. 2016 Jun;47(6):e92-4. doi: 10.1161/STROKEAHA.116.012094. Epub 2016 Apr 26. No abstract available.

Reference Type BACKGROUND
PMID: 27118792 (View on PubMed)

Verheyden GS, Weerdesteyn V, Pickering RM, Kunkel D, Lennon S, Geurts AC, Ashburn A. Interventions for preventing falls in people after stroke. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD008728. doi: 10.1002/14651858.CD008728.pub2.

Reference Type BACKGROUND
PMID: 23728680 (View on PubMed)

Haruyama K, Kawakami M, Otsuka T. Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients. Neurorehabil Neural Repair. 2017 Mar;31(3):240-249. doi: 10.1177/1545968316675431. Epub 2016 Nov 9.

Reference Type BACKGROUND
PMID: 27821673 (View on PubMed)

Willson JD, Dougherty CP, Ireland ML, Davis IM. Core stability and its relationship to lower extremity function and injury. J Am Acad Orthop Surg. 2005 Sep;13(5):316-25. doi: 10.5435/00124635-200509000-00005.

Reference Type BACKGROUND
PMID: 16148357 (View on PubMed)

Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8.

Reference Type BACKGROUND
PMID: 26451007 (View on PubMed)

Jung Y, Lee K, Shin S, Lee W. Effects of a multifactorial fall prevention program on balance, gait, and fear of falling in post-stroke inpatients. J Phys Ther Sci. 2015 Jun;27(6):1865-8. doi: 10.1589/jpts.27.1865. Epub 2015 Jun 30.

Reference Type BACKGROUND
PMID: 26180337 (View on PubMed)

Batchelor FA, Hill KD, Mackintosh SF, Said CM, Whitehead CH. Effects of a multifactorial falls prevention program for people with stroke returning home after rehabilitation: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Sep;93(9):1648-55. doi: 10.1016/j.apmr.2012.03.031. Epub 2012 Apr 10.

Reference Type BACKGROUND
PMID: 22503739 (View on PubMed)

Vahlberg B, Cederholm T, Lindmark B, Zetterberg L, Hellstrom K. Short-term and long-term effects of a progressive resistance and balance exercise program in individuals with chronic stroke: a randomized controlled trial. Disabil Rehabil. 2017 Aug;39(16):1615-1622. doi: 10.1080/09638288.2016.1206631. Epub 2016 Jul 14.

Reference Type BACKGROUND
PMID: 27415645 (View on PubMed)

Lindsay P, Furie KL, Davis SM, Donnan GA, Norrving B. World Stroke Organization global stroke services guidelines and action plan. Int J Stroke. 2014 Oct;9 Suppl A100:4-13. doi: 10.1111/ijs.12371. Epub 2014 Sep 23.

Reference Type BACKGROUND
PMID: 25250836 (View on PubMed)

Kwong PWH, Ng SSM. Cutoff Score of the Lower-Extremity Motor Subscale of Fugl-Meyer Assessment in Chronic Stroke Survivors: A Cross-Sectional Study. Arch Phys Med Rehabil. 2019 Sep;100(9):1782-1787. doi: 10.1016/j.apmr.2019.01.027. Epub 2019 Mar 20.

Reference Type BACKGROUND
PMID: 30902629 (View on PubMed)

Mong Y, Teo TW, Ng SS. 5-repetition sit-to-stand test in subjects with chronic stroke: reliability and validity. Arch Phys Med Rehabil. 2010 Mar;91(3):407-13. doi: 10.1016/j.apmr.2009.10.030.

Reference Type BACKGROUND
PMID: 20298832 (View on PubMed)

Goh EY, Chua SY, Hong SJ, Ng SS. Reliability and concurrent validity of Four Square Step Test scores in subjects with chronic stroke: a pilot study. Arch Phys Med Rehabil. 2013 Jul;94(7):1306-11. doi: 10.1016/j.apmr.2013.01.027. Epub 2013 Feb 12.

Reference Type BACKGROUND
PMID: 23416218 (View on PubMed)

Chan PP, Si Tou JI, Tse MM, Ng SS. Reliability and Validity of the Timed Up and Go Test With a Motor Task in People With Chronic Stroke. Arch Phys Med Rehabil. 2017 Nov;98(11):2213-2220. doi: 10.1016/j.apmr.2017.03.008. Epub 2017 Apr 7.

Reference Type BACKGROUND
PMID: 28392324 (View on PubMed)

Flansbjer UB, Blom J, Brogardh C. The reproducibility of Berg Balance Scale and the Single-leg Stance in chronic stroke and the relationship between the two tests. PM R. 2012 Mar;4(3):165-70. doi: 10.1016/j.pmrj.2011.11.004. Epub 2012 Feb 3.

Reference Type BACKGROUND
PMID: 22306324 (View on PubMed)

Related Links

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https://iopscience.iop.org/article/10.1088/1742-6596/1358/1/012025/pdf

The effects of comprehensive core body resistance exercise on lower extremity motor function among stroke survivors

http://geriatri.dergisi.org/abstract.php?id=811

The Turkish version of the Activities Specific Balance Confidence (ABC) Scale: its cultural adaptation, validation and reliability in older adults

Other Identifiers

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2021-10/40

Identifier Type: -

Identifier Source: org_study_id

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