Cerebello-spinal Direct Current Stimulation Associated with Treadmill Gait Training in Functional Mobility in Patients with Parkinsons Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Timed Up and Go
研究概览
简要总结
Parkinsons disease is a progressive neurological disorder marked by a decline in the efficacy of dopaminergic synapses in the nigrostriatal pathway, causing motor disturbances. Resting tremor, bradykinesia, and muscle rigidity are the most prominent motor features. These factors result in gait impairments, including slowness and freezing. The primary treatment for the disease is medication. However, while medication does reduce motor symptoms, prolonged usage may lead to an increase of dyskinesias and a worsening of a patients clinical condition. Thus, alternative therapies, such as cerebellospinal direct current stimulation (csDCS), have gained popularity. Studies suggest that csDCS may be an effective approach to mitigate gait disorders in this patient population. Kinesiotherapy is an established therapeutic method that has been demonstrated to promote functional mobility and improve gait. To date, the combination of kinesiotherapy and csDCS has not been tested, thus the purpose of this study is to evaluate the effectiveness of this combined therapy for enhancing functional mobility in Parkinsons disease patients. The goal of this study is to assess the efficacy of blending csDCS and kinesiotherapy for improving patients functional mobility in Parkinsons disease. Two groups of volunteers will be assigned: i) actual csDCS + kinesiotherapy, and ii) sham csDCS + kinesiotherapy. The full procedure involves 10 therapy sessions conducted across two weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a clinical diagnosis of PD provided by a neurologist
- •regular dopaminergic drug treatment (at least three months of use)
- •aged 40 years or over
- •staging I to IV on the modified Hoehn and Yahr scale
排除标准
- •other neurological disorders, postural hypotension, vestibular, musculoskeletal or visual disorders that compromise performance in the proposed tests
- •other osteoarticular diseases in the lower limbs that interfere with performance and locomotion
- •a Montreal Cognitive Assessment (MoCA) score of less than 21 points
- •have undergone previous surgery for PD
研究组 & 干预措施
csDCS
干预措施: cerebello-spinal direct current stimulation (Device)
csDCS sham
干预措施: sham cerebello-spinal direct current stimulation (Device)
结局指标
主要结局
Timed Up and Go
时间窗: From enrollment to the end of treatment at 4 weeks
For the TUG, the time taken by the patient to perform a task involving standing up from a chair, walking, and sitting back down is measured. The test begins with the patient seated in a chair with their back against the backrest. Upon request, the patient stands up, walks three meters at their fastest yet safe pace, turns around, returns to the chair, and sits down. Shorter times in completing this task indicate better functional mobility. Three repetitions of the test were recorded, and for analysis purposes, the average of the repetitions was used.
次要结局
- Five times sit to stand test(From enrollment to the end of treatment at 4 weeks)
- Mini balance evaluation system test(From enrollment to the end of treatment at 4 weeks)
- Unified Parkinson Disease Rating Scale-II and Scale-III(From enrollment to the end of treatment at 4 weeks)
- Freezing of gait questionnaire(From enrollment to the end of treatment at 4 weeks)
- Six minute walking test(From enrollment to the end of treatment at 4 weeks)
研究者
Kátia Monte-Silva
Doctor professor
Universidade Federal de Pernambuco