Effects of Lumbar Spinal Manipulation on Balance and Fall Risk in Patients With Chronic Stroke: A Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The evaluator and the researcher administering the intervention will be different. The interventions will be administered to participants randomly.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Lumbar Spinal Manipulation (Other)
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.
干预措施: Placebo Lumbar Spinal Manipulation (Other)
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.
干预措施: Lumbar Spinal Manipulation (Other)
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.
干预措施: Placebo Lumbar Spinal Manipulation (Other)
研究者
Omer Dursun
Assoc. Prof.
Bitlis Eren University