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临床试验/NCT07428304
NCT07428304进行中(未招募)不适用

Effects of Upper Limb Immobilization on Sensorimotor Cortical Activity and Function Measured by EEG: A Prospective Observational Study

University of Malaga1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Change in Sensorimotor Cortical Activity Measured by EEG

研究概览

简要总结

This study aims to investigate how temporary immobilization of the upper limb after injury affects brain activity and functional recovery.

Participants with fractures or soft tissue injuries of the upper limb who require immobilization will be evaluated at three time points: at the beginning of immobilization, after removal of the immobilization, and four weeks later.

Brain activity will be measured using electroencephalography (EEG), a non-invasive and painless technique that records electrical signals from the scalp. Functional outcomes such as pain, mobility, strength, and daily activity performance will also be assessed using validated questionnaires and clinical tests.

The purpose of this study is to better understand how immobilization influences the brain and physical recovery, in order to improve rehabilitation strategies for patients with upper limb injuries.

Participation is voluntary, and all participants will provide written informed consent.

详细描述

Upper limb immobilization is commonly required after fractures and soft tissue injuries to promote healing. However, prolonged immobilization can lead to muscle weakness, sensory deficits, and changes in brain activity related to motor control.

Previous research has shown that even short periods of limb disuse can induce neuroplastic changes in the sensorimotor cortex. These changes may contribute to persistent functional limitations after immobilization is removed.

This prospective observational study aims to describe and quantify changes in sensorimotor cortical activity and functional outcomes associated with clinical immobilization of the upper limb.

Adult patients requiring immobilization for upper limb fractures or soft tissue injuries will be recruited. Eligible participants will be evaluated at three time points: baseline (within five days of immobilization), post-immobilization (within 24-48 hours after removal), and follow-up (four weeks after post-immobilization).

Brain activity will be recorded using a portable wireless electroencephalography (EEG) system following the international 10-20 electrode placement system. Resting-state and task-related recordings will be obtained. Spectral power in standard frequency bands and functional connectivity measures will be analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older.
  • Radiologically confirmed upper limb fracture (distal radius, proximal humerus, metacarpals, phalanges, or carpal bones) or soft tissue injury (e.g., tendinopathy, triangular fibrocartilage complex injury).
  • Requirement of orthopedic immobilization of the wrist/hand extending to the proximal two-thirds of the forearm for a minimum of 2 weeks and a maximum of 8 weeks.
  • Ability to understand study procedures and follow instructions.
  • Provision of written informed consent.

排除标准

  • History of neurological disorders (e.g., stroke, epilepsy, traumatic brain injury).
  • Current use of psychoactive or anticonvulsant medication.
  • Bilateral upper limb injuries.
  • Wrist fractures requiring elbow immobilization.
  • Previous upper limb fracture or instability within the last 2 years.
  • Cognitive impairment preventing adequate participation.

研究组 & 干预措施

Upper Limb Immobilization Cohort

Adults with upper limb fracture or soft tissue injury requiring orthopedic immobilization for 2-8 weeks. Participants undergo repeated neurophysiological and clinical assessments at baseline (within 5 days from the start of immobilization), post-immobilization (within 24-48 hours after removal of the immobilization), and 4-week follow-up (4 weeks after splint or cast removal).

干预措施: Orthopedic Immobilization (Other)

Upper Limb Immobilization Cohort

Adults with upper limb fracture or soft tissue injury requiring orthopedic immobilization for 2-8 weeks. Participants undergo repeated neurophysiological and clinical assessments at baseline (within 5 days from the start of immobilization), post-immobilization (within 24-48 hours after removal of the immobilization), and 4-week follow-up (4 weeks after splint or cast removal).

干预措施: Standard Rehabilitation (Other)

结局指标

主要结局

Change in Sensorimotor Cortical Activity Measured by EEG

时间窗: Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.

Changes in sensorimotor cortical activity measured using electroencephalography (EEG), including spectral power in mu (8-13 Hz) and beta (13-30 Hz) frequency bands over central regions (C3, C4 and adjacent electrodes), and functional connectivity between motor and somatosensory areas.

次要结局

  • Change in Upper Limb Pain and Disability (PRWE)(Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.)
  • Change in Upper Limb Functional Status (QuickDASH)(Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.)
  • Change in Hand Function (Michigan Hand Outcomes Questionnaire)(Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.)
  • Change in Shoulder Pain and Disability (SPADI)(Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.)
  • Change in Grip Strength(Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.)
  • Change in Wrist Range of Motion(Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.)
  • Change in Joint Position Sense (Proprioception)(Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.)
  • Change in Pain Catastrophizing (PCS)(Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.)
  • Change in Kinesiophobia (TSK-11)(Baseline (within 5 days of immobilization), 24-48 hours after immobilization removal, and 4 weeks post-removal.)

研究者

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

Atenea Villalobos-García

Principal investigator

University of Malaga

研究点 (1)

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