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临床试验/NCT06307834
NCT06307834尚未招募不适用

Restoring Grasp Ability in Stroke Survivors Through Motor Imagery-Based Training With EEG Feedback

North Carolina State University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024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
尚未招募
入组人数
20
试验地点
2
主要终点
Change of Action Research Arm Test (ARAT)

研究概览

简要总结

Stroke is a leading cause of disability. Most stroke survivors face challenge in using their arm and hand to carry out daily task, such as grasping or holding objects. This issue makes it tough for nearly 65% of stroke survivors to return to work and take care of themselves. The cause of their disability is changes in their brain's activity patterns of the motor cortex area. Traditional therapy does not directly alter these brain changes, which makes it less effective. As a way to help stroke survivors, people are looking into ways to train the brain directly. A method they found is motor imagery, which involves mental practicing of a task. Studies suggest that this type of training can potentially alter the brain's patterns, which can be seen through EEG. An EEG shows a fixed pattern during movement, called SMR (sensory motor rhythm). Studies have found that people can learn to control this SMR through mental practice of a task. The SMR changes in a similar way during both movement and motor imagery. Therefore, mental practice of hand tasks can lead to improvement in actual hand movements. It has already been shown that stroke survivors can open their hands more easily after receiving SMR training. Along with that, they also have trouble to hold and release objects. SMR training may be able to address these issues by changing brain patterns. But it is not clear yet if SMR training can improve all three stages of grasping (open, close, release), and to what extent it can enhance overall hand function.

This study plans to include 20 adults who have experienced a stroke and have ongoing problems with moving their hands. Half of these participants will take part in a training in which they will learn to control their SMR for three distinct hand tasks (open, close, and release). The first session will be followed by eight training sessions. To guide users toward specific changes in EEG activity, we will provide visual feedback in training. As soon as an appropriate EEG change is made, a hand exoskeleton will help them open and close their hand. The other group of 10 patients will have traditional therapy. They will do 9 sessions of hand exercises. During and after the training, we will test both groups to see how well their hand function improved. The result will help us determine which training method is better for stroke survivors.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 - 80 years
  • Stroke-induced hand disability in one hand
  • Experienced first stroke at least 6-month prior
  • Difficulty in opening the hand & grasping objects (Stage of Hand 4 or 5 on the Chedoke-McMaster Stroke Assessment (CMSA))
  • Ability to distinguish specific shapes and colors on a computer screen

排除标准

  • Inability to provide informed consent
  • Suffering from severe pain in the shoulder or hand
  • Having rigid contractures in the joints of the upper limbs, or orthopedic issues that prevent joint movement
  • Presence of non-stroke neurological diseases
  • Presence of severe cognitive deficits, such as unilateral spatial neglect or aphasia
  • Experience of hand disability due to reasons other than stroke
  • Having other serious medical conditions

研究组 & 干预措施

Neurofeedback - based therapy group

Experimental

In this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. Participants will be trained in modulating their brain activation patterns by using Mental Imagery (MI) involving various hand movements. EEG will be used to record brain responses. A visual feedback will be provided during the training to help achieve specific changes in brain responses. Once an appropriate brain response is achieved, an EMG-controlled hand exoskeleton will aid in opening and closing the hand.

干预措施: Neurofeedback - based therapy (Behavioral)

Standard Hand exercises therapy group

Active Comparator

In this arm/group, each participant will undergo a series of ten sessions (2-3 sessions per week) over a period of 3-5 weeks. At each session, participants will practice a particular set of hand exercises. In this intervention, a variety of games, tasks, and movements will be used to improve grasping abilities. These exercises will be personalized according to each participant's interests, which will be identified through the Canadian Occupational Performance Measure and will be guided by study personnel.

干预措施: Standard hand exercise therapy (Behavioral)

结局指标

主要结局

Change of Action Research Arm Test (ARAT)

时间窗: Change of value from before the intervention to immediately after the intervention

A standardized measure used to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery

Change of Wolf Motor Function Test (WMFT)

时间窗: Change of value from before the intervention to immediately after the intervention

A standardized, quantitative assessment used to assess upper extremity (UE) motor ability through timed and functional tasks

Change of Box & Block test (BBT)

时间窗: Change of value from before the intervention to immediately after the intervention

A quick, simple and inexpensive test used to assess and monitor unilateral gross manual dexterity

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

Derek Kamper

Associate Professor

North Carolina State University

研究点 (2)

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