Lumbar Spinal Manipulation in Stroke
2026年6月13日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
52
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：burak mavuş, M.Sc.
- 电话号码：+90 5388178351
- 邮箱：a.burakmavus@gmail.com
研究联系人备份
- 姓名：Ömer Dursun, Assoc. Prof.
- 电话号码：05426088687
- 邮箱：fztomrdrsn@gmail.com
学习地点
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Bolu, Merkez
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Bolu、Bolu, Merkez、土耳其（türkiye）、14280
- Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
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接触：
- Birkan Özkardaş, Mr.
- 电话号码：+90 5550639585
- 邮箱：brknzkrds31@gmail.com
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接触：
- burak mavuş, M.Sc.
- 电话号码：+90 5388178351
- 邮箱：a.burakmavus@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：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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有源比较器：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Postural Stability Index Measurement
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anteroposterior Stability Index Measurement
大体时间：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
|
|
Mediolateral Stability Index Measurement
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：burak mavuş, M.Sc.、Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
- 首席研究员：merve tunçdemir, Asst. Prof.、Bitlis Eren University
- 首席研究员：Ömer DURSUN, Assoc. Prof.、Bitlis Eren University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月15日
初级完成 (估计的)
2026年12月15日
研究完成 (估计的)
2026年12月15日
研究注册日期
首次提交
2026年5月26日
首先提交符合 QC 标准的
2026年5月26日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月13日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.