Core Stabilization Exercises in Stroke

NCT04673123 | Completed

• 1 other identifier: 2021-10/40
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Falling; Fall; Core stabilization; Core exercising; Cerebrovascular Accident; Fall prevention

Outcome Measures

Primary Outcomes (1)

• Number of falls

  A chart will be prepared so that patients can record any falls and the patient will be asked to indicate the date of the fall on this chart.The total falling numbers of the two groups will be compared.

  The number of falls will be questioned following three months after the treatment program completed.

Secondary Outcomes (8)

• The Activities-Specific Balance Confidence (ABC) Scale

  It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.

• Fugl Meyer Assessment Lower Extremity (FMA-LE)

  It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.

• The Five Times Sit-to-Stand Test

  It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.

• The Four Square Step Test (FSST)

  It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.

• The Modified Kraus-Weber Test

  It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.

Study Arms (2)

Core Stabilization Group

EXPERIMENTAL

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)

Other: Core stabilization exercises; Other: Multifactorial Education Program

Multifactorial Education Program Group

ACTIVE COMPARATOR

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)

Other: Multifactorial Education Program

Interventions

Core stabilization exercises 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.

Core Stabilization Group

Multifactorial Education Program 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

Core Stabilization Group; Multifactorial Education Program Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Bursa Ilker Celikcan Physical Therapy and Rehabilitation Hospital

Bursa, Osmangazi, 16170, Turkey (Türkiye)

Location

Related Publications (18)

• 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.

  PMID: 22494388 BACKGROUND

• 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.

  PMID: 28797618 BACKGROUND

• 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.

  PMID: 26482234 BACKGROUND

• 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.

  PMID: 20616328 BACKGROUND

• 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.

  PMID: 27118792 BACKGROUND

• 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.

  PMID: 23728680 BACKGROUND

• 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.

  PMID: 27821673 BACKGROUND

• 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.

  PMID: 16148357 BACKGROUND

• 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.

  PMID: 26451007 BACKGROUND

• 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.

  PMID: 26180337 BACKGROUND

• 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.

  PMID: 22503739 BACKGROUND

• 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.

  PMID: 27415645 BACKGROUND

• 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.

  PMID: 25250836 BACKGROUND

• 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.

  PMID: 30902629 BACKGROUND

• 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.

  PMID: 20298832 BACKGROUND

• 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.

  PMID: 23416218 BACKGROUND

• 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.

  PMID: 28392324 BACKGROUND

• 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.

  PMID: 22306324 BACKGROUND

Related Links

• World Health Organization Global Report on Falls Prevention in Older Age 2007
• The effects of comprehensive core body resistance exercise on lower extremity motor function among stroke survivors
• The Turkish version of the Activities Specific Balance Confidence (ABC) Scale: its cultural adaptation, validation and reliability in older adults

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aslıhan Kırktepeli

  Istanbul University- Cerrahpasa /Institute of Postgraduate Education

  PRINCIPAL INVESTIGATOR

• İpek Yeldan

  Istanbul University- Cerrahpasa / Faculty of Health Science

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 17, 2020
• Study Start: July 11, 2021
• Primary Completion: November 30, 2021
• Study Completion: March 16, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

TU (1)