Effect of the Vojta Therapy on Lipid Biomarkers Related to Myelin in Subjects With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Balance
研究概览
简要总结
Multiple sclerosis is the most common disabling neurological disease in young adults. Inflammation, demyelination, neurodegeneration, gliosis and repair processes are involved in its process, which are responsible for the heterogeneity and individual variability in the expression of the disease, the prognosis and the response to treatment. Clinically, MS manifests itself with the following symptoms: sensory focus, motor focus, spasticity, balance disorders, visual disturbances such as loss of vision or double vision or sphincter dysfunction.
The main subtypes of MS are relapsing-remitting, secondary progressive, primary progressive, and progressive relapsing. Clinically, RRMS presents the initial inflammatory phase, characterized by reversible flares with neurological dysfunction, followed by periods of remission. Approximately 40-50% of these patients progress to SPMS, where the disease gradually progresses from intermittent flare-ups to steadily progressive worsening, resulting in permanent disability due to massive axonal loss. PPMS is the most severe subtype, affecting approximately 10% of all cases, and manifesting as progressive degeneration without any remission.
详细描述
From the field of Physiotherapy, one of the main tools for the treatment of MS is physical exercise. Numerous studies show that exercising is safe and beneficial in people with MS, as long as it is done correctly and supervised by health professionals. Physical exercise is considered an important part of symptomatic and supportive treatment for people with MS, since it induces improvement of physiological functions affected by lack of physical activity and helps to manage some symptoms, such as spasticity, fatigue and lack of balance There are therapies within Physiotherapy that help treat MS such as the Vojta Method and the Bobath Method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Our population will be subjects diagnosed with MS. Prior to the study, the informed consent will be presented to the subjects. Said confidentiality will be contemplated in Organic Law 15/99 of December 13 on the Protection of personal data.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons with MS who have signed the informed consent.
- •Persons of both sexes.
- •Ages between 20 and 65 years.
- •Subjects of both sexes diagnosed with multiple sclerosis on the EDSS (Expanded Disability Status Scale).
排除标准
- •Persons with multiple sclerosis with EDSS scale score equal to or greater than 7.
- •Occurrence of a flare during the period of the patient's participation in the study.
- •Pregnant women.
- •Oncology patients.
- •Non-acceptance and non-signing of informed consent.
- •Refusal to participate in the study.
- •Patients with severe cognitive impairment that does not allow them to understand the development of the study.
- •Patients with cardiovascular instability.
- •Patients who do not complete at least 75% of the scheduled sessions. Patients who do not present any of the contraindications contemplated for Vojta therapy.
结局指标
主要结局
Balance
时间窗: 10 minutes
The balance will be measured through the Berg scale.
Age
时间窗: 1 minutes
Time reaction
时间窗: 5 minutes
Reaction time will be measured by the Cognifit test
Respiratory function
时间窗: 5 minutes
Respiratory function will be assessed with a pressure manometer to measure peak inspiratory pressure.
Spasticity
时间窗: 10 minutes
Spasticity will be measured using the Tardieu scale.
次要结局
- Myelin(15 minutes)
研究者
Aymara Abreu Corrales
Principal investigator
Instituto de Neurociencia de Castillas y Leon