Effects of Trans-spinal Direct Current Stimulation Combined to Physical Therapy in Patients with Chronic Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in the Upper and Lower Extremities Motor Scale (UEMS and LEMS) from ASIA.
研究概览
简要总结
The aim of this study is to evaluate the effects of tsDCS combined with physical therapy on the recovery of motor function in adult patients with chronic incomplete spinal cord injury.
详细描述
A randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions). Active or sham tsDCS will be combined with physical therapy to verify the improvement of motor function in patients with incomplete spinal cord injury. Assessments will be performed before and after therapeutic sessions and at the 30-day follow-up after the intervention, through: (i) ASIA Lower and Upper Extremities Motor Scale (LEMS and UEMS), (ii) ASIA Impairment Scale (AIS), (iii) Ashworth Modified Scale; (iv) the Functional Independence Measure (SCIM-III), and (v) the Patient Global Impression of Change Scale - (PGICS).
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of incomplete spinal cord injury by a neurologist
- •Diagnosis time greater than 12 months
排除标准
- •Patients with additional current neurological diagnoses
- •Presence of contraindications for tsDCS
研究组 & 干预措施
active tsDCS + physical therapy
a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between physical therapy combinated and active tsDCS in improving the motor function of adult patients with chronic incomplete spinal cord injury. The sessions will be performed five times a week for a month.
干预措施: Trans-spinal direct current stimulation (Device)
sham tsDCS + physical therapy
a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between physical therapy combinated and sham tsDCS in improving the motor function of adult patients with chronic incomplete spinal cord injury. The sessions will be performed five times a week for a month.
干预措施: Trans-spinal direct current stimulation (Device)
结局指标
主要结局
Changes in the Upper and Lower Extremities Motor Scale (UEMS and LEMS) from ASIA.
时间窗: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
It is an international scale. The UEMS and LEMS are composed of the sum of muscle function grading for the five key muscles of the upper and lower limbs (respectively) as defined by ASIA. The score for each muscle is graded from '0' to '5', and the total score can range from '0' to '50'. To calculate this, the scores for the five muscles of each limb (upper and lower/ left and right) should be summed. The higher the score, the better the motor function.
次要结局
- Changes on American Spinal Cord Injury Association - Impairment Scale (AIS)(Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.)
- Changes on Spinal cord independence measure (Self-Reported) III (SCIM-III)(Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.)
- Change from Modified Ashworth scale (MAS)(Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.)
- Changes on Patient Global Impression of Change Scale - (PGICS)(After 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.)
研究者
Fernanda Natacha Rufino Nogueira
Master in Physical Therapy
Universidade Federal de Pernambuco