Thoracic Spinal Manipulation in Stroke

NCT07436975 | Recruiting

• 1 other identifier: BEUFTR-11
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the effects of thoracic spinal manipulation on balance, fall risk, and thoracic mobility 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 two 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 two 30-second trials. The average of the three trials will be calculated automatically by the TechnoBody balance system.

  Change from baseline overall postural stability index immediately after the intervention

Secondary Outcomes (3)

• Anteroposterior Stability Index Measurement

  Change from baseline overall postural stability index immediately after the intervention

• Mediolateral Stability Index Measurement

  Change from baseline mediolateral stability index immediately after the intervention

• Thoracic Mobility

  Change from baseline mediolateral stability index immediately after the intervention

Study Arms (2)

PlaceboThoracic Spinal Manipulation Group

PLACEBO COMPARATOR

Participants will receive placebo thoracic manipulation in the first session and thoracic spinal manipulation after a one-week washout period.

Other: Thoracic Spinal Manipulation; Other: Placebo Thoracic Spinal Manipulation

Thoracic Spinal Manipulation Group

ACTIVE COMPARATOR

Participants will receive thoracic spinal manipulation in the first session and placebo thoracic manipulation after a one-week washout period.

Other: Thoracic Spinal Manipulation; Other: Placebo Thoracic Spinal Manipulation

Interventions

Thoracic Spinal Manipulation OTHER

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

PlaceboThoracic Spinal Manipulation Group; Thoracic Spinal Manipulation Group

Placebo Thoracic Spinal Manipulation OTHER

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

PlaceboThoracic Spinal Manipulation Group; Thoracic Spinal Manipulation Group

Eligibility Criteria

• Age: 40 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,
• Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary,
• Being between 40 and 75 years of age,
• Having a Brunnstrom stage of 4 or above

You may not qualify if:

• History of whiplash injury,
• Diagnosis of fibromyalgia,
• History of spinal manipulation treatment within the previous 2 months,
• History of cervical or thoracic fracture or dislocation,
• History of cervical or thoracic spine surgery,
• Diagnosis of cervical radiculopathy or myelopathy,
• Presence of serious spinal pathology,
• Presence of any orthopedic or neurological disorder other than stroke, or an unstable cardiac condition,
• Presence of a vestibular disorder,
• The presence of lower extremity ulceration or amputation,
• Alcohol consumption in the last 24 hours,
• Posterior circulation stroke involving the basilar artery or cerebellum,
• Having experienced an acute lower extremity injury in the last six 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, Merkez, 14280, Turkey (Türkiye)

RECRUITING

Related Publications (22)

• Meijer R, Ihnenfeldt DS, de Groot IJ, van Limbeek J, Vermeulen M, de Haan RJ. Prognostic factors for ambulation and activities of daily living in the subacute phase after stroke. A systematic review of the literature. Clin Rehabil. 2003 Mar;17(2):119-29. doi: 10.1191/0269215503cr585oa.

  PMID: 12625651 BACKGROUND

• Karthikbabu S, Chakrapani M, Ganeshan S, Rakshith KC, Nafeez S, Prem V. A review on assessment and treatment of the trunk in stroke: A need or luxury. Neural Regen Res. 2012 Sep 5;7(25):1974-7. doi: 10.3969/j.issn.1673-5374.2012.25.008.

  PMID: 25624827 BACKGROUND

• Duarte E, Marco E, Muniesa JM, Belmonte R, Diaz P, Tejero M, Escalada F. Trunk control test as a functional predictor in stroke patients. J Rehabil Med. 2002 Nov;34(6):267-72. doi: 10.1080/165019702760390356.

  PMID: 12440800 BACKGROUND

• Hsieh CL, Sheu CF, Hsueh IP, Wang CH. Trunk control as an early predictor of comprehensive activities of daily living function in stroke patients. Stroke. 2002 Nov;33(11):2626-30. doi: 10.1161/01.str.0000033930.05931.93.

  PMID: 12411652 BACKGROUND

• Verheyden G, Nieuwboer A, De Wit L, Feys H, Schuback B, Baert I, Jenni W, Schupp W, Thijs V, De Weerdt W. Trunk performance after stroke: an eye catching predictor of functional outcome. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):694-8. doi: 10.1136/jnnp.2006.101642. Epub 2006 Dec 18.

  PMID: 17178824 BACKGROUND

• Verheyden G, Nieuwboer A, Feys H, Thijs V, Vaes K, De Weerdt W. Discriminant ability of the Trunk Impairment Scale: A comparison between stroke patients and healthy individuals. Disabil Rehabil. 2005 Sep 2;27(17):1023-8. doi: 10.1080/09638280500052872.

  PMID: 16096256 BACKGROUND

• Jeong YJ, Kim GS, Jeong YG, Moon HI. Can Pulmonary Function Testing Predict the Functional Outcomes of Poststroke Patients?: An Observational Study. Am J Phys Med Rehabil. 2020 Dec;99(12):1145-1149. doi: 10.1097/PHM.0000000000001507.

  PMID: 32576744 BACKGROUND

• Sunderland A, Tinson D, Bradley L, Hewer RL. Arm function after stroke. An evaluation of grip strength as a measure of recovery and a prognostic indicator. J Neurol Neurosurg Psychiatry. 1989 Nov;52(11):1267-72. doi: 10.1136/jnnp.52.11.1267.

  PMID: 2592969 BACKGROUND

• Ryerson S, Byl NN, Brown DA, Wong RA, Hidler JM. Altered trunk position sense and its relation to balance functions in people post-stroke. J Neurol Phys Ther. 2008 Mar;32(1):14-20. doi: 10.1097/NPT.0b013e3181660f0c.

  PMID: 18463551 BACKGROUND

• Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.

  PMID: 19608100 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

• Paris SV. Spinal manipulative therapy. Clin Orthop Relat Res. 1983 Oct;(179):55-61.

  PMID: 6225596 BACKGROUND

• Cleland JA, Childs JD, McRae M, Palmer JA, Stowell T. Immediate effects of thoracic manipulation in patients with neck pain: a randomized clinical trial. Man Ther. 2005 May;10(2):127-35. doi: 10.1016/j.math.2004.08.005.

  PMID: 15922233 BACKGROUND

• Lee M, Latimer J, Maher C. Manipulation: investigation of a proposed mechanism. Clin Biomech (Bristol). 1993 Nov;8(6):302-6. doi: 10.1016/0268-0033(93)90004-2.

  PMID: 23916050 BACKGROUND

• Shin DC, Lee YW. The immediate effects of spinal thoracic manipulation on respiratory functions. J Phys Ther Sci. 2016 Sep;28(9):2547-2549. doi: 10.1589/jpts.28.2547. Epub 2016 Sep 29.

  PMID: 27799691 BACKGROUND

• Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.

  PMID: 19027342 BACKGROUND

• Gross AR, Kay T, Hondras M, Goldsmith C, Haines T, Peloso P, Kennedy C, Hoving J. Manual therapy for mechanical neck disorders: a systematic review. Man Ther. 2002 Aug;7(3):131-49. doi: 10.1054/math.2002.0465.

  PMID: 12372310 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Good DC, Bettermann K, Reichwein RK. Stroke rehabilitation. Continuum (Minneap Minn). 2011 Jun;17(3 Neurorehabilitation):545-67. doi: 10.1212/01.CON.0000399072.61943.38.

  PMID: 22810867 BACKGROUND

• Arifin N, Abu Osman NA, Wan Abas WA. Intrarater test-retest reliability of static and dynamic stability indexes measurement using the Biodex Stability System during unilateral stance. J Appl Biomech. 2014 Apr;30(2):300-4. doi: 10.1123/jab.2013-0130. Epub 2013 Jul 20.

  PMID: 23878204 BACKGROUND

• Sohn MK, Jee SJ, Hwang P, Jeon Y, Lee H. The Effects of Shoulder Slings on Balance in Patients With Hemiplegic Stroke. Ann Rehabil Med. 2015 Dec;39(6):986-94. doi: 10.5535/arm.2015.39.6.986. Epub 2015 Dec 29.

  PMID: 26798614 BACKGROUND

• Learman KE, Myers JB, Lephart SM, Sell TC, Kerns GJ, Cook CE. Effects of spinal manipulation on trunk proprioception in subjects with chronic low back pain during symptom remission. J Manipulative Physiol Ther. 2009 Feb;32(2):118-26. doi: 10.1016/j.jmpt.2008.12.004.

  PMID: 19243723 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• ömer dursun, Asst. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• burak mavuş, M.Sc.

  Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• merve tunçdemir, Asst. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ömer dursun, Asst. Prof.

CONTACT

5426088687; 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: Asst. Prof.

Model Details: The patients enrolled in the study will receive placebo thoracic spinal manipulation and thoracic spinal manipulation in a randomized sequence. The order of the interventions will be determined by flipping a coin.

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: March 16, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

TU (1)