Lumbar Spinal Manipulation in Stroke
13 juni 2026 bijgewerkt door: Omer Dursun, Bitlis Eren University
Effects of Lumbar Spinal Manipulation on Balance and Fall Risk in Patients With Chronic Stroke: A Randomized Crossover Trial
The aim of the study is to investigate the effects of lumbar spinal manipulation on balance and fall risk of the patients with chronic stroke.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The study, utilizing a randomized crossover design, is planned to be conducted on a minimum of 26 patients with stroke who meet the inclusion and exclusion criteria.
Patients included in the study will be randomly assigned to receive both placebo lumbar spinal manipulation and lumbar spinal manipulation interventions.
Studietype
Ingrijpend
Inschrijving (Geschat)
52
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: burak mavuş, M.Sc.
- Telefoonnummer: +90 5388178351
- E-mail: a.burakmavus@gmail.com
Studie Contact Back-up
- Naam: Ömer Dursun, Assoc. Prof.
- Telefoonnummer: 05426088687
- E-mail: fztomrdrsn@gmail.com
Studie Locaties
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Bolu, Merkez
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Bolu, Bolu, Merkez, Turkije (Türkiye), 14280
- Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
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Contact:
- Birkan Özkardaş, Mr.
- Telefoonnummer: +90 5550639585
- E-mail: brknzkrds31@gmail.com
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Contact:
- burak mavuş, M.Sc.
- Telefoonnummer: +90 5388178351
- E-mail: a.burakmavus@gmail.com
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Having chronic stroke,
- A Mini-Mental State Examination score of 24 or higher,
- Ability to stand independently for 20 seconds or more,
- Being between 18 and 75 years of age,
- Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary,
- Daily blood pressure not exceeding 140/90 mmHg (or controlled with antihypertensive medication)
Exclusion Criteria:
- Presence of severe cardiac, pulmonary, hepatic, or renal dysfunction,
- Presence of severe bone or joint disease, particularly affecting the spine,
- Presence of risk factors for osteoporosis, especially involving the spine,
- Orthopedic conditions limiting spinal rotation,
- History of cancer or diabetic neuropathy,
- Presence of vestibular disorders,
- Presence of lower extremity ulceration or amputation,
- Alcohol consumption within the last 24 hours,
- Hemodynamic instability,
- Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum,
- Presence of neurological diseases such as multiple sclerosis or Parkinson's disease,
- History of acute lower extremity injury within the last 6 weeks,
- History of lower extremity surgery
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: Placebo Comparator: Placebo Lumbar Spinal Manipulation Group
Participants will receive placebo lumbar spinal manipulation in the first session and lumbar spinal manipulation after a washout period.
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This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility.
This intervention is a classic method used to evaluate the effect of lumbar spinal manipulation.
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Actieve vergelijker: Active Comparator: Lumbar Spinal Manipulation Group
Participants will receive lumbar spinal manipulation in the first session and placebo lumbar spinal manipulation after a washout period.
|
This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility.
This intervention is a classic method used to evaluate the effect of lumbar spinal manipulation.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Overall Postural Stability Index Measurement
Tijdsspanne: Change from baseline overall postural stability index immediately after the intervention
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This index will be assessed by measuring deviations of the center of gravity in the anteroposterior and mediolateral directions.
Lower scores indicate smaller deviations and better postural stability.
The test will be performed on a stable platform with three trials of 30 seconds each.
The average of the three trials will be automatically calculated by the TechnoBody balance system.
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Change from baseline overall postural stability index immediately after the intervention
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Fall Risk Assessment
Tijdsspanne: Change from baseline fall risk immediately after the intervention
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Fall risk will be assessed by measuring the patient's ability to maintain balance on an unstable platform.
Based on their ability to maintain balance, a fall risk score will be generated, with higher scores indicating a greater risk of falling.
The test will be performed with three 30-second trials.
The average of the three trials will be calculated automatically by the TechnoBody balance system.
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Change from baseline fall risk immediately after the intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Anteroposterior Stability Index Measurement
Tijdsspanne: Change from baseline anteroposterior postural stability index immediately after the intervention
|
The anteroposterior stability index will be assessed by measuring deviations of the center of gravity in the anteroposterior direction.
Lower scores indicate smaller deviations and better anteroposterior postural stability.
The test will be performed on a stable platform with three trials of 30 seconds each.
The average of the three trials will be automatically calculated by the TechnoBody balance system.
|
Change from baseline anteroposterior postural stability index immediately after the intervention
|
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Mediolateral Stability Index Measurement
Tijdsspanne: Change from baseline mediolateral stability index immediately after the intervention
|
The mediolateral stability index will be assessed by measuring deviations of the center of gravity in the mediolateral direction.
Lower scores indicate smaller deviations and better mediolateral postural stability.
The test will be performed on a stable platform with three trials of 30 seconds each.
The average of the three trials will be automatically calculated by the TechnoBody balance system.
|
Change from baseline mediolateral stability index immediately after the intervention
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: burak mavuş, M.Sc., Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
- Hoofdonderzoeker: merve tunçdemir, Asst. Prof., Bitlis Eren University
- Hoofdonderzoeker: Ömer DURSUN, Assoc. Prof., Bitlis Eren University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Geurts AC, de Haart M, van Nes IJ, Duysens J. A review of standing balance recovery from stroke. Gait Posture. 2005 Nov;22(3):267-81. doi: 10.1016/j.gaitpost.2004.10.002. Epub 2004 Dec 7.
- Arene N, Hidler J. Understanding motor impairment in the paretic lower limb after a stroke: a review of the literature. Top Stroke Rehabil. 2009 Sep-Oct;16(5):346-56. doi: 10.1310/tsr1605-346.
- Speelman AD, van de Warrenburg BP, van Nimwegen M, Petzinger GM, Munneke M, Bloem BR. How might physical activity benefit patients with Parkinson disease? Nat Rev Neurol. 2011 Jul 12;7(9):528-34. doi: 10.1038/nrneurol.2011.107.
- Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.
- Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
- Yates JS, Lai SM, Duncan PW, Studenski S. Falls in community-dwelling stroke survivors: an accumulated impairments model. J Rehabil Res Dev. 2002 May-Jun;39(3):385-94.
- Divani AA, Vazquez G, Barrett AM, Asadollahi M, Luft AR. Risk factors associated with injury attributable to falling among elderly population with history of stroke. Stroke. 2009 Oct;40(10):3286-92. doi: 10.1161/STROKEAHA.109.559195. Epub 2009 Jul 23.
- Lamb SE, Ferrucci L, Volapto S, Fried LP, Guralnik JM; Women's Health and Aging Study. Risk factors for falling in home-dwelling older women with stroke: the Women's Health and Aging Study. Stroke. 2003 Feb;34(2):494-501.
- del Pozo-Cruz B, Adsuar JC, Parraca JA, del Pozo-Cruz J, Olivares PR, Gusi N. Using whole-body vibration training in patients affected with common neurological diseases: a systematic literature review. J Altern Complement Med. 2012 Jan;18(1):29-41. doi: 10.1089/acm.2010.0691. Epub 2012 Jan 10.
- Wenning GK, Ebersbach G, Verny M, Chaudhuri KR, Jellinger K, McKee A, Poewe W, Litvan I. Progression of falls in postmortem-confirmed parkinsonian disorders. Mov Disord. 1999 Nov;14(6):947-50. doi: 10.1002/1531-8257(199911)14:63.0.co;2-o.
- Chen JC, Shaw FZ. Progress in sensorimotor rehabilitative physical therapy programs for stroke patients. World J Clin Cases. 2014 Aug 16;2(8):316-26. doi: 10.12998/wjcc.v2.i8.316.
- Tyson SF, Hanley M, Chillala J, Selley A, Tallis RC. Balance disability after stroke. Phys Ther. 2006 Jan;86(1):30-8. doi: 10.1093/ptj/86.1.30.
- Joo S, Lee Y, Song CH. Immediate Effects of Thoracic Spinal Manipulation on Pulmonary Function in Stroke Patients: A Preliminary Study. J Manipulative Physiol Ther. 2018 Sep;41(7):602-608. doi: 10.1016/j.jmpt.2017.12.005. Epub 2018 Aug 16.
- Chen C, Yan B, He S, Wu R, Han X, Chen Y, Chen H, Xie L. Effects of lumbar joint mobilization on trunk control, balance, and gait in patients with stroke: study protocol for a randomized controlled trial. Trials. 2025 Feb 12;26(1):50. doi: 10.1186/s13063-025-08767-0.
- Park SJ, Cho KH. The Immediate Effects of Lumbar Rotational Mobilization on Trunk Control and Gait Parameter in Patients with Stroke. J Stroke Cerebrovasc Dis. 2022 Aug;31(8):106582. doi: 10.1016/j.jstrokecerebrovasdis.2022.106582. Epub 2022 Jun 24.
- Dursun O, Mavus AB. The effect of talocrural joint manipulation on static balance in patients with stroke: a randomized crossover trial. Physiother Theory Pract. 2025 Nov;41(11):2352-2364. doi: 10.1080/09593985.2025.2556133. Epub 2025 Sep 5.
- Diao Y, Liu Y, Pan J, Chen J, Pan J, Liao M, Liu H, Liao L. Efficacy and safety of spinal manipulative therapy in the management of acute neck pain: a systematic review and meta-analysis. Syst Rev. 2025 May 1;14(1):97. doi: 10.1186/s13643-025-02855-7.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
15 augustus 2026
Primaire voltooiing (Geschat)
15 december 2026
Studie voltooiing (Geschat)
15 december 2026
Studieregistratiedata
Eerst ingediend
26 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
26 mei 2026
Eerst geplaatst (Werkelijk)
2 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
13 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BEUFTR-12
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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