StrokeNCT07436975
Thoracic Spinal Manipulation in Stroke
A study testing Thoracic Spinal Manipulation in people with Stroke, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Thoracic Spinal Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2026to 22 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Bolu, Merkez, 14280
About this study
Official title: Effects of Thoracic Spinal Manipulation on Balance, Fall Risk, and Thoracic Mobility in Patients With Chronic Stroke: A Randomized Crossover Trial
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.
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 thoracic spinal manipulation and thoracic spinal manipulation interventions.
- Conditions
- Stroke
- Being tested
- Thoracic Spinal Manipulation, Placebo Thoracic Spinal Manipulation
- Keywords
- Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Spinal ManipulationOther
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.
Placebo Thoracic Spinal ManipulationOther
This intervention is a classic method used to evaluate the effect of thoracic spinal manipulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Thoracic Spinal Manipulation; Other: Placebo Thoracic Spinal Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline overall postural stability index immediately after the intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline mediolateral stability index immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start16 Mar 2026
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Dursun, Bitlis Eren University
- Investigators
- ömer dursun, Assoc. Prof., Principal investigator, Bitlis Eren Universityburak mavuş, M.Sc., Principal investigator, Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospitalmerve tunçdemir, Asst. Prof., Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436975
- Sponsor's protocol ID
- BEUFTR-11
- Status last verified
- May 2026
- First submitted
- 22 Feb 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12625651Karthikbabu 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.
PubMed 25624827Duarte 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.
PubMed 12440800Hsieh 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.
PubMed 12411652Verheyden 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.
PubMed 17178824Verheyden 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.
PubMed 16096256Jeong 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.
PubMed 32576744Sunderland 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.
PubMed 2592969Ryerson 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.
PubMed 18463551Langhorne 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.
PubMed 19608100Joo 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 30121128Paris SV. Spinal manipulative therapy. Clin Orthop Relat Res. 1983 Oct;(179):55-61.
PubMed 6225596Cleland 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.
PubMed 15922233Lee 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.
PubMed 23916050Shin 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.
PubMed 27799691
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Spinal Manipulation on Balance, Fall Risk, and Thoracic Mobility in Patients With Chronic Stroke: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07436975
- Acronym / sponsor ID
- BEUFTR-11
- Conditions
- Stroke
- Keywords
- Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 thoracic spinal manipulation and thoracic spinal manipulation interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PlaceboThoracic Spinal Manipulation Group | Placebo comparator | Other: Thoracic Spinal Manipulation, Other: Placebo Thoracic Spinal ManipulationParticipants 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 | Other: Thoracic Spinal Manipulation, Other: Placebo Thoracic Spinal ManipulationParticipants will receive thoracic spinal manipulation in the first session and placebo thoracic manipulation after a one-week washout period. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic Spinal ManipulationThis technique is based on the application of a high-velocity, low-amplitude force to the thoracic spine with the aim of increasing thoracic mobility. | Other | PlaceboThoracic Spinal Manipulation Group, Thoracic Spinal Manipulation Group |
| Placebo Thoracic Spinal ManipulationThis intervention is a classic method used to evaluate the effect of thoracic spinal manipulation. | Other | PlaceboThoracic Spinal Manipulation Group, Thoracic Spinal Manipulation Group |
Primary outcome
Overall Postural Stability Index Measurement
Time frame: Change from baseline overall postural stability index immediately after the intervention
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.
Fall Risk Assessment
Time frame: Change from baseline overall postural stability index immediately after the intervention
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.
3 secondary outcomes
Anteroposterior Stability Index Measurement
Time frame: Change from baseline overall postural stability index immediately after the intervention
Mediolateral Stability Index Measurement
Time frame: Change from baseline mediolateral stability index immediately after the intervention
Thoracic Mobility
Time frame: Change from baseline mediolateral stability index immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 12625651Meijer 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.
- Background: PubMed 25624827Karthikbabu 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.
- Background: PubMed 12440800Duarte 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.
- Background: PubMed 12411652Hsieh 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.
- Background: PubMed 17178824Verheyden 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.
- Background: PubMed 16096256Verheyden 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.
- Background: PubMed 32576744Jeong 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.
- Background: PubMed 2592969Sunderland 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.
- Background: PubMed 18463551Ryerson 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.
- Background: PubMed 19608100Langhorne 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.
- Background: PubMed 30121128Joo 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.
- Background: PubMed 6225596Paris SV. Spinal manipulative therapy. Clin Orthop Relat Res. 1983 Oct;(179):55-61.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ömer dursun, Assoc. Prof. principal investigator
Bitlis Eren University
burak mavuş, M.Sc. principal investigator
Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
merve tunçdemir, Asst. Prof. principal investigator
Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Spinal Manipulation in people with Stroke, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Postural Stability Index Measurement (time frame: Change from baseline overall postural stability index immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07436975, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.