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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.
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 thoracic spinal manipulation and thoracic spinal manipulation interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 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 |
| 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 two 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 | Affiliation | Role |
|---|---|---|
| ömer dursun, Assoc. Prof. | Bitlis Eren University | Principal Investigator |
| burak mavuÅŸ, M.Sc. | Bolu Abant Ä°zzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital | Principal Investigator |
| merve tunçdemir, Asst. Prof. | Bitlis Eren University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi | Bolu | Merkez | 14280 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12625651 | Background | 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. | |
| 25624827 | 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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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.
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The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.
| Placebo Thoracic Spinal Manipulation | Other | This intervention is a classic method used to evaluate the effect of thoracic spinal manipulation. |
|
| Change from baseline overall 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 two 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 |
| Thoracic Mobility | Thoracic mobility will be assessed by measuring trunk rotation and lateral flexion using a smartphone inclinometer positioned at the level of T2. | Change from baseline mediolateral stability index immediately after the intervention |
| 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. |
| 12440800 | 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. |
| 12411652 | 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. |
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| 16096256 | 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. |
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| 19608100 | 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. |
| 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. |
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| 15922233 | 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. |
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| 27799691 | 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. |
| 19027342 | 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. |
| 12372310 | 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. |
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| 19243723 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |