Efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients: Double Blinded, Randomized and Controlled Clinical
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Spasticity
研究概览
简要总结
In this study, it is being investigated if the association between high frequency repetitive transcranial magnetic stimulation associated with motor physical therapy reduces spasticity, increases upper limb motor function, and quality of life of post-chronic stroke patients than motor physical therapy alone. For this purpose, patients included will be submitted to ten sessions with active or sham hf-rTMS followed by a protocol of physical therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 to 75 years;
- •Both sexes;
- •With diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging;
- •Spasticity grade will be assessed using the Ashworth modified scale (BOHANNON & SMITH, 1987), with score +1, 2 or 3 for the wrist flexors of the affected upper limb;
- •With absence of cognitive deficit verified by the Folstein Mini Mental State Examination (score ≥ 20) modified for the Brazilian population (BRUCKI et al., 2003)
排除标准
- •Contraindications to and EMT (ROSSINI et al., 2015)
- •Clinical evidence of multiple brain lesions
- •Trauma-orthopedic injury that limits the range of motion of the upper limb
- •Presence of visual and / or communication deficit
- •Involvement of other interventions focused on reducing spasticity
- •Modification of medications in the last 30 days.
研究组 & 干预措施
Experimental: hf rTMS and Physical therapy
High frequency TMS will be applied with an eight shaped coil angled at 45 degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1) injured. Forty stimulus trains will be provide at 10Hz over the injured hemisphere, at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 2000 pulses for approximately 20 minutes, with 120% of resting motor threshold (RMT). After TMS, patients will be submitted to 50 minutes of physical therapy protocol.
干预措施: TMS (Device)
Experimental: hf rTMS and Physical therapy
High frequency TMS will be applied with an eight shaped coil angled at 45 degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1) injured. Forty stimulus trains will be provide at 10Hz over the injured hemisphere, at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 2000 pulses for approximately 20 minutes, with 120% of resting motor threshold (RMT). After TMS, patients will be submitted to 50 minutes of physical therapy protocol.
干预措施: Physical therapy (Other)
Control: Sham hf rTMS and Physical theraphy
In this group, the volunteer will start with sham TMS, will be the same parameters was used in experimental group, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. After, the volunteer will be submitted to 50 minutes of physical therapy protocol.
干预措施: TMS (Device)
Control: Sham hf rTMS and Physical theraphy
In this group, the volunteer will start with sham TMS, will be the same parameters was used in experimental group, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. After, the volunteer will be submitted to 50 minutes of physical therapy protocol.
干预措施: Physical therapy (Other)
结局指标
主要结局
Spasticity
时间窗: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Change from degree of Spasticity: ordinal variable measured through the Ashworth Modified Scale, expressed as scores graded from +1 to 3. The EMA is a qualitative instrument with ordinal measures that scores the degree of spasticity presented by the resting muscle from zero to four, in increasing order of intensity.
次要结局
- Cortical excitability(before and after 10 daily sessions and after 30 days)
- Quality of life(before and after 10 daily sessions and after 30 days)
- Qualitative and quantitative of moviment(before and after 10 daily sessions and after 30 days)
- Changes on Patient Global Impression of Change Scale(before and after 10 daily sessions and after 30 days)
- Variation of the median nerve Hmax / Mmax ratio(before and after 10 sessions and after 30 days)
- Sensory-motor function of the upper limb(before and after 10 daily sessions and after 30 days)
- Dynamometry(before and after 10 daily sessions and after 30 days)
研究者
Kátia Monte-Silva
principal investigator
Universidade Federal de Pernambuco