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临床试验/NCT05339776
NCT05339776已完成不适用

Evaluation of Hand Lateralization Cognitive Task From Different Personal Perspectives by Using EEG Analysis Method in Amputees

Trakya University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年3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
已完成
入组人数
22
试验地点
1
主要终点
Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma

研究概览

简要总结

Studies on the improvement of body image or body perception have proven their effectiveness in different clinical situations such as pain management and chronic pain treatment. The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees. In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants. Data will be recorded via EEG and Eprime software program.

详细描述

The aim of this study is to evaluate the hand lateralization cognitive task by recording Electroencephalography (EEG) signals from different personal perspectives in amputees.

In this study, the paradigm in which personal perspectives are evaluated over the hand lateralization task will be applied to amputees and healthy volunteer participants.

It was planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Control group will be matched in terms of age and gender with the amputees group. Before hand lateralization test, participants will be evaluated regarding eligible criterias and EEG paradigm regarding hand lateralization will be performed for each participant.

Both groups (Amputees and Control) will complete "hand lateralization program" for at least 10 days. The test will be sent each day on an online system. Participants' performances will be recorded via online system.

Following 10-day period, EEG paradigm regarding hand lateralization will be performed for each participant, again.

研究设计

研究类型
Interventional
分配方式
Non 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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Control group:
  • •Inclusion Criteria:
  • •being between ages 18-65,
  • •consenting,
  • •with no limitation in mobility or movement disorder,
  • •A score of 21 or higher on the Montreal Cognitive Assessment Test

排除标准

  • •refuse to attend to the study,
  • •Having any mental, neurological or musculoskeletal problems,
  • •Inability to perform activities that require long-term attention,
  • •Inability to detect given commands,
  • •Using sedative drugs and/or derivatives
  • •Amputee group:
  • •Inclusion Criteria:
  • •between ages 18-65,
  • •using prosthesis,
  • •A score of 21 or higher on the Montreal Cognitive Assessment Test
  • •Exclusion Criteria:
  • •Having phantom pain,
  • •Having open wound on stump,
  • •Having any discomfort feeling on stump,
  • •Having any mental, neurological or musculoskeletal problems,
  • •Inability to perform activities that require long-term attention,
  • •Inability to detect given commands,
  • •Using sedative drugs and/or derivatives

研究组 & 干预措施

One of groups: amputees group

Active Comparator

We planned to enroll two groups to the study. One group is named "amputees" the other one is "control". Both groups will enroll "hand lateralization" for at least 10 days. Before and after comparisons will be analyzed.

干预措施: Hand Lateralization Test (Behavioral)

One of groups: control group

Active Comparator

Control group will be matched in terms of age and gender with the amputees group.

干预措施: Hand Lateralization Test (Behavioral)

结局指标

主要结局

Electroencephalogram (EEG) frequency bands: alpha, theta, beta, gamma

时间窗: Before and after the hand lateralization test: 10-14 days

Changes in power spectrum and phase locking

次要结局

  • Reaction time to decide whether the hand is right or left(Before and after the hand lateralization test: 10-14 days)
  • Accuracy proportion of given answers regarding hand lateralization(Before and after the hand lateralization test: 10-14 days)

研究者

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

Burcu Dilek

PhD, Principal Investigator

Trakya University

研究点 (1)

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