Development of Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Machine-assisted Bimanual Therapy (BT) in Upper Limb Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether combining repetitive transcranial magnetic stimulation (rTMS) with machine-assisted bimanual therapy (BT) can improve upper limb function in stroke patients. The participants will be individuals aged 40-80 years who have experienced a first-time ischemic or hemorrhagic stroke. The main questions it aims to answer are:
- Does the combined therapy enhance motor recovery compared to traditional rehabilitation methods?
- Are changes in brain activity associated with improvements in upper limb function?
Participants will be randomly assigned to different groups and will:
- Receive rTMS stimulation on specific areas of the brain to modulate neural activity,
- Perform machine-assisted bimanual exercises to promote motor skills, and
- Undergo assessments before, immediately after, and during follow-up periods to measure functional improvements.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years;
- •First-onset stroke patients;
- •Patients diagnosed with cerebral infarction or hemorrhage through CT or MRI;
- •Signed informed consent form by the patient and their family;
- •Stable physiological parameters;
- •Stroke occurred within the last 12 months;
- •Patients with unilateral hand function impairment caused by the stroke;
- •Upper limb muscle tone (Modified Ashworth Scale, MAS) less than 3 points;
- •Able to follow two-step commands.
排除标准
- •A history of epilepsy or family history of epilepsy;
- •Presence of suicidal tendencies;
- •Currently using medications that lower the seizure threshold;
- •Pregnant or planning to become pregnant;
- •Co-existing neurological diseases (such as multiple sclerosis, other neurodegenerative diseases, meningitis, brain abscess, or meningioma);
- •Subjects with uncontrollable migraines caused by elevated intracranial pressure;
- •Subjects taking antidepressants who cannot discontinue the medication;
- •Subjects with sleep disorders during rTMS treatment;
- •Subjects with cerebellar stroke or brainstem stroke;
- •Cerebral ischemic disorders resulting from traumatic brain injury;
- •Transient ischemic attacks (TIAs);
- •History of bleeding tendency and other conditions affecting upper limb function, such as myasthenia gravis, systemic immune neuropathy, severe epilepsy, endocrine system disorders, wearers of external or internal cardiac pacemakers, individuals with metallic implants or orthopedic devices;
- •Co-existing severe heart, liver, kidney dysfunction, or other serious physical illnesses;
- •Subjects with impaired consciousness who cannot cooperate with examinations or treatments, such as those with mental disorders, or those with intellectual or cognitive impairments, severe dementia;
- •Presence of implanted electronic devices in the body;
- •Co-existing severe liver, kidney, or hematological disorders;
- •Special vulnerable populations;
- •Skin disease (e.g., pressure ulcers, trauma, cellulitis, etc.).
研究组 & 干预措施
rTMS-only group
15 mins rTMS and 50 mins conventional occupational therapy
干预措施: Conventional occupation therapy (Other)
Control group
15 mins self-initiated stretching exercise + 50 mins conventional occupational therapy
干预措施: Conventional occupation therapy (Other)
Control group
15 mins self-initiated stretching exercise + 50 mins conventional occupational therapy
干预措施: stretching exercise (Other)
rTMS combined with bimanual therapy group
15 mins therapy (rTMS + bimanual therapy) and 50 mins conventional occupational therapy
干预措施: bimanual therapy (Device)
rTMS-only group
15 mins rTMS and 50 mins conventional occupational therapy
干预措施: rTMS (Other)
rTMS combined with bimanual therapy group
15 mins therapy (rTMS + bimanual therapy) and 50 mins conventional occupational therapy
干预措施: Conventional occupation therapy (Other)
rTMS combined with bimanual therapy group
15 mins therapy (rTMS + bimanual therapy) and 50 mins conventional occupational therapy
干预措施: rTMS (Other)
结局指标
主要结局
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
时间窗: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.
This assessment captures motor recovery across four specific domains: Part A (proximal upper limb-shoulder, elbow, and forearm), Part B (wrist), Part C (hand), and Part D (coordination and speed). The full scale ranges from 0 to 66 and the higher scores represent the better outcome.
次要结局
- Modified Ashworth Scale (MAS)(Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.)
- Upper Extremities Muscle Strength(Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.)
- Action Reach Arm Test (ARAT)(Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.)
- Brunnstrom Recovery Stage(Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.)
- Instrumental Activities of Daily Living Scale (IADLs)(Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.)
- System Usability Scale (SUS)(Administered once immediately after the final intervention session to capture the participant's impressions of the device's usability.)
- Satisfaction Questionnaire(Administered once immediately after the final intervention session to assess participants' subjective satisfaction with the intervention.)