The Effect of Talocrural Joint Manipulation on Static Balance in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Overall Stability Index Measurement
研究概览
简要总结
The primary aim of the study is to investigate the effect of talocrural joint manipulation on the static balance of patients with stroke. The secondary aim of this study is to investigate the effect of talocrural joint manipulation on the dorsiflexion range of motion of patients with 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 talocrural joint manipulation and talocrural joint manipulation treatments.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Two months or longer elapsed since the stroke,
- •2. A Mini-Mental State Examination score of 24 or higher,
- •3. The ability to stand independently for 20 seconds or more,
- •4. The ability to walk independently for 10 meters with the use of walking aids or orthoses if necessary,
- •5. Being between 45 and 75 years of age,
- •6. Having a Brunnstrom stage of 4 or above
排除标准
- •1. The presence of severe osteoarthritis in the lower extremity,
- •2. The presence of cancer or diabetic neuropathy,
- •3. The presence of vestibular disorder,
- •4. The presence of lower extremity ulceration or amputation,
- •5. History of vertigo,
- •6. Alcohol consumption within the last 24 hours,
- •7. Hemodynamic instability,
- •8. Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum,
- •9. The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
- •10. Having experienced an acute lower extremity injury in the last six weeks,
- •11. History of lower extremity surgery
结局指标
主要结局
Overall Stability Index Measurement
时间窗: Change from baseline overall stability immediately after intervention
Overall stability index, evaluated using the Biodex Balance System. Overall stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior and mediolateral axes by the device. A lower score indicates smaller deviation and better postural stability. The assessment was conducted on a stable platform with three 20-second repetitions interspersed with 10-second rest periods. Participants remained standing during the rest periods, and the device automatically computed the average of the three repetitions. As the general stability index value increases, overall stability decreases. No definable minimum or maximum theoretical value.
Overall Stability Index Measurement
时间窗: Change from baseline overall stability immediately after intervention
Overall stability index, evaluated using the Biodex Balance System. Overall stability index scores were derived from calculations of deviations from the center of gravity in the anteroposterior and mediolateral axes by the device. A lower score indicates smaller deviation and better postural stability. The assessment was conducted on a stable platform with three 20-second repetitions interspersed with 10-second rest periods. Participants remained standing during the rest periods, and the device automatically computed the average of the three repetitions. As the general stability index value increases, overall stability decreases. No definable minimum or maximum theoretical value.
次要结局
- Mediolateral Stability Index Measurement(Change from baseline mediolateral stability immediately after intervention)
- Anteroposterior Stability Index Measurement(Change from baseline anteroposterior stability immediately after intervention)
- Mediolateral Stability Index Measurement(Change from baseline mediolateral stability immediately after intervention)
- Anteroposterior Stability Index Measurement(Change from baseline anteroposterior stability immediately after intervention)
- Ankle Dorsiflexion Range of Motion Measurement With Knee in Extended and Flexed Positions(Change from baseline ankle dorsiflexion range of motion immediately after intervention)
研究者
Omer Dursun
Asst. Prof.
Bitlis Eren University