Effects of Underwater Electrical Faradic Stimulation on Hand Grip Strength and Upper Extremity Motor Recovery in Sub-acute Post-Stroke Patients: A Double-Blinded, Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Hand Grip Strength (HGS)
研究概览
简要总结
This study evaluates the therapeutic effects of underwater electrical faradic stimulation delivered via a four-cell hydrotherapy bath on hand grip strength and upper limb motor recovery in subacute post-stroke hemiplegic patients.
详细描述
Upper extremity motor impairment remains a major cause of persistent disability following subacute stroke. Forty-four participants with subacute post-stroke hemiparesis were recruited and randomized in a 1:1 ratio to either an experimental group or a placebo control group. Both groups received 12 treatment sessions across 4 consecutive weeks (3 sessions per week, 20 minutes per session). Group A received active underwater faradic current stimulation applied to the affected upper limb in a four-cell hydrotherapy bath. Group B underwent identical limb positioning and bath immersion with 0 mA current output. Hand grip strength (HGS) via Jamar dynamometry and motor function via the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) were assessed at baseline and post-intervention.
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)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever ischemic or hemorrhagic stroke in the subacute phase (<6 months post-onset) confirmed by neuroimaging (CT or MRI).
- •Chronological age ranging from 50 to 65 years.
- •Gross Motor Function Classification System (GMFCS) Level I or II (capable of walking 10 meters independently without physical support or handheld mobility aids).
排除标准
- •Severe cognitive impairments or receptive language deficits precluding the ability to follow verbal instructions or communicate with research staff.
- •Concurrent participation in other interventional clinical trials.
- •Prior history of other neurological, severe musculoskeletal, or psychiatric disorders affecting upper limb function.
- •Presence of skin lesions, open wounds, or severe peripheral vascular disease in the affected upper extremity.
研究组 & 干预措施
Placebo Control Group
Sham Hydrotherapy: Identical positioning and immersion in 4-cell hydrotherapy bath for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Device display active, output amplitude maintained at 0 mA.
干预措施: Placebo (Other)
4-cell Hydrotherapy Bath
Underwater Faradic Stimulation: 4-cell hydrotherapy bath immersion for 20 mins/session, 3 days/week for 4 weeks (12 sessions total). Waveform: Faradic; Pulse Duration: 0-500 µs; Pulse Frequency: 20-50 Hz; Duty Cycle: 2.5s ON / 2.5s OFF; Peak Amplitude: Up to 100 mA (motor threshold).
干预措施: 4-cell Hydrotherapy Bath (Other)
结局指标
主要结局
Hand Grip Strength (HGS)
时间窗: Baseline (T0) and Post-treatment at 4 weeks (T1)
Measurement Tool: Jamar hydraulic hand dynamometer. Unit of Measure: Kilograms (kg). Description: Maximal voluntary contraction (MVC) measured following ASHT guidelines (average of three trials).
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
时间窗: Baseline (T0) and Post-treatment at 4 weeks (T1)
Measurement Tool: FMA-UE Motor Subscale (33 items). Unit of Measure: Ordinal scale score (Range: 0 to 66 points). Description: Evaluates reflex activity, volitional movement, wrist stability, hand grasp, and coordination.
次要结局
未报告次要终点