EUCTR2022-000788-30-PL进行中(未招募)1 期
Evaluation of the effectiveness of Methocarbamol in the treatment ofspasticity in people with spinal cord injury.
zdrowisko Kamien Pomorski S.A.0 个研究点目标入组 30 人开始时间: 2022年9月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •a history of spinal cord injury;
- •the presence of increased muscle tension on the Ashwort scale 2 to 4;
- •time since injury: 3 months;
- •the patient must be circulatory and respiratory efficient, alert and aware; adapted to a vertical position;
- •a patient with complete and incomplete spinal cord injury, in the cervical, thoracic and lumbar spine, in whom the flexion and extension function will be maintained in the elbow and wrist joints;
- •preserved spine stabilization, stabilization of the anastomosis after surgery, completed bone union;
- •no contraindications to rehabilitation, such as thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •the patient's use of a myorelaxant other than methocarbamol;
- •the patient's use of botulinum toxin;
- •tetraplegia;
- •joint contractures preventing rehabilitation with robots and other contraindications to robotic therapy, such as severe osteoporosis, circulatory and respiratory system disorders, skin lesions, thrombophlebitis, pulmonary embolism, orthostatic drops in blood pressure, epilepsy, infection;
- •the presence of open, oozing bedsores;
- •malnutrition, wasting of the body (muscle atrophy of the paralyzed without signs of malnutrition and wasting of the body are not the cause of exclusion);
- •lack of the patient's informed consent;
- •pregnancy or breast-feeding.
研究者
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