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临床试验/NCT06826976
NCT06826976Enrolling By Invitation不适用

Influence of Sensory Electrical Stimulation on Hand Functions in Chronic Stroke Patients

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
Hand grip strength

研究概览

简要总结

This study investigates the impact of sensory electrical nerve stimulation (SENS) on hand function in chronic stroke patients. Thirty participants were randomly divided into two groups:

Study Group (A): Received SENS combined with task-specific training.

Control Group (B): Received only task-specific training.

Assessments conducted before and after the intervention included measurements of grip strength, pinch strength, wrist range of motion, and performance on the Action Research Arm Test (ARAT).

详细描述

This study explores the effectiveness of sensory electrical nerve stimulation (SENS) in enhancing hand function among chronic stroke patients. Thirty participants were randomly divided into two groups:

Study Group (A): Received SENS combined with task-specific training.

Control Group (B): Received only task-specific training.

Assessment Methods:

Before and after the intervention, both groups underwent evaluations using:

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
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who have experienced their first-ever ischemic stroke in the carotid system domain.
  • •Age range: 40 to 65 years old.
  • •Duration of illness: 30 to 180 days since stroke onset.
  • •Spasticity of the affected hand muscles (wrist flexors, finger flexors, and finger adductors) must be grade 1+ or less according to the Modified Ashworth Scale.
  • •Hand dysfunction severity ranges from mild to severe, defined by a score of ≤ 4 on the Medical Research Council Scale.

排除标准

  • •Presence of a deformity in the paralytic upper limb before the stroke.
  • •History of a lower motor neuron lesion in the impaired upper extremity (e.g., polyneuropathy) before the stroke.
  • •Skin abrasions or ulcerations on the affected upper limb.
  • •Unstable health conditions, including cardiac dysfunction, end-stage renal failure, unstable diabetes, or uncontrolled hypertension (>190/110).
  • •Presence of a pacemaker or other implanted electrically sensitive devices.
  • •Significant orthopedic conditions or chronic pain syndromes.
  • •Chronic use of medications that may influence motor or sensory excitability (e.g., anti-epileptic or antipsychotic drugs).
  • •Pregnancy.

研究组 & 干预措施

Sensory electrical stimulation

Experimental

received sensory electrical stimulation and task specific training program

干预措施: sensory electrical stimulation (Other)

Task specific training

Active Comparator

received task specific training program only. Patients were tested pre and post treatment by Grip dynamometer, Pinch dynamometer, Digital goniometer and Action Research Arm Test Scale (ARAT).

干预措施: task specific training program (Other)

结局指标

主要结局

Hand grip strength

时间窗: From enrollment to the end of treatment at end of 4th week

The patient seated with his/her shoulder adducted and naturally rotated, elbow flexed at 90 degrees, forearm in neutral position, and wrist between 0- and 30-degrees dorsiflexion and between 0- and 15-degrees ulnar deviation. The Jamar hand dynamometer was set to the second handle position from the inside. Lightly hold around the readout dial to prevent inadvertent dropping. After the patient was positioned properly, the following statement was used "Squeeze as hard as you can.... harder .... harder.... relax" (16). The scores of three successive trials were recorded for each tested hand. The average score of three trials was compared to the normative data on the other side, which is in pounds.

wrist range of motion

时间窗: From enrollment to the end of treatment at end of 4th week

Goniometer was used to assess wrist flexion-extension.

pinch strength

时间窗: From enrollment to the end of treatment at end of 4th week

Three types of pinches were typically evaluated because they are involved in accomplishing occupational tasks and activities efficiently. In Tip Pinch: The patient pinched the ends of the pinch meter between the tips of the thumb and index finger. The test was administered by first giving the patient instructions and a demonstration, "Ready? Pinch as hard as you can." The patient was urged on as he or she attempted to pinch. The average of three trials was recorded. In Lateral Pinch (Key Pinch): The patient pinched the meter between the pad of the thumb and the lateral surface of the index finger. In Palmar Pinch (Three-Jaw Chuck): The patient pinched the meter between the pad of the thumb and the pads of the index and middle fingers

hand functions

时间窗: From enrollment to the end of treatment at end of 4th week

Patients who achieve a maximum score on the first (most difficult) item are credited with having scored 3 on all subsequent items on that scale. If the patient scores less than 3 on the first item, then the second item is assessed. This is the easiest item, and if patients score 0 then they are unlikely to achieve a score above 0 for the remainder of the items and are credited with a zero for the other items. The maximum score on ARTS is 57 points (possible range 0 to 57).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Islam Hassan Fayed

Assistant Professor

Cairo University

研究点 (1)

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