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临床试验/NCT06454331
NCT06454331已完成不适用

Effects of Transcranial Direct Cranial Stimulation on Upper Limb Function and Quality of Life in Stroke Patients

Riphah International University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Action Research Arm Test

研究概览

简要总结

Research on the effects of Anodal transcranial Direct Current Stimulation (tDCS) on hand dexterity and quality of life in stroke patients is limited. While the highlighted article focuses on Parkinson's disease, it underscores anodal tDCS potential to modulate brain activity and promote neural plasticity, suggesting potential relevance to stroke rehabilitation

详细描述

tDCS seems like a hopeful way to help stroke patients improve their upper limb function, but there are still some problems and questions that need to be answered. Previous studies have investigated the impact of (tDCS) on upper limb recovery among stroke patients. However, evidence is scarce on the effect of tDCS on hand dexterity and quality of life in stroke patients. Furthermore, these studies have not adequately explored how the severity of stroke influences the efficacy of tDCS on upper limb motor recovery. Additionally, there is a lack of research examining the cumulative effects of tDCS on both upper limb motor recovery and hand dexterity, as well as QoL, particularly concerning stroke severity.

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

  • •Stroke for more than 6 months.
  • •Age 40-80 years
  • •Both gender
  • •National Institutes of Health Stroke Scale (NIHSS) for severity level (Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)

排除标准

  • •Any patient with Upper limb amputation on the effected side, contracture, burn injury that leads to joint limitation and functional limitation.
  • •Known cases of Multiple Sclerosis and Parkinson and any Musculoskeletal disorder and Cardiopulmonary disorder.
  • •Any patient with Metallic implants
  • •Individuals with a history of seizures or epilepsy
  • •Individuals with Skin allergies on the scalp

研究组 & 干预措施

Active tDCS

Experimental

The dosage of anodal tDCS will be 20 minutes with an intensity of 2mA. It's administered before exercise therapy sessions over a period of 8 weeks and 3 times a week

干预措施: Transcranial direct current stimulation (Device)

Sham tDCS Group

Sham Comparator

sham tDCS, task-oriented training (i.e. placing cones on another cone, inserting needles into a box

干预措施: Sham transcranial direct current stimulation (Device)

结局指标

主要结局

Action Research Arm Test

时间窗: 8 week

The Action Research Arm Test (ARAT) is a clinical assessment tool used to evaluate upper limb function and recovery in individuals who have experienced a stroke or other neurological conditions affecting arm movement. The ARAT consists of a series of 19 items/tasks that assess different aspects of upper limb function, including reaching, grasping, gripping, and manipulating objects of various sizes and shapes. The tasks are scored based on the individual's ability to complete them successfully and the quality of movement exhibited during the task. Scores range from 0 to 3. (0=Unable to perform, 1= Partially performs the task, 2= Completes the task with some difficulty and 3= Completes the task without difficulty)

FMA-Upper Extremity

时间窗: 8 week

The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a clinical tool for evaluating motor recovery in stroke and neurological conditions affecting the upper limbs and with a sensitivity of 77%, a specificity of 89%. It assesses motor function through tasks like reaching and grasping, scored on a 3-point scale. Higher scores indicate better function, with a maximum score of 66. Clinicians use it to track progress, plan treatment, and assess outcomes in rehabilitation settings

次要结局

  • Stroke Specific Quality of Life(8 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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