Repetitive Transcranial Magnetic Stimulation Combined to Body Weight-support Treadmill Training in the Sensory-motor Recovery of Patients With Chronic Incomplete Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
研究概览
简要总结
The aim of this study is to verify the efficacy of body weight-support treadmill training combined with high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury.
详细描述
A randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions). Active or sham rTMS will be combined with body weight-support treadmill training to verify the improvement of sensory-motor function in patients with incomplete spinal cord injury. Behavioral assessments will be performed before, after 6 and 12 therapeutic sessions and at the 30-day follow-up after the intervention, though: (i) the WISCI-II Index; (ii) ASIA Impairment Scale (AIS), (iii) ASIA Lower Extremities Motor Scale (LEMS), (iv) Ashworth Modified Scale; (v) the Functional Independence Measure (SCIM-III), (vi) the Short Form Health Survey 36 (SF-36) and (vii) 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, Investigator, 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
- •Presented clinical diagnostic of incomplete thoraco-lumbar spinal cord injury, provided by a neurologist (below the T1 level).
- •Duration injury of at least 8 months.
- •Presented degree of C or D according to the ASIA Impairment Scale (AIS) scale of the American Spinal Cord Injury Association.
- •Patients who are not community walkers.
排除标准
- •Pregnant women;
- •Pacemaker;
- •Historic of seizures;
- •Metallic implants in the head;
- •Patients with clinical evidence of brain injuries;
- •Patients with neurological and / or orthopedic pathologies that have repercussion on a gait and the disadvantages
- •Use of neuroleptic medications.
研究组 & 干预措施
high-frequency rTMS + BWSTT
a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with the combination between body weight-support treadmill training combined and high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury. The sessions will be performed three times a week for a month.
干预措施: High frequency repetitive transcranial magnetic stimulation (Device)
sham rTMS + BWSTT
a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with the combination between body weight-support treadmill training combined and high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury. The sessions will be performed three times a week for a month.
干预措施: Sham High frequency repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
时间窗: (i) Baseline - one day before the intervention, (ii) T0 - after 2 weeks, (iii) T1- after 4 weeks (iv) T2 - 1 month after the end of the intervention.
this is international scale, designed to identify an improvement in the ability to perform gait with spinal cord injury under environmental conditions. The WISCI-II is considered standard for gait evaluation of patients with spinal cord injury inserted in clinical trials. The WISCI-II categorizes patients' ability to perform a gait on 20 different levels by considering the following: distance traveled, need for assistance, assistance from others people, and gait devices.
Changes on ASIA Impairment Scale (AIS)
时间窗: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention.
this is international scale, it is the gold standard for the diagnosis of spinal cord injury and is used worldwide. The AIS categorizes the lesion from full spinal cord injury to normal degree, according to sensory-motor preservation, passing through 3 degrees of spinal cord injury (A , B, C, D or E).
次要结局
- Changes on Spinal cord independence measure (Self-Reported) III (SCIM-III)((i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention)
- Changes on Short-Form Health Survey (SF-36)((i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention)
- Changes on Lower Extremities Motor Scale (LEMS) from ASIA((i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention)
- Change from Modified Ashworth scale (MAS)((i) Baseline - one day before the intervention, (ii) T0 - after 2 weeks, (iii) T1- after 4 weeks (iv) T2 - 1 month after the end of the intervention.)
- Changes on Patient Global Impression of Change Scale - (PGICS)((i)T0 - after 2 weeks, (ii) T1- after 4 weeks and (iii) T2 - 1 month after the end of the intervention.)
研究者
Fernanda Natacha Rufino Nogueira
Bachelor in physical therapy
Universidade Federal de Pernambuco