Effect of Transcutaneous Auricular Nerve Stimulation vs Body Rocking Exercises on Spasticity of Upper Limb in Young Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale (MAS)
研究概览
简要总结
The primary aim of this study is to compare the effect of TANS and body rocking exercises on reducing upper limb spasticity in young stroke patients( under 50). Specific objectives include evaluating changes in muscle tone, motor function, pain reduction, and functional independence following each intervention.
详细描述
This randomized controlled trial, RCT, will involve 42 young stroke patients with upper limb spasticity randomly assigned to three groups, transcutaneous auricular nerve stimulation, body rocking exercise, or control group, usually rehabilitation. Participants will receive 30-minute transcutaneous nerve stimulation session or 20 to 30-minute body rocking exercise in session 3 to 4 times a week over an 8-week period. Key outcome measures include the Modified Ashworth Scale for Spasticity, the Fusel-Meyer Assessment for Motor Function, the Numeric Rating Scale for Pain, and Stroke Impact Scale for Functional Independence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35-50 years
- •Diagnosed with stroke (ischemic or hemorrhagic)
- •Upper limb spasticity (Modified Ashworth Scale score ≥1)
- •Post-stroke duration of ≥3 months
- •Able to follow verbal and physical instructions
- •No contraindications to electrical stimulation or exercise therapy
排除标准
- •Severe cognitive impairment or communication disorders
- •History of epilepsy or uncontrolled seizures
- •Pacemaker or implanted medical devices
- •Severe cardiac, orthopedic, or neurological conditions
- •Uncontrolled hypertension or diabetes
- •Participation in another spasticity-related trial
研究组 & 干预措施
TANS Group
干预措施: TANS Group (Combination Product)
Body Rocking Exercise
干预措施: Body Rocking Exercise (Combination Product)
结局指标
主要结局
Modified Ashworth Scale (MAS)
时间窗: 12 Months
Assesses spasticity (0 = no increase, 4 = rigid limb).
Fugl-Meyer Assessment (FMA)
时间窗: 12 Months
Evaluates motor function (0-66, higher = better function).
Numeric Rating Scale (NRS)
时间窗: 12 Months
Measures pain (0 = no pain, 10 = severe pain).
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University