Effectiveness of Transcranial Magnetic Stimulation Treatment in Patients Diagnosed With Postpolio Syndrome: A Randomized Controlled Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- 6 minute walk test
研究概览
简要总结
This randomized, double-blind, sham-controlled trial evaluated the effects of low-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex on walking capacity, fatigue, post-polio-related symptoms, and health-related quality of life in participants with post-polio syndrome.
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, Outcomes Assessor)
盲法说明
Participants and outcome assessors were blinded. The investigator administering stimulation was aware of allocation because of coil orientation.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with PPS (postpolio syndrome) -Having not received TMS treatment before
排除标准
- •History of epilepsy
- •Presence of another disease that may be associated with the symptoms
- •Inability to ambulate independently
- •Presence of a neurological, psychiatric or vision-related problem that may prevent the patient from answering the questionnaires
- •Presence of ferromagnetic material implanted in the body
- •Organic brain pathology (vascular, traumatic, tumoral, etc.)
- •History of use of drugs that lower the seizure threshold (if not receiving antiepileptic treatment)
- •Severe or recent heart disease
- •Alcoholism
- •Pregnancy
研究组 & 干预措施
Sham rTMS
Sham stimulation followed the same treatment schedule as active rTMS, with the coil reversed and the device operated at minimum output, providing auditory input without effective cortical stimulation. Ten sessions were administered over 2 weeks. All participants received an individualized home exercise program based on limb involvement and muscle strength. Resistive exercise was limited to muscle groups graded at least 3/5 on manual muscle testing and was prescribed according to energy-conservation principles.
干预措施: Sham rTMS (Drug)
Sham rTMS
Sham stimulation followed the same treatment schedule as active rTMS, with the coil reversed and the device operated at minimum output, providing auditory input without effective cortical stimulation. Ten sessions were administered over 2 weeks. All participants received an individualized home exercise program based on limb involvement and muscle strength. Resistive exercise was limited to muscle groups graded at least 3/5 on manual muscle testing and was prescribed according to energy-conservation principles.
干预措施: Individualized home exercise program (Behavioral)
Active rTMS
Active rTMS was delivered using a Magstim Rapid2 stimulator and a figure-of-eight D70 coil (Magstim Company Ltd, Whitland, United Kingdom). The target was the lower-extremity representation of the primary motor cortex near the vertex. Stimulation was delivered at 80% of resting motor threshold, at 1 Hz for 20 minutes (1200 pulses per session), over 10 sessions in 2 weeks. All participants received an individualized home exercise program based on limb involvement and muscle strength. Resistive exercise was limited to muscle groups graded at least 3/5 on manual muscle testing and was prescribed according to energy-conservation principles.
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Device)
Active rTMS
Active rTMS was delivered using a Magstim Rapid2 stimulator and a figure-of-eight D70 coil (Magstim Company Ltd, Whitland, United Kingdom). The target was the lower-extremity representation of the primary motor cortex near the vertex. Stimulation was delivered at 80% of resting motor threshold, at 1 Hz for 20 minutes (1200 pulses per session), over 10 sessions in 2 weeks. All participants received an individualized home exercise program based on limb involvement and muscle strength. Resistive exercise was limited to muscle groups graded at least 3/5 on manual muscle testing and was prescribed according to energy-conservation principles.
干预措施: Individualized home exercise program (Behavioral)
结局指标
主要结局
6 minute walk test
时间窗: 2 weeks
It is a test used to assess the level of functional exercise or functional capacity. The patient is asked to walk, but not run, in a 25 m long corridor at the highest possible speed without stopping. At the end of 6 minutes, the number of metres walked by the patient is recorded. The 6 min walk test is an evaluation criterion used in routine and clinical research to assess functional capacity in many diseases such as heart failure, general arthrosis, multiple sclerosis.
6 minute walk test (6MWT)
时间窗: Baseline, immediately after treatment, and 3-month follow-up
It is a test used to assess the level of functional exercise or functional capacity. The patient is asked to walk, but not run, in a 25 m long corridor at the highest possible speed without stopping. At the end of 6 minutes, the number of metres walked by the patient is recorded. The 6 min walk test is an evaluation criterion used in routine and clinical research to assess functional capacity in many diseases such as heart failure, general arthrosis, multiple sclerosis.
次要结局
- Self-reported ımpairments in persons with late effects of polio (SIPP) rating scale(2 weeks)
- Nottingham health profile (NHP)(2 weeks)
- Visual analogue scale (VAS) for pain and fatigue(2 weeks)
- Manual muscle testing (MMT)(2 weeks)
- Fatigue Impact Scale (FIS)(2 weeks)
- Beck Depression Scale(2 weeks)
- Polio-Related Problems Scale (PRPS)(Baseline, immediately after treatment, and 3-month follow-up)
- Nottingham health profile (NHP)(Baseline, immediately after treatment, and 3-month follow-up)
- Visual analogue scale (VAS) for pain and fatigue(Baseline, immediately after treatment, and 3-month follow-up)
- Manual muscle testing (MMT)(Baseline, immediately after treatment, and 3-month follow-up)
- Fatigue Impact Scale (FIS)(Baseline, immediately after treatment, and 3-month follow-up)
- Beck Depression Inventory (BDI)(Baseline, immediately after treatment, and 3-month follow-up)