Demonstration the Importance of the Early Rehabilitation in Stroke Patients Based on Diffüsion Tensor Imaging Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Change in Cranial diffusion tractography
研究概览
简要总结
Stroke is one of the leading health problems in the community and it is the most common life-threatening neurological disease impairing the quality of life. Early rehabilitation of stroke is very important. The purpose of our study was to evaluate, through clinical examination, whether there was any difference between patients who underwent early rehabilitation and those who underwent late rehabilitation in terms of improvements in motor and functional impairment after rehabilitation, and also to evaluate this difference objectively by analyzing white-matter pathways (corticospinal tracts) using DTI.
详细描述
Methods: Twenty-eight (28) adults (12 women, 16 men, average age 58 years) with first-time stroke who met the study criteria were divided into two groups depending on the duration of their stroke at the time of their presentation to our facility. Group 1 consisted of patients who underwent rehabilitation program within the first 1-4 weeks after stroke, whereas Group 2 consisted of patients who underwent rehabilitation program within 5-8 weeks after stroke. Both groups were evaluated using the BRS, FMA scale, FAC and BI scales. For cranial imaging, DTI was obtained 1 day before and 1 day after treatment. FA and ADC values of corticospinal tracts were performed using DTI.
Intervention: Patients were enrolled in a rehabilitation program, which was designed for a total of 4 weeks, with daily sessions lasting a total of 1 h on 5 days of a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The clinician evaluating the patient and the radiologist evaluating the MRI were blinded to the groups.
入排标准
- 接受健康志愿者
- 否
入选标准
- •Patients suffering cerebrovascular accident (CVA)-associated stroke for the first time with a cortical or subcortical unilateral ischemia or hemorrhage
- •The patients aged 35-75 years
- •Patiients with ability to understand and follow the instructions
- •Patients with the absence of serious cognitive deficits.
排除标准
- •Patients who had spinal-cord lesion
- •Patients who had history of traumatic brain injury,
- •Patients who had accompanying neurological disease (multiple sclerosis, Parkinson's disease, dementia)
- •Patients who had tumor
- •Patients who had history of convulsions
研究组 & 干预措施
group 1
Group 1:Early rehabilitation
干预措施: Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data (Other)
group 2
Group 2:Late rehabilitation
干预措施: Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data (Other)
结局指标
主要结局
Change in Cranial diffusion tractography
时间窗: performed 1 day before and 1 month after treatment
Diffusion tensor imaging (DTI) is based on determining tissue structure by measuring diffusion rate and direction of movement of water molecules in vivo. DTI is the only in vivo method of mapping white-matter pathways in the human brain. Tractography is the technique for mapping white-matter structure with DTI data
Change in Fugl-Meyer Assessment Scale score(FMA)
时间窗: performed 1 day before the end of the second week of the treatment and 1 day after the completion of the treatment
FMA is a stroke-specific, performance-based impairment index. (0 point : Flaccid paralysis 100points=Normal).
次要结局
未报告次要终点
研究者
Yaşar Keskin
Principal Investigator at Department of Physical Medicine and Rehabilitation at Bezmialem Vakif University, Medical Doctor
Bezmialem Vakif University