StrokeNCT07619586
Lumbar Spinal Manipulation in Stroke
A study testing Lumbar 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 lumbar spinal manipulation on balance and fall risk of the patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Lumbar Spinal Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2026to 15 Mar 2027
- Phase
- Interventional
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 18 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,
- 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)
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Bolu, Bolu, Merkez, 14280
Burak Mavuş, M.Sc., 5388178351 ext. +90, a.burakmavus@gmail.com
Birkan Özkardaş, Mr., 5550639585 ext. +90, brknzkrds31@gmail.com
About this study
Official title: Effects of Lumbar Spinal Manipulation on Balance and Fall Risk in Patients With Chronic Stroke: A Randomized Crossover Trial
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.
- Conditions
- Stroke
- Being tested
- Lumbar Spinal Manipulation, Placebo Lumbar 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.
Lumbar Spinal ManipulationOther
This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility.
Placebo Lumbar Spinal ManipulationOther
This intervention is a classic method used to evaluate the effect of lumbar spinal manipulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Lumbar Spinal Manipulation; Other: Placebo Lumbar 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 three 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 three 30-second trials. The average of the three trials will be calculated automatically by the TechnoBody balance system.
Measured: Change from baseline fall risk immediately after the intervention
Secondary outcomes (2)
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.
Measured: Change from baseline anteroposterior 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 three 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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 lumbar spinal manipulation and lumbar 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
- 52 participants (estimated)
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 UniversityMerve Tunçdemir, Asst. Prof., Principal investigator, Bitlis Eren UniversityBurak Mavuş, M.Sc., Principal investigator, Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619586
- Sponsor's protocol ID
- BEUFTR-12
- Status last verified
- Oct 2026
- First submitted
- 26 May 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 22233167Speelman 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 21750523Wenning 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 10584668Arene 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 19903653Lamb 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 12574566Tyson 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 16386060Yates 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 12173758Divani 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 19628798Khalifeloo 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 29740561Chen 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 25133141Pollock 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 24756870Geurts 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 16214666Chen 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 39940031Park 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 35759843Dursun 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