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Not yet recruitingNCT07619586Updated Jun 16, 2026

Lumbar Spinal Manipulation in Stroke

An interventional study of Lumbar Spinal Manipulation and Placebo Lumbar Spinal Manipulation in Stroke, sponsored by Bitlis Eren University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Bitlis Eren University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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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Conditions studied

  • Stroke

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Keywords

  • Balance
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 52 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Bitlis Eren University is the lead sponsor of 48 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Placebo comparator
    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.

    Other: Lumbar Spinal Manipulation · Other: Placebo Lumbar Spinal Manipulation

  • Active comparator
    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.

    Other: Lumbar Spinal Manipulation · Other: Placebo Lumbar Spinal Manipulation

Interventions

  • OtherLumbar Spinal Manipulation

    This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility.

  • OtherPlacebo Lumbar Spinal Manipulation

    This intervention is a classic method used to evaluate the effect of lumbar spinal manipulation.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline overall postural stability index immediately after the intervention

  2. 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.

    Time frame: Change from baseline fall risk immediately after the intervention

Secondary outcomes

  1. 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.

    Time frame: Change from baseline anteroposterior postural stability index immediately after the intervention

  2. 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.

    Time frame: Change from baseline mediolateral stability index immediately after the intervention

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Study locations

1 site
  • Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
    Bolu, Bolu, Merkez 14280, Turkey (Türkiye)
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References and documents

Publications

  • 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. PubMed 22233167 ↗
  • 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. PubMed 21750523 ↗
  • 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. PubMed 10584668 ↗
  • 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. PubMed 19903653 ↗
  • 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. PubMed 12574566 ↗
  • 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. PubMed 16386060 ↗
  • 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. PubMed 12173758 ↗
  • 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. PubMed 19628798 ↗
  • 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. PubMed 29740561 ↗
  • 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. PubMed 25133141 ↗
  • 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. PubMed 24756870 ↗
  • 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. PubMed 16214666 ↗
  • 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. PubMed 39940031 ↗
  • 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. PubMed 35759843 ↗
  • 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. PubMed 40911798 ↗
  • 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. PubMed 40312450 ↗
  • 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. PubMed 30121128 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07619586
Lead sponsor
Bitlis Eren University
Responsible party
Omer Dursun (Assoc. Prof., Bitlis Eren University) — Principal investigator
First posted
Jun 2, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Jun 16, 2026

Study contacts

Ömer Dursun, Assoc. Prof.
Contact
fztomrdrsn@gmail.com
05426088687
Burak Mavuş, M.Sc.
Contact
a.burakmavus@gmail.com
5388178351 ext. +90
Ömer Dursun, Assoc. Prof.
principal investigator · Bitlis Eren University
Merve Tunçdemir, Asst. Prof.
principal investigator · Bitlis Eren University
Burak Mavuş, M.Sc.
principal investigator · Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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