Effects of Stimulated Occlusal Imbalance and Jaw Clenching on Balance and Fall Risk in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Postural Stability Index Measurement
研究概览
简要总结
The aim of the study is to investigate the effects of stimulated occlusal imbalance and jaw clenching on balance and fall risk in patients with stroke.
详细描述
This randomized controlled study will be conducted on a minimum of 42 stroke patients who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to one of three groups: the ipsilateral side stimulated occlusal imbalance group, the contralateral side stimulated occlusal imbalance group, or the bilateral jaw clenching group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The evaluator and the researcher administering intervention will be different.
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,
- •Being between 18 and 75 years of age,
- •Having a Brunnstrom stage of 4 or above,
- •Ability to stand independently for 20 seconds or more,
- •Ability to walk independently for 10 meters, using assistive devices or orthoses if necessary,
- •Having opposing mandibular and maxillary second premolars or first molars
排除标准
- •The presence of severe osteoarthritis in the lower extremity,
- •The presence of cancer or diabetic neuropathy,
- •The presence of vestibular disorder,
- •The presence of lower extremity ulceration or amputation,
- •Hemodynamic instability,
- •The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
- •Having experienced an acute lower extremity injury in the last six weeks,
- •History of lower extremity surgery,
- •Alcohol consumption in the last 24 hours
- •Posterior circulation stroke involving the basilar artery or cerebellum
研究组 & 干预措施
Bilateral Cotton Roll with Jaw Clenching Group
Patients in the bilateral cotton roll with jaw clenching group will clench their teeth while cotton rolls are placed on both sides of the occlusal surfaces.
干预措施: Bilateral Cotton Roll with Jaw Clenching (Other)
Ipsilesional Side Stimulated Occlusal Imbalance Group
In this group, occlusal imbalance will be induced by placing a cotton roll on the ipsilesional occlusal surfaces of the patients.
干预措施: Ipsilesional Side Stimulated Occlusal Imbalance (Other)
Contralesional Side Stimulated Occlusal Imbalance Group
In this group, occlusal imbalance will be induced by placing a cotton roll on the contralesional occlusal surfaces of the patients.
干预措施: Contralesional Side Stimulated Occlusal Imbalance (Other)
结局指标
主要结局
Overall Postural Stability Index Measurement
时间窗: 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 two trials will be automatically calculated by the TechnoBody balance system.
Fall Risk Assessment
时间窗: Change from baseline fall risk 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 two trials will be calculated automatically by the TechnoBody balance system.
次要结局
- Anteroposterior Stability Index Measurement(Change from baseline anteroposterior stability index immediately after the intervention)
- Mediolateral Stability Index Measurement(Change from baseline mediolateral stability index immediately after the intervention)
- Weight Bearing Distribution Assessment(Change from baseline weight bearing distribution immediately after the intervention)
研究者
Omer Dursun
Asst. Prof.
Bitlis Eren University