Lumbar Spinal Manipulation in Stroke

NCT07619586 | Not Yet Recruiting

• 1 other identifier: BEUFTR-12
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Balance

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Anteroposterior Stability Index Measurement

  Change from baseline anteroposterior postural stability index immediately after the intervention

• Mediolateral Stability Index Measurement

  Change from baseline mediolateral stability index immediately after the intervention

Study Arms (2)

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.

Other: Lumbar Spinal Manipulation; Other: Placebo Lumbar Spinal Manipulation

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.

Other: Lumbar Spinal Manipulation; Other: Placebo Lumbar Spinal Manipulation

Interventions

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.

Active Comparator: Lumbar Spinal Manipulation Group; Placebo Comparator: Placebo Lumbar Spinal Manipulation Group

Placebo Lumbar Spinal Manipulation OTHER

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

Active Comparator: Lumbar Spinal Manipulation Group; Placebo Comparator: Placebo Lumbar Spinal Manipulation Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bolu, Bolu, Merkez, 14280, Turkey (Türkiye)

Location

Related Publications (17)

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• 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.

  PMID: 10584668 BACKGROUND

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  PMID: 19903653 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.

  PMID: 12574566 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.

  PMID: 16386060 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.

  PMID: 12173758 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.

  PMID: 19628798 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.

  PMID: 29740561 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.

  PMID: 25133141 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.

  PMID: 24756870 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.

  PMID: 16214666 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.

  PMID: 39940031 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.

  PMID: 35759843 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.

  PMID: 40911798 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.

  PMID: 40312450 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.

  PMID: 30121128 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Ömer Dursun, Assoc. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• Merve Tunçdemir, Asst. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• Burak Mavuş, M.Sc.

  Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Dursun, Assoc. Prof.

CONTACT

05426088687; fztomrdrsn@gmail.com

Burak Mavuş, M.Sc.

CONTACT

5388178351; a.burakmavus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

TU (1)