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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: Placebo Lumbar Spinal Manipulation Group | Placebo Comparator | Participants will receive placebo lumbar spinal manipulation in the first session and lumbar spinal manipulation after a washout period. |
|
| Active Comparator: Lumbar Spinal Manipulation Group | Active Comparator | Participants will receive lumbar spinal manipulation in the first session and placebo lumbar spinal manipulation after a washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Spinal Manipulation | Other | This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Postural Stability Index Measurement | 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. | Change from baseline overall postural stability index immediately after the intervention |
| Fall Risk Assessment | 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. | Change from baseline fall risk immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Anteroposterior Stability Index Measurement | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ömer Dursun, Assoc. Prof. | Contact | 05426088687 | fztomrdrsn@gmail.com | |
| Burak Mavuş, M.Sc. | Contact | 5388178351 | +90 | a.burakmavus@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ömer Dursun, Assoc. Prof. | Bitlis Eren University | Principal Investigator |
| Merve Tunçdemir, Asst. Prof. | Bitlis Eren University | Principal Investigator |
| Burak Mavuş, M.Sc. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi | Bolu | Bolu, Merkez | 14280 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22233167 | Background | 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. | |
| 21750523 | Background |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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The patients enrolled in the study will receive placebo lumbar spinal manipulation and lumbar spinal manipulation in a randomized sequence. The order of the interventions will be determined by flipping a coin.
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The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.
| Placebo Lumbar Spinal Manipulation | Other | This intervention is a classic method used to evaluate the effect of lumbar spinal manipulation. |
|
| Change from baseline anteroposterior postural stability index immediately after the intervention |
| Mediolateral Stability Index Measurement | 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 |
| Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital |
| Principal Investigator |
| 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. |
| 10584668 | Background | 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. |
| 19903653 | Background | 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. |
| 12574566 | Background | 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. |
| 16386060 | Background | 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. |
| 12173758 | Background | 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. |
| 19628798 | Background | 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. |
| 29740561 | Background | 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. |
| 25133141 | Background | 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. |
| 24756870 | Background | 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. |
| 16214666 | Background | 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. |
| 39940031 | Background | 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. |
| 35759843 | Background | 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. |
| 40911798 | Background | 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. |
| 40312450 | Background | 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. |
| 30121128 | Background | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |