StrokeNCT04673123

Core Stabilization Exercises in Stroke

A study testing Core stabilization exercises and Multifactorial Education Program in people with Stroke, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 45 to 75 years
Conditions the study is for: Stroke
What is being tested?: Core stabilization exercises and Multifactorial Education Program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 11 Jul 2021to 16 Mar 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Bursa Ilker Celikcan Physical Therapy and Rehabilitation Hospital
Bursa, Osmangazi, 16170

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Core Stabilization Exercises on Fall, Lower Limb Function, and Balance in Stroke Patients

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.

Read the 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.

Conditions: Stroke
Being tested: Core stabilization exercises, Multifactorial Education Program
Keywords: Stroke, Falling, Fall, Core stabilization, Core exercising, Cerebrovascular Accident, Fall prevention
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Core stabilization exercisesOther
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 ProgramOther
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

Study groups in NCT04673123
Study group	Role	What they receive
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) Receives: 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) Receives: Other: Multifactorial Education Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 202116 Mar 2022

First posted17 Dec 2020
Study start11 Jul 2021
Primary completion30 Nov 2021
Study completion16 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04673123
Sponsor's protocol ID: 2021-10/40
Status last verified: Aug 2022
First submitted: 12 Dec 2020
Last updated: 16 Aug 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 22494388
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.
PubMed 28797618
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.
PubMed 26482234
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.
PubMed 20616328
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.
PubMed 27118792
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.
PubMed 23728680
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.
PubMed 27821673
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.
PubMed 16148357
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.
PubMed 26451007
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.
PubMed 26180337
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.
PubMed 22503739
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.
PubMed 27415645
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.
PubMed 25250836
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.
PubMed 30902629
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.
PubMed 20298832

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Core Stabilization Exercises on Fall, Lower Limb Function, and Balance in Stroke Patients
ClinicalTrials.gov ID: NCT04673123
Acronym / sponsor ID: 2021-10/40
Conditions: Stroke
Keywords: Stroke, Falling, Fall, Core stabilization, Core exercising, Cerebrovascular Accident, Fall prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Istanbul University - CerrahpasaUniversity, hospital or other
Study start: 11 Jul 2021 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 16 Mar 2022 (actual)
First posted: 17 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Core Stabilization Group	Experimental	Other: Core stabilization exercises, Other: Multifactorial Education ProgramCore 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 Group	Active comparator	Other: Multifactorial Education ProgramMultifactorial 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)

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Core stabilization exercisesIn 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.	Other	Core Stabilization Group
Multifactorial Education ProgramThe 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	Other	Core Stabilization Group, Multifactorial Education Program Group

Primary outcome

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

8 secondary outcomes

The Activities-Specific Balance Confidence (ABC) Scale
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
Berg Balance Scale
Time frame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment.
The Single Leg Stance Test
Time frame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.
Timed Up and Go Test
Time frame: It will be evaluated at the beginning of treatment and 12 weeks after the initiation of treatment for each patient.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
Background: PubMed 22494388Batchelor 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.
Background: PubMed 28797618Xu 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.
Background: PubMed 26482234Schinkel-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.
Background: PubMed 20616328Batchelor 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.
Background: PubMed 27118792Quigley 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.
Background: PubMed 23728680Verheyden 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.
Background: PubMed 27821673Haruyama 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.
Background: PubMed 16148357Willson 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.
Background: PubMed 26451007Cabanas-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.
Background: PubMed 26180337Jung 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.
Background: PubMed 22503739Batchelor 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.
Background: PubMed 27415645Vahlberg 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.
World Health Organization Global Report on Falls Prevention in Older Age 2007Link provided by the sponsor.
The effects of comprehensive core body resistance exercise on lower extremity motor function among stroke survivorsLink provided by the sponsor.
The Turkish version of the Activities Specific Balance Confidence (ABC) Scale: its cultural adaptation, validation and reliability in older adultsLink provided by the sponsor.

Related trials for Stroke

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aslıhan Kırktepeli principal investigator

Istanbul University- Cerrahpasa /Institute of Postgraduate Education

İpek Yeldan study chair

Istanbul University- Cerrahpasa / Faculty of Health Science

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Core stabilization exercises and Multifactorial Education Program in people with Stroke, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of falls (time frame: The number of falls will be questioned following three months after the treatment program completed.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673123, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.