Pilot Randomized Controlled Trial Assessing Associative Peripheral Stimulation (APS) for Reduction of Motor Impairment During Acute Period of Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Fugl-Meyer Assessment Upper-Extremity (FMA-UE)
研究概览
简要总结
Associative Peripheral Stimulation (APS) is a non-invasive therapy intended for stroke rehabilitation involving transcutaneous electrical muscle stimulation paired with voluntary movement. This pilot study investigates whether APS applied during the acute phase of stroke recovery may reduce impairment and improve function in the affected upper extremity.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed ischemic or hemorrhagic stroke no earlier than 7 days prior to enrollment;
- •Presentation of hemiparesis or paralysis of the upper extremity due to stroke;
- •Ability to comprehend and follow study instructions;
- •Ability to initiate finger extension (≥3°) at least three times per minute;
- •Fugl-Meyer Assessment (Upper Extremity) score of <47.
排除标准
- •Contraindications, intolerance, or high sensitivity to the experimental protocol;
- •History of upper-extremity disability prior to the index stroke;
- •Neurological conditions (other than stroke) affecting motor function;
- •Treatment of spasticity/increased tone in the affected upper extremity (e.g., with Botox injection);
- •Lack of access to a safe and suitable place of discharge for experimental sessions and follow-up visits.
结局指标
主要结局
Fugl-Meyer Assessment Upper-Extremity (FMA-UE)
时间窗: 5 weeks
Measure of motor recovery in stroke patients with hemiparesis. Scoring range: 0 to 66. Higher scores indicate better outcomes.
Maximum Average of Range of Motion (ROM)
时间窗: 5 weeks
Measure of distal extensor function (wrist and fingers). Unit of measurement: degrees (°). Higher scores indicate better outcomes.
次要结局
- Fugl-Meyer Assessment Upper-Extremity (FMA-UE)(3 months)
- Action Research Arm Test (ARAT)(3 months)
- Maximum Average of Range of Motion (ROM)(3 months)
研究者
Ahmed A. Rahim
Sponsor-Investigator
APS Trial Group