search
Back to results

Core Stabilization Exercises in Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Core stabilization exercises
Multifactorial Education Program
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Falling, Fall, Core stabilization, Core exercising, Cerebrovascular Accident, Fall prevention

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bursa Ilker Celikcan Physical Therapy and Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Core Stabilization Group

Multifactorial Education Program Group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The Activities-Specific Balance Confidence (ABC) Scale
It will be used to assess balance confidence during a total of 16 activities performed inside and outside the home in daily life. Patients will score each activity from 0% (I'm not safe) to 100% (I'm completely safe). Maximum score is 100 point and approaching this value indicates that the balance confidence is good. A score below 63.75 indicates the risk of falling. At the end of treatment, the score is expected to be higher than the baseline and this value.
Fugl Meyer Assessment Lower Extremity (FMA-LE)
This test evaluate reflexes, motor recovery, voluntary movements, coordination and speed dependent on synergy or independent of synergy in the lower extremity. It consists of 17 items and the maximum score is 34. Higher scores indicate greater motor recovery. In order to have a minimal clinically significant change, there should be a 6-point change before and after treatment.
The Five Times Sit-to-Stand Test
The patient sits on the chair with feet on the floor and back straight and asked to get up and sit from the chair 5 times repeatedly at the speed patient can by crossing his arms on his chest, and the elapsed time is recorded in seconds. The shorter the time to complete the test indicates better lower extremity function. In order to have a minimal clinically significant change, there should be a 2.3 seconds change before and after treatment.
The Four Square Step Test (FSST)
Four squares are created by placing two walking sticks on the floor and the squares are numbered from 1 to 4. Patients stand on the number 1 square and step back to the right, back, left and forward in the order of the numbers, and then move on to the number 1 square again. The same stepping is performed in the opposite direction. The elapsed time is recorded. The shorter the time to complete the test indicates better lower extremity function and dynamic balance. Completing the test in more than 15 seconds shows the risk of falling. In order to have a minimal clinically significant change, there should be a 6.73 seconds change before and after treatment.
The Modified Kraus-Weber Test
Although it is a test that evaluates the strength and endurance of the trunk muscles, it consists of 2 main parts. There are 2 separate tests in the strength section and they are graded between 0-5 points. Endurance section consists of 5 tests in total and is graded between 0-6. Total score is 40. Higher scores indicate better trunk strength and endurance. The difference in points will be checked before and after treatment.
Berg Balance Scale
It is a valid and reliable test that evaluates balance both statically and dynamically. The 14 basic functions are evaluated by observation and scored between 0 and 4. Total score is 56. Higher scores indicate better balance function. Scoring below 45 indicates the risk of falling. In order to have a minimal clinically significant change, there should be a 4 point change before and after treatment.
The Single Leg Stance Test
Patients are asked to raise one leg while standing. The time is started when the patient lifts his foot. The time is stopped when the patient touches the ground. If he stands on one leg for 30 seconds, the test is finished. Being able to stand on one leg for less than 5 seconds indicates an increased risk of falling. In order to have a minimal clinically significant change, there should be a 6.7 seconds change before and after treatment.
Timed Up and Go Test
Patients are asked to stand up from the chair without arm support, walk 3 meters and return to the chair again. The elapsed time is recorded in seconds. The shorter the time to complete the test indicates better dynamic balance and mobility. Completing the test in more than 15 seconds shows the risk of falling. In order to have a minimal clinically significant change, there should be a 2.9 seconds change before and after treatment.

Full Information

First Posted
December 12, 2020
Last Updated
August 12, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
search

1. Study Identification

Unique Protocol Identification Number
NCT04673123
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 11, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Falling, Fall, Core stabilization, Core exercising, Cerebrovascular Accident, Fall prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Core Stabilization Group
Arm Type
Experimental
Arm Description
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)
Arm Title
Multifactorial Education Program Group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Core stabilization exercises
Intervention Description
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
Intervention Name(s)
Multifactorial Education Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of falls
Description
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.
Time Frame
The number of falls will be questioned following three months after the treatment program completed.
Secondary Outcome Measure Information:
Title
The Activities-Specific Balance Confidence (ABC) Scale
Description
It will be used to assess balance confidence during a total of 16 activities performed inside and outside the home in daily life. Patients will score each activity from 0% (I'm not safe) to 100% (I'm completely safe). Maximum score is 100 point and approaching this value indicates that the balance confidence is good. A score below 63.75 indicates the risk of falling. At the end of treatment, the score is expected to be higher than the baseline and this value.
Time Frame
It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
Title
Fugl Meyer Assessment Lower Extremity (FMA-LE)
Description
This test evaluate reflexes, motor recovery, voluntary movements, coordination and speed dependent on synergy or independent of synergy in the lower extremity. It consists of 17 items and the maximum score is 34. Higher scores indicate greater motor recovery. In order to have a minimal clinically significant change, there should be a 6-point change before and after treatment.
Time Frame
It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
Title
The Five Times Sit-to-Stand Test
Description
The patient sits on the chair with feet on the floor and back straight and asked to get up and sit from the chair 5 times repeatedly at the speed patient can by crossing his arms on his chest, and the elapsed time is recorded in seconds. The shorter the time to complete the test indicates better lower extremity function. In order to have a minimal clinically significant change, there should be a 2.3 seconds change before and after treatment.
Time Frame
It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
Title
The Four Square Step Test (FSST)
Description
Four squares are created by placing two walking sticks on the floor and the squares are numbered from 1 to 4. Patients stand on the number 1 square and step back to the right, back, left and forward in the order of the numbers, and then move on to the number 1 square again. The same stepping is performed in the opposite direction. The elapsed time is recorded. The shorter the time to complete the test indicates better lower extremity function and dynamic balance. Completing the test in more than 15 seconds shows the risk of falling. In order to have a minimal clinically significant change, there should be a 6.73 seconds change before and after treatment.
Time Frame
It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
Title
The Modified Kraus-Weber Test
Description
Although it is a test that evaluates the strength and endurance of the trunk muscles, it consists of 2 main parts. There are 2 separate tests in the strength section and they are graded between 0-5 points. Endurance section consists of 5 tests in total and is graded between 0-6. Total score is 40. Higher scores indicate better trunk strength and endurance. The difference in points will be checked before and after treatment.
Time Frame
It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
Title
Berg Balance Scale
Description
It is a valid and reliable test that evaluates balance both statically and dynamically. The 14 basic functions are evaluated by observation and scored between 0 and 4. Total score is 56. Higher scores indicate better balance function. Scoring below 45 indicates the risk of falling. In order to have a minimal clinically significant change, there should be a 4 point change before and after treatment.
Time Frame
It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment.
Title
The Single Leg Stance Test
Description
Patients are asked to raise one leg while standing. The time is started when the patient lifts his foot. The time is stopped when the patient touches the ground. If he stands on one leg for 30 seconds, the test is finished. Being able to stand on one leg for less than 5 seconds indicates an increased risk of falling. In order to have a minimal clinically significant change, there should be a 6.7 seconds change before and after treatment.
Time Frame
It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
Title
Timed Up and Go Test
Description
Patients are asked to stand up from the chair without arm support, walk 3 meters and return to the chair again. The elapsed time is recorded in seconds. The shorter the time to complete the test indicates better dynamic balance and mobility. Completing the test in more than 15 seconds shows the risk of falling. In order to have a minimal clinically significant change, there should be a 2.9 seconds change before and after treatment.
Time Frame
It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aslıhan Kırktepeli
Organizational Affiliation
Istanbul University- Cerrahpasa /Institute of Postgraduate Education
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İpek Yeldan
Organizational Affiliation
Istanbul University- Cerrahpasa / Faculty of Health Science
Official's Role
Study Chair
Facility Information:
Facility Name
Bursa Ilker Celikcan Physical Therapy and Rehabilitation Hospital
City
Bursa
State/Province
Osmangazi
ZIP/Postal Code
16170
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
22494388
Citation
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.
Results Reference
background
PubMed Identifier
28797618
Citation
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.
Results Reference
background
PubMed Identifier
26482234
Citation
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.
Results Reference
background
PubMed Identifier
20616328
Citation
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.
Results Reference
background
PubMed Identifier
27118792
Citation
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.
Results Reference
background
PubMed Identifier
23728680
Citation
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.
Results Reference
background
PubMed Identifier
27821673
Citation
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.
Results Reference
background
PubMed Identifier
16148357
Citation
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.
Results Reference
background
PubMed Identifier
26451007
Citation
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.
Results Reference
background
PubMed Identifier
26180337
Citation
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.
Results Reference
background
PubMed Identifier
22503739
Citation
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.
Results Reference
background
PubMed Identifier
27415645
Citation
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.
Results Reference
background
PubMed Identifier
25250836
Citation
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.
Results Reference
background
PubMed Identifier
30902629
Citation
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.
Results Reference
background
PubMed Identifier
20298832
Citation
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.
Results Reference
background
PubMed Identifier
23416218
Citation
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.
Results Reference
background
PubMed Identifier
28392324
Citation
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.
Results Reference
background
PubMed Identifier
22306324
Citation
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.
Results Reference
background
Links:
URL
http://extranet.who.int/agefriendlyworld/wp-content/uploads/2014/06/WHo-Global-report-on-falls-prevention-in-older-age.pdf
Description
World Health Organization Global Report on Falls Prevention in Older Age 2007
URL
https://iopscience.iop.org/article/10.1088/1742-6596/1358/1/012025/pdf
Description
The effects of comprehensive core body resistance exercise on lower extremity motor function among stroke survivors
URL
http://geriatri.dergisi.org/abstract.php?id=811
Description
The Turkish version of the Activities Specific Balance Confidence (ABC) Scale: its cultural adaptation, validation and reliability in older adults
URL
https://www.mdpi.com/2072-6643/11/4/868/htm
Description
Aerobic Exercise Training with Brisk Walking Increases Intestinal Bacteroides in Healthy Elderly Women

Learn more about this trial

Core Stabilization Exercises in Stroke

We'll reach out to this number within 24 hrs