- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07619586
Lumbar Spinal Manipulation in Stroke
2026년 6월 13일 업데이트: Omer Dursun, Bitlis Eren University
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
52
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: burak mavuş, M.Sc.
- 전화번호: +90 5388178351
- 이메일: a.burakmavus@gmail.com
연구 연락처 백업
- 이름: Ömer Dursun, Assoc. Prof.
- 전화번호: 05426088687
- 이메일: fztomrdrsn@gmail.com
연구 장소
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Bolu, Merkez
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Bolu, Bolu, Merkez, 터키 (Türkiye), 14280
- Bolu İzzet Baysal Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
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연락하다:
- Birkan Özkardaş, Mr.
- 전화번호: +90 5550639585
- 이메일: brknzkrds31@gmail.com
-
연락하다:
- burak mavuş, M.Sc.
- 전화번호: +90 5388178351
- 이메일: a.burakmavus@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Placebo Comparator: Placebo Lumbar Spinal Manipulation Group
Participants will receive placebo lumbar spinal manipulation in the first session and lumbar spinal manipulation after a washout period.
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This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility.
This intervention is a classic method used to evaluate the effect of lumbar spinal manipulation.
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활성 비교기: Active Comparator: Lumbar Spinal Manipulation Group
Participants will receive lumbar spinal manipulation in the first session and placebo lumbar spinal manipulation after a washout period.
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This technique is based on the application of a high-velocity, low-amplitude force to the lumbar spine with the aim of increasing mobility.
This intervention is a classic method used to evaluate the effect of lumbar spinal manipulation.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Postural Stability Index Measurement
기간: Change from baseline overall postural stability index immediately after the intervention
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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.
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Change from baseline overall postural stability index immediately after the intervention
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Fall Risk Assessment
기간: Change from baseline fall risk immediately after the intervention
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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.
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Change from baseline fall risk immediately after the intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anteroposterior Stability Index Measurement
기간: Change from baseline anteroposterior postural stability index immediately after the intervention
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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.
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Change from baseline anteroposterior postural stability index immediately after the intervention
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Mediolateral Stability Index Measurement
기간: Change from baseline mediolateral stability index immediately after the intervention
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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.
|
Change from baseline mediolateral stability index immediately after the intervention
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: burak mavuş, M.Sc., Bolu Abant İzzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
- 수석 연구원: merve tunçdemir, Asst. Prof., Bitlis Eren University
- 수석 연구원: Ömer DURSUN, Assoc. Prof., Bitlis Eren University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- Arene 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.
- Speelman 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 15일
기본 완료 (추정된)
2026년 12월 15일
연구 완료 (추정된)
2026년 12월 15일
연구 등록 날짜
최초 제출
2026년 5월 26일
QC 기준을 충족하는 최초 제출
2026년 5월 26일
처음 게시됨 (실제)
2026년 6월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 13일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .