FEASIBILITY and PRELIMINARY EFFICACY of REPETITIVE TRANS-SPINAL MAGNETIC STIMULATION for GAIT RECOVERY AFTER INCOMPLETE SPINAL CORD INJURY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 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 assess the feasibility of combining rTsMS with BWSTT for gait and sensorimotor recovery in individuals with incomplete spinal cord injury.
详细描述
A randomized, sham-controlled, triple-blinded and parallel group trial (10 therapeutic sessions). Active or sham rTsMS will be combined with body weight-support treadmill training to verify the improvement of gait and sensory-motor function in patients with incomplete spinal cord injury. Assessments will be performed before, after 5 and 10 therapeutic sessions, 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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed incomplete spinal cord injury established by a neurologist
- •Chronic phase (>1 year)
- •18 and 60 years old, regardless of sex
排除标准
- •Community ambulators
- •Could not maintain an orthostatic position for 30 seconds without assistance
- •Associated neurological and/or orthopedic conditions
- •Contraindications for rTsMS
- •Diagnosis of cardiac dysfunction, angina, or hemodynamic disorders
研究组 & 干预措施
high-frequency rTsMS + BWSTT
a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between high-frequency rTsMS and body weight-support treadmill training in improving the gait and sensory-motor function of adult patients with chronic incomplete spinal cord injury.
干预措施: Repetitive trans-spinal magnetic stimulation (Device)
sham rTsMS + BWSTT
a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between sham rTsMS and body weight-support treadmill training in improving the gait and sensory-motor function of adult patients with chronic incomplete spinal cord injury.
干预措施: Repetitive trans-spinal 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: Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of 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. The higher the score, the greater the independence in gait.
次要结局
- Changes on ASIA Impairment Scale (AIS)(Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).)
- Changes on Spinal cord independence measure (Self-Reported) III - (SCIM-III)(Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).)
- Change from Modified Ashworth scale (MAS)(Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).)
- Changes on Short-Form Health Survey (SF-36)(Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).)
- Changes on Patient Global Impression of Change Scale - (PGICS)(After 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).)
研究者
Fernanda Natacha Rufino Nogueira
Master in Physical Therapy
Universidade Federal de Pernambuco